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Sample records for skin irritation tests

  1. Comparison of human skin irritation patch test data with in vitro skin irritation assays and animal data.

    PubMed

    Jírová, Dagmar; Basketter, David; Liebsch, Manfred; Bendová, Hana; Kejlová, Kristina; Marriott, Marie; Kandárová, Helena

    2010-02-01

    Efforts to replace the rabbit skin irritation test have been underway for many years, encouraged by the EU Cosmetics Directive and REACH. Recently various in vitro tests have been developed, evaluated and validated. A key difficulty in confirming the validity of in vitro methods is that animal data are scarce and of limited utility for prediction of human effects, which adversely impacts their acceptance. This study examines whether in vivo or in vitro data most accurately predicted human effects. Using the 4-hr human patch test (HPT) we examined a number of chemicals whose EU classification of skin irritancy is known to be borderline, or where in vitro methods provided conflicting results. Of the 16 chemicals classified as irritants in the rabbit, only five substances were found to be significantly irritating to human skin. Concordance of the rabbit test with the 4-hr HPT was only 56%, whereas concordance of human epidermis models with human data was 76% (EpiDerm) and 70% (EPISKIN). The results confirm observations that rabbits overpredict skin effects in humans. Therefore, when validating in vitro methods, all available information, including human data, should be taken into account before making conclusions about their predictive capacity.

  2. A new alternative method for testing skin irritation using a human skin model: a pilot study.

    PubMed

    Miles, A; Berthet, A; Hopf, N B; Gilliet, M; Raffoul, W; Vernez, D; Spring, P

    2014-03-01

    Studies assessing skin irritation to chemicals have traditionally used laboratory animals; however, such methods are questionable regarding their relevance for humans. New in vitro methods have been validated, such as the reconstructed human epidermis (RHE) model (Episkin®, Epiderm®). The comparison (accuracy) with in vivo results such as the 4-h human patch test (HPT) is 76% at best (Epiderm®). There is a need to develop an in vitro method that better simulates the anatomo-pathological changes encountered in vivo. To develop an in vitro method to determine skin irritation using human viable skin through histopathology, and compare the results of 4 tested substances to the main in vitro methods and in vivo animal method (Draize test). Human skin removed during surgery was dermatomed and mounted on an in vitro flow-through diffusion cell system. Ten chemicals with known non-irritant (heptylbutyrate, hexylsalicylate, butylmethacrylate, isoproturon, bentazon, DEHP and methylisothiazolinone (MI)) and irritant properties (folpet, 1-bromohexane and methylchloroisothiazolinone (MCI/MI)), a negative control (sodiumchloride) and a positive control (sodiumlaurylsulphate) were applied. The skin was exposed at least for 4h. Histopathology was performed to investigate irritation signs (spongiosis, necrosis, vacuolization). We obtained 100% accuracy with the HPT model; 75% with the RHE models and 50% with the Draize test for 4 tested substances. The coefficients of variation (CV) between our three test batches were <0.1, showing good reproducibility. Furthermore, we reported objectively histopathological irritation signs (irritation scale): strong (folpet), significant (1-bromohexane), slight (MCI/MI at 750/250ppm) and none (isoproturon, bentazon, DEHP and MI). This new in vitro test method presented effective results for the tested chemicals. It should be further validated using a greater number of substances; and tested in different laboratories in order to suitably

  3. The identification and classification of skin irritation hazard by a human patch test.

    PubMed

    Basketter, D A; Whittle, E; Griffiths, H A; York, M

    1994-08-01

    There exist various regulatory instruments the purpose of which is to ensure that the intrinsic toxic hazards associated with substances and preparations are identified. In the context of identification of skin irritation potential, the method is normally the Draize test. Guidance notes provided by the OECD and the EEC expect that corrosive substances will have been screened out by a variety of methods. Substances or preparations which cause a sufficient degree of skin irritation will be classified as skin irritants. The primary motivation behind the present work was to introduce the concept that it is possible to assess the hazard potential of a substance or preparation to produce skin irritation in a human study. In the example presented here, 20% sodium lauryl sulfate (SLS) has been chosen as the positive control. With the protocol currently devised, occluded patch treatment with 20% SLS for up to 4 hr produces an irritant response in just over half of the panel. An irritant response is taken as a clinically evident and significant increase in erythema, oedema or dryness--a minimum of a+ reaction on the ICDRG scale. At such a level of response with the positive control (both in terms of intensity and in proportion of the panel), it is then possible to judge and/or to determine statistically, whether the test material has produced a level of skin irritation which is similar to, greater, or lower than the positive control. In this way a human patch test protocol can form a fundamental component of a strategy for the replacement of animals in determination of skin irritation and corrosion potential. By use of a careful and progressive protocol and by comparison of test data against a positive control it is both possible and practical to classify substances and preparations in terms of their skin irritation potential using that endpoint in the species of concern, man.

  4. An approach for development of alternative test methods based on mechanisms of skin irritation.

    PubMed

    Osborne, R; Perkins, M A

    1994-02-01

    Recent advances in techniques for culture of human skin cells have led to their potential for use as in vitro models for skin irritation testing to augment or replace existing rabbit skin patch tests. Our work is directed towards the development of cultured human skin cells, together with endpoints that can be linked to in vivo mechanisms of skin irritation, as in vitro models for prediction of human skin irritation, and for study of mechanisms of contact irritant dermatitis. Three types of commercial human skin cell cultures have been evaluated, epidermal keratinocytes and partially or fully cornified keratinocyte-dermal fibroblast co-cultures. Human epidermal keratinocyte cultures (Clonetics) were treated with product ingredients and formulations, and the extent of cell damage was assessed by incorporation of the vital dye neutral red. Cell damage correlated with human skin patch data for ingredient chemicals with the exception of acids and alkalis, but did not correlate with skin irritation to surfactant-containing product formulations. Cultures of human skin equivalents were evaluated as potential models for measurement of responses to test materials that could not be measured in the keratinocyte/neutral red assay. We developed a battery of in vitro endpoints to measure responses to prototype ingredients and formulations in human epidermal keratinocyte-dermal fibroblast co-cultures grown on a nylon mesh ('Skin2' from Advanced Tissue Sciences) or on a collagen gel ('Testskin' from Organogenesis). The endpoints measure cytotoxicity (neutral red and MTT vital dye staining, lactate dehydrogenase and N-acetyl glucosaminidase release, glucose utilization) and inflammatory mediator (prostaglandin E2) release. Initial experiments indicate a promising correlation between responses of the Skin2 model to prototype surfactants and in vivo human skin irritation. The responses of Testskin cultures to acids and alkalis help to prove the concept that a topical application

  5. CON4EI: SkinEthic™ Human Corneal Epithelium Eye Irritation Test (SkinEthic™ HCE EIT) for hazard identification and labelling of eye irritating chemicals.

    PubMed

    Van Rompay, A R; Alépée, N; Nardelli, L; Hollanders, K; Leblanc, V; Drzewiecka, A; Gruszka, K; Guest, R; Kandarova, H; Willoughby, J A; Verstraelen, S; Adriaens, E

    2018-06-01

    Assessment of ocular irritancy is an international regulatory requirement and a necessary step in the safety evaluation of industrial and consumer products. Although a number of in vitro ocular irritation assays exist, none are capable of fully categorizing chemicals as a stand-alone assay. Therefore, the CEFIC-LRI-AIMT6-VITO CON4EI (CONsortium for in vitro Eye Irritation testing strategy) project was developed with the goal of assessing the reliability of eight in vitro/alternative test methods as well as establishing an optimal tiered-testing strategy. One of the in vitro assays selected was the validated SkinEthic™ Human Corneal Epithelium Eye Irritation Test method (SkinEthic™ HCE EIT). The SkinEthic™ HCE EIT has already demonstrated its capacity to correctly identify chemicals (both substances and mixtures) not requiring classification and labelling for eye irritation or serious eye damage (No Category). The goal of this study was to evaluate the performance of the SkinEthic™ HCE EIT test method in terms of the important in vivo drivers of classification. For the performance with respect to the drivers all in vivo Cat 1 and No Cat chemicals were 100% correctly identified. For Cat 2 chemicals the liquids and the solids had a sensitivity of 100% and 85.7%, respectively. For the SkinEthic™ HCE EIT test method, 100% concordance in predictions (No Cat versus No prediction can be made) between the two participating laboratories was obtained. The accuracy of the SkinEthic™ HCE EIT was 97.5% with 100% sensitivity and 96.9% specificity. The SkinEthic™ HCE EIT confirms its excellent results of the validation studies. Copyright © 2017. Published by Elsevier Ltd.

  6. Assessment of test method variables for in vitro skin irritation testing of medical device extracts.

    PubMed

    Olsen, Daniel S; Lee, Michelle; Turley, Audrey P

    2018-08-01

    Skin irritation is an important component of the biological safety evaluation of medical devices. This testing has typically been performed using in vivo models. However, in an effort to reduce the need for in vivo testing, alternative methods for assessing skin irritation potential in vitro have been developed using a Reconstructed Human Epidermis (RhE) model. During the development of the protocol for the round robin validation of in vitro irritation testing for medical device extracts, it became clear that there were three points in the procedure where different options may be validated within each laboratory for routine testing: sample exposure time (18 vs 24h), SDS positive control concentration, and cytokine (IL-1α) release testing. The goal of our study was to evaluate the effect of these variables. EpiDerm™ tissues were exposed to extracts of three plain polymer samples, and four polymers embedded with known irritant chemicals. Exposures were performed for 18 and 24h. Resulting tissue viability was assessed by MTT reduction and IL-1α release was assessed by ELISA. Testing was also performed using various concentrations of SDS ranging from 0.5 to 1% (w/v). Overall, results were similar for samples tested and 18 and 24h, but the 18h exposure time has the potential to have an impact on the results of some sample types. IL-1α testing was shown to be useful to clarify conflicting tissue viability results. Use of a lower concentration of SDS as a positive control can help prevent issues that arise from excessive tissue damage often caused by 1% SDS. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. Skin irritability to sodium lauryl sulfate is associated with increased positive patch test reactions.

    PubMed

    Schwitulla, J; Brasch, J; Löffler, H; Schnuch, A; Geier, J; Uter, W

    2014-07-01

    As previous observations have indicated an inter-relationship between irritant and allergic skin reactions we analysed data of synchronous allergen and sodium lauryl sulfate (SLS) patch tests in terms of a relationship between SLS responsiveness and allergic patch test reactions. To analyse differences in terms of allergen-specific and overall reaction profiles between patients with vs. those without an irritant reaction to SLS. Clinical data of 26 879 patients patch tested from 2008 to 2011 by members of the Information Network of Departments of Dermatology were analysed. After descriptive analyses, including the MOAHLFA index, the positivity ratio and the reaction index, a negative binomial hurdle model was adopted to investigate the correlation between SLS reactivity and positive patch test reactions. Men, patients aged ≥ 40 years and patients with an occupational dermatitis background were over-represented in the SLS-reactive group. Patients with an irritant reaction to SLS showed a higher proportion of weak positive reactions, as well as more questionable and irritant reactions to contact allergens than patients not reactive to SLS. The risk of an additional positive patch test reaction increased by 22% for SLS-reactive patients compared with those who were SLS negative. The marked association between SLS reactivity and the number of positive reactions in patch test patients may be due to nonspecific increased skin reactivity at the moment of patch testing only. However, increased SLS reactivity could also be due to longer-lasting enhanced skin irritability, which may have promoted (poly-)sensitization. Further studies, for example with longitudinal data on patients repeatedly patch tested with SLS and contact allergens, are necessary. © 2014 British Association of Dermatologists.

  8. Proof of concept testing of a positive reference material for in vivo and in vitro skin irritation testing.

    PubMed

    Nomura, Yusuke; Lee, Michelle; Fukui, Chie; Watanabe, Kayo; Olsen, Daniel; Turley, Audrey; Morishita, Yuki; Kawakami, Tsuyoshi; Yuba, Toshiyasu; Fujimaki, Hideo; Inoue, Kaoru; Yoshida, Midori; Ogawa, Kumiko; Haishima, Yuji

    2017-12-11

    In vivo and in vitro irritation testing is important for evaluating the biological safety of medical devices. Here, the performance of positive reference materials for skin irritation testing was evaluated. Four reference standards, referred to as Y-series materials, were analyzed: a polyvinyl chloride (PVC) sheet spiked with 0 (Y-1), 1.0 (Y-2), 1.5 (Y-3), or 10 (Y-4) parts of Genapol X-080 per 100 parts of PVC by weight. Y-1, Y-2, and Y-3 did not induce skin irritation responses in an in vitro reconstructed human epidermis (RhE) tissue model, as measured by tissue viability or interleukin-1α release, or in an in vivo intracutaneous response test using rabbits. In contrast, Y-4 extracts prepared with saline or sesame oil at 37°C and 50°C clearly elicited positive irritation responses, including reduced viability (< 50%) and significantly higher interleukin-1α release compared with the solvent alone group, in the RhE tissue model and an intracutaneous response test, where substantial necrosis was observed by histopathology. The positive skin irritation responses induced in vitro under various extraction conditions, as well as those elicited in vivo, indicate that Y-4 is an effective extractable positive control material for in vivo and in vitro skin irritation tests of medical devices. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2017. © 2017 Wiley Periodicals, Inc.

  9. Non-occlusive topical exposure of human skin in vitro as model for cytotoxicity testing of irritant compounds.

    PubMed

    Lönnqvist, Susanna; Briheim, Kristina; Kratz, Gunnar

    2016-02-01

    Testing of irritant compounds has traditionally been performed on animals and human volunteers. Animal testing should always be restricted and for skin irritancy mice and rabbits hold poor predictive value for irritant potential in humans. Irritant testing on human volunteers is restricted by the duration subjects can be exposed, and by the subjectivity of interpreting the visual signs of skin irritation. We propose an irritant testing system using viable human full thickness skin with the loss of cell viability in the exposed skin area as end point measurement. Skin was exposed to sodium dodecyl sulfate (SDS) at 20% concentration by non-occluded topical exposure to establish a positive control response and subsequent test compounds were statistically compared with the 20% SDS response. Cell viability and metabolism were measured with 3-(4,5-dimethyl-thiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) assay. The model presents correlation between increased concentration of SDS and decreased viability of cells in the exposed skin area (R(2) = 0.76). We propose the model to be used for cytotoxicity testing of irritant compounds. With fully intact barrier function, the model comprises all cells present in the skin with quantifiable end point measurement.

  10. A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: skin irritation.

    PubMed

    Macfarlane, Martin; Jones, Penny; Goebel, Carsten; Dufour, Eric; Rowland, Joanna; Araki, Daisuke; Costabel-Farkas, Margit; Hewitt, Nicola J; Hibatallah, Jalila; Kirst, Annette; McNamee, Pauline; Schellauf, Florian; Scheel, Julia

    2009-07-01

    Evaluation of the skin irritancy and corrosivity potential of an ingredient is a necessity in the safety assessment of cosmetic ingredients. To date, there are two formally validated alternatives to the rabbit Draize test for skin corrosivity in place, namely the rat skin transcutaneous electrical resistance (TER) assay and the Human Skin Model Test using EpiSkin, EpiDerm and SkinEthic reconstructed human epidermal equivalents. For skin irritation, EpiSkin, EpiDerm and SkinEthic are validated as stand-alone test replacements for the rabbit Draize test. Data from these tests are rarely considered in isolation and are evaluated in combination with other factors to establish the overall irritating or corrosive potential of an ingredient. In light of the deadlines established in the Cosmetics Directive for cessation of animal testing for cosmetic ingredients, a COLIPA scientific meeting was held in Brussels on 30th January, 2008 to review the use of alternative approaches and to set up a decision tree approach for their integration into tiered testing strategies for hazard and safety assessment of cosmetic ingredients and their use in products. In conclusion, the safety assessments for skin irritation/corrosion of new chemicals for use in cosmetics can be confidently accomplished using exclusively alternative methods.

  11. Effects of different base agents on prediction of skin irritation by sodium lauryl sulfate using patch testing and repeated application test.

    PubMed

    Horita, Kotomi; Horita, Daisuke; Tomita, Hiroyuki; Yasoshima, Mitsue; Yagami, Akiko; Matsunaga, Kayoko

    2017-05-01

    Animal testing for cosmetics was banned in the European Union (EU) in 2013; therefore, human tests to predict and ensure skin safety such as the patch test or usage test are now in demand in Japan as well as in the EU. In order to investigate the effects of different bases on the findings of tests to predict skin irritation, we performed patch testing (PT) and the repeated application test (RAT) using sodium lauryl sulfate (SLS), a well-known irritant, dissolved in 6 different base agents to examine the effects of these bases on skin irritation by SLS. The bases for PT were distilled water, 50% ethanol, 100% ethanol, a gel containing 50% ethanol, white petrolatum, and hydrophilic cream. The concentrations of SLS were 0.2% and 0.5%. Twelve different base combinations were applied to the normal back skin of 19 individuals for 24h. RAT was performed with distilled water, 50% ethanol, 100% ethanol, a gel containing 50% ethanol, white petrolatum, and hydrophilic cream containing SLS at concentrations of 0.2%, 2%, and 5%, being applied to the arms of the same PT subjects. The test preparation of each base was applied at the same site, with 0.2% SLS being used in the first week, 2% SLS in the following week, and 5% SLS in the final week. The results of PT revealed that skin irritation scores varied when SLS at the same concentration was dissolved in a different base. The results of RAT showed that although skin irritation appeared with every base at a concentration of 5%, the positive rate was approximately the same. In conclusion, our results suggest that skin irritation elicited in PT depends on the base, while in RAT, it does not depend on the type of base employed. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Validation study of the in vitro skin irritation test with the LabCyte EPI-MODEL24.

    PubMed

    Kojima, Hajime; Ando, Yoko; Idehara, Kenji; Katoh, Masakazu; Kosaka, Tadashi; Miyaoka, Etsuyoshi; Shinoda, Shinsuke; Suzuki, Tamie; Yamaguchi, Yoshihiro; Yoshimura, Isao; Yuasa, Atsuko; Watanabe, Yukihiko; Omori, Takashi

    2012-03-01

    A validation study on an in vitro skin irritation assay was performed with the reconstructed human epidermis (RhE) LabCyte EPI-MODEL24, developed by Japan Tissue Engineering Co. Ltd (Gamagori, Japan). The protocol that was followed in the current study was an optimised version of the EpiSkin protocol (LabCyte assay). According to the United Nations Globally Harmonised System (UN GHS) of classification for assessing the skin irritation potential of a chemical, 12 irritants and 13 non-irritants were validated by a minimum of six laboratories from the Japanese Society for Alternatives to Animal Experiments (JSAAE) skin irritation assay validation study management team (VMT). The 25 chemicals were listed in the European Centre for the Validation of Alternative Methods (ECVAM) performance standards. The reconstructed tissues were exposed to the chemicals for 15 minutes and incubated for 42 hours in fresh culture medium. Subsequently, the level of interleukin-1 alpha (IL-1 α) present in the conditioned medium was measured, and tissue viability was assessed by using the MTT assay. The results of the MTT assay obtained with the LabCyte EPI-MODEL24 (LabCyte MTT assay) demonstrated high within-laboratory and between-laboratory reproducibility, as well as high accuracy for use as a stand-alone assay to distinguish skin irritants from non-irritants. In addition, the IL-1α release measurements in the LabCyte assay were clearly unnecessary for the success of this model in the classification of chemicals for skin irritation potential. 2012 FRAME.

  13. Catch-up validation study of an in vitro skin irritation test method based on an open source reconstructed epidermis (phase II).

    PubMed

    Groeber, F; Schober, L; Schmid, F F; Traube, A; Kolbus-Hernandez, S; Daton, K; Hoffmann, S; Petersohn, D; Schäfer-Korting, M; Walles, H; Mewes, K R

    2016-10-01

    To replace the Draize skin irritation assay (OECD guideline 404) several test methods based on reconstructed human epidermis (RHE) have been developed and were adopted in the OECD test guideline 439. However, all validated test methods in the guideline are linked to RHE provided by only three companies. Thus, the availability of these test models is dependent on the commercial interest of the producer. To overcome this limitation and thus to increase the accessibility of in vitro skin irritation testing, an open source reconstructed epidermis (OS-REp) was introduced. To demonstrate the capacity of the OS-REp in regulatory risk assessment, a catch-up validation study was performed. The participating laboratories used in-house generated OS-REp to assess the set of 20 reference substances according to the performance standards amending the OECD test guideline 439. Testing was performed under blinded conditions. The within-laboratory reproducibility of 87% and the inter-laboratory reproducibility of 85% prove a high reliability of irritancy testing using the OS-REp protocol. In addition, the prediction capacity was with an accuracy of 80% comparable to previous published RHE based test protocols. Taken together the results indicate that the OS-REp test method can be used as a standalone alternative skin irritation test replacing the OECD test guideline 404. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  14. Evaluation of fibrin-based dermal-epidermal organotypic cultures for in vitro skin corrosion and irritation testing of chemicals according to OECD TG 431 and 439.

    PubMed

    Morales, Mariana; Pérez, David; Correa, Luis; Restrepo, Luz

    2016-10-01

    Reconstructed human epidermis (RhE) models have been used for in vitro testing of the potential harmful effects of exposure to chemical compounds on health. In the past, skin irritation and corrosion were evaluated in animal models; however, in recent years, due to the bioethics implications of the method and, to minimize the use of experimental animals, alternative procedures have been proposed. The Organisation for Economic Co-operation and Development (OECD) in its test guidelines (TG) 431 and 439 indicates the requirements for validating new methods for the evaluation of skin corrosion and irritation, respectively. Here, we present an in-house human dermal-epidermal model, useful for the performance of these tests. Using the methods described in this work, it was possible to obtain human fibrin-based dermal-epidermal organotypic skin cultures (ORGs) displaying similar histological characteristics to native skin and expressing specific differentiation epithelial proteins. The end points to classify a substance as irritant or corrosive were cell viability evaluated by MTT assay, and cytokine release measured by BD CBA for human inflammatory cytokines. According to the MTT test, the ORGs correctly classified irritating and corrosive substances. Moreover, the cytokine release assay was difficult to interpret in the context of testing chemical hazard classification. Further experiments are needed to validate this new model for the evaluation of surfactants because the fibrin matrix was affected in the presence of these substances. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. Alternatives to In Vivo Draize Rabbit Eye and Skin Irritation Tests with a Focus on 3D Reconstructed Human Cornea-Like Epithelium and Epidermis Models

    PubMed Central

    Lee, Miri; Hwang, Jee-Hyun; Lim, Kyung-Min

    2017-01-01

    Human eyes and skin are frequently exposed to chemicals accidentally or on purpose due to their external location. Therefore, chemicals are required to undergo the evaluation of the ocular and dermal irritancy for their safe handling and use before release into the market. Draize rabbit eye and skin irritation test developed in 1944, has been a gold standard test which was enlisted as OECD TG 404 and OECD TG 405 but it has been criticized with respect to animal welfare due to invasive and cruel procedure. To replace it, diverse alternatives have been developed: (i) For Draize eye irritation test, organotypic assay, in vitro cytotoxicity-based method, in chemico tests, in silico prediction model, and 3D reconstructed human cornea-like epithelium (RhCE); (ii) For Draize skin irritation test, in vitro cytotoxicity-based cell model, and 3D reconstructed human epidermis models (RhE). Of these, RhCE and RhE models are getting spotlight as a promising alternative with a wide applicability domain covering cosmetics and personal care products. In this review, we overviewed the current alternatives to Draize test with a focus on 3D human epithelium models to provide an insight into advancing and widening their utility. PMID:28744350

  16. Effect of topically applied lipids on surfactant-irritated skin.

    PubMed

    Lodén, M; Andersson, A C

    1996-02-01

    Moisturizers are used daily by many people to alleviate symptoms of dry skin. All of them contain lipids. It has been suggested that topically applied lipids may interfere with the structure and function of the permeability barrier. The influence of a single application of nine different lipids on normal skin and skin irritated by sodium lauryl sulphate (SLS) was studied in 21 healthy subjects. Parameters assessed were visible signs of irritation, and objectively measured cutaneous blood flow and transepidermal water loss (TEWL). The substances tested were hydrocortisone, petrolatum, fish oil, borage oil, sunflower seed oil, canola oil, shea butter, and fractions of unsaponifiable lipids from canola oil and shea butter. Water was included as a control. On normal skin, no significant differences in the effects of the test substances were found, whereas significant differences were observed when they were applied to SLS-irritated skin. The visible signs of SLS-induced irritation were significantly less pronounced after treatment with the sterol-enriched fraction from canola oil than after treatment with water. This fraction, and hydrocortisone, reduced cutaneous blood flow. Furthermore, application of hydrocortisone, canola oil, and its sterol-enriched fraction, resulted in significantly lower TEWL than with water. The other lipids had no effect on the degree of irritation. In conclusion, lipids commonly used in moisturizers may reduce skin reactions to irritants. Previous studies have shown that, in barrier perturbed skin, the synthesis of sterols is increased. The observed effects of canola oil and its fraction of unsaponifiable lipids on SLS-induced irritation suggest the possibility that they assisted the skin in supplying the damaged barrier with adequate lipids.

  17. Assessment of human epidermal model LabCyte EPI-MODEL for in vitro skin irritation testing according to European Centre for the Validation of Alternative Methods (ECVAM)-validated protocol.

    PubMed

    Katoh, Masakazu; Hamajima, Fumiyasu; Ogasawara, Takahiro; Hata, Ken-Ichiro

    2009-06-01

    A validation study of an in vitro skin irritation testing method using a reconstructed human skin model has been conducted by the European Centre for the Validation of Alternative Methods (ECVAM), and a protocol using EpiSkin (SkinEthic, France) has been approved. The structural and performance criteria of skin models for testing are defined in the ECVAM Performance Standards announced along with the approval. We have performed several evaluations of the new reconstructed human epidermal model LabCyte EPI-MODEL, and confirmed that it is applicable to skin irritation testing as defined in the ECVAM Performance Standards. We selected 19 materials (nine irritants and ten non-irritants) available in Japan as test chemicals among the 20 reference chemicals described in the ECVAM Performance Standard. A test chemical was applied to the surface of the LabCyte EPI-MODEL for 15 min, after which it was completely removed and the model then post-incubated for 42 hr. Cell v iability was measured by MTT assay and skin irritancy of the test chemical evaluated. In addition, interleukin-1 alpha (IL-1alpha) concentration in the culture supernatant after post-incubation was measured to provide a complementary evaluation of skin irritation. Evaluation of the 19 test chemicals resulted in 79% accuracy, 78% sensitivity and 80% specificity, confirming that the in vitro skin irritancy of the LabCyte EPI-MODEL correlates highly with in vivo skin irritation. These results suggest that LabCyte EPI-MODEL is applicable to the skin irritation testing protocol set out in the ECVAM Performance Standards.

  18. NEUROPEPTIDE MODULATION OF CHEMICALLY INDUCED SKIN IRRITATION

    EPA Science Inventory

    This study was designed to demonstrate that the early symptoms of chemically-induced skin irritation are neurally mediated. everal approaches were used to affect nerve transmission in adult Balb/c female mice. hese included general anesthesia (i.e., sodium pentobarbital), systemi...

  19. HSP27 as a biomarker for predicting skin irritation in human skin and reconstructed organotypic skin model.

    PubMed

    Chen, Hongxia; Li, Shuhua; Meng, Tian; Zhang, Lei; Dai, Taoli; Xiang, Qi; Su, Zhijian; Zhang, Qihao; Huang, Yadong

    2014-04-21

    In vitro alternative tests aiming at replacing the traditional animal test for predicting the irritant potential of chemicals have been developed, but the assessing parameters or endpoints are still not sufficient. To discover novel endpoints for skin irritation responses, 2DE-based proteomics was used to analyze the protein expression in human skin exposed to sodium lauryl sulfate (SLS) following the test protocol of the European Centre for the Validation of Alternative Methods (ECVAM) in the present study. HSP27 was up-regulated most significantly among the eight identified proteins, consistent with our previous reports. Acid and basic chemicals were applied on human skin for further validation and results showed that the up-regulated expression of HSP27 was induced in 24h after the exposure. Skin-equivalent constructed with fibroblasts, basement membrane and keratinocytes was used to investigate the potential of HSP27 as a biomarker or additional endpoint for the hazard assessment of skin irritation. Our skin-equivalent (Reconstructed Organotypic Skin Model, ROSM) had excellent epidermal differentiation and was suitable for the skin irritation test. HSP27 also displayed an up-regulated expression in the ROSM in 24h after the irritants exposure for 15min. All these results suggest that HSP27 may represent a potential marker or additional endpoint for the hazard assessment of skin irritation caused by chemical products. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  20. A catch-up validation study of an in vitro skin irritation test method using reconstructed human epidermis LabCyte EPI-MODEL24.

    PubMed

    Kojima, Hajime; Katoh, Masakazu; Shinoda, Shinsuke; Hagiwara, Saori; Suzuki, Tamie; Izumi, Runa; Yamaguchi, Yoshihiro; Nakamura, Maki; Kasahawa, Toshihiko; Shibai, Aya

    2014-07-01

    Three validation studies were conducted by the Japanese Society for Alternatives to Animal Experiments in order to assess the performance of a skin irritation assay using reconstructed human epidermis (RhE) LabCyte EPI-MODEL24 (LabCyte EPI-MODEL24 SIT) developed by the Japan Tissue Engineering Co., Ltd. (J-TEC), and the results of these studies were submitted to the Organisation for Economic Co-operation and Development (OECD) for the creation of a Test Guideline (TG). In the summary review report from the OECD, the peer review panel indicated the need to resolve an issue regarding the misclassification of 1-bromohexane. To this end, a rinsing operation intended to remove exposed chemicals was reviewed and the standard operating procedure (SOP) revised by J-TEC. Thereafter, in order to confirm general versatility of the revised SOP, a new validation management team was organized by the Japanese Center for the Validation of Alternative Methods (JaCVAM) to undertake a catch-up validation study that would compare the revised assay with similar in vitro skin irritation assays, per OECD TG No. 439 (2010). The catch-up validation and supplementary studies for LabCyte EPI-MODEL24 SIT using the revised SOPs were conducted at three laboratories. These results showed that the revised SOP of LabCyte EPI-MODEL24 SIT conformed more accurately to the classifications for skin irritation under the United Nations Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS), thereby highlighting the importance of an optimized rinsing operation for the removal of exposed chemicals in obtaining consistent results from in vitro skin irritation assays. Copyright © 2013 John Wiley & Sons, Ltd.

  1. In vivo skin penetration of macromolecules in irritant contact dermatitis.

    PubMed

    Abdel-Mottaleb, Mona M A; Lamprecht, Alf

    2016-12-30

    Recently, a selective preferential accumulation of polymeric nanoparticles (in the size range around 100nm) has been observed in the follicular system of dermatitis skin. The present investigation aimed at clearly investigating the effect of irritant contact dermatitis on the barrier permeability for colloidal systems below this size range, namely quantum dots and hydrophilic macromolecules. Irritant dermatitis was induced in mice and the penetrability of quantum dots (5nm) and hydrophilic dextran molecules has been tracked in both healthy and inflamed skin using confocal laser scanning microscopy. The selective accumulation of the quantum dots was clearly observed in inflamed skin while hydrophilic dextran behaved similarly in both healthy and inflamed skin. The therapeutic potential for the transdermal delivery of peptide drugs through inflamed skin has been also tested in rats. Results revealed that the transdermal permeation of insulin and calcitonin was not significantly enhanced in dermatitis compared to healthy skin. On the other side, permeation through stripped skin was significantly higher. However, the effect was limited and shorter compared to the SC injection where t min was 0.5h and 2h with a 70% and 46% reduction in blood glucose levels for the stripped skin and the SC injection respectively. Similarly, t min was 4h and 8h with area under the curve of 161±65% and 350±97% for the stripped skin and the SC injection respectively. In conclusion, the changes in skin permeability accompanied with skin inflammation did not affect its permeability to peptide drugs. Our findings also underline that experiments with the tape stripped skin model as a surrogate for inflamed skin can risk misleading conclusions due to significant difference of skin permeability between the tape stripped skin and inflamed skin. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Formulation of tretinoin-loaded topical proniosomes for treatment of acne: in-vitro characterization, skin irritation test and comparative clinical study.

    PubMed

    Rahman, Salwa Abdel; Abdelmalak, Nevine Shawky; Badawi, Alia; Elbayoumy, Tahany; Sabry, Nermeen; El Ramly, Amany

    2015-01-01

    Tretinoin (TRT) is a widely used retinoid for the topical treatment of acne, photo-aged skin, psoriasis and skin cancer which makes it a good candidate for topical formulation. Yet side effects, like redness, swelling, peeling, blistering and, erythema, in addition to its high lipophilicity make this challenging. Therefore, the aim of this study was the development of TRT-loaded proniosomes to improve the drug efficacy and to increase user acceptability and compliance by reducing its side effects. Nine formulae were prepared according to 3(2) factorial design and were evaluated for their morphology, vesicle size, entrapment efficiency (EE %), and% of drug released after 5 h. Hydrogel of the candidate formula, N8G (proniosomes prepared with 0.025% TRT, and Span60: cholesterol molar ratio of 3:1 and incorporated in 1% carbopol gel) was developed and evaluated for skin irritation test and clinical study in acne patients compared to marketed product. Candidate formula showed higher efficacy and very low irritation potential when compared to marketed product in human volunteers.

  3. Cosmetics Europe multi-laboratory pre-validation of the SkinEthic™ reconstituted human corneal epithelium test method for the prediction of eye irritation.

    PubMed

    Alépée, N; Bessou-Touya, S; Cotovio, J; de Smedt, A; de Wever, B; Faller, C; Jones, P; Le Varlet, B; Marrec-Fairley, M; Pfannenbecker, U; Tailhardat, M; van Goethem, F; McNamee, P

    2013-08-01

    Cosmetics Europe, The Personal Care Association, known as Colipa before 2012, conducted a program of technology transfer and assessment of Within/Between Laboratory (WLV/BLV) reproducibility of the SkinEthic™ Reconstituted Human Corneal Epithelium (HCE) as one of two human reconstructed tissue eye irritation test methods. The SkinEthic™ HCE test method involves two exposure time treatment procedures - one for short time exposure (10 min - SE) and the other for long time exposure (60 min - LE) of tissues to test substance. This paper describes pre-validation studies of the SkinEthic™ HCE test method (SE and LE protocols) as well as the Eye Peptide Reactivity Assay (EPRA). In the SE WLV study, 30 substances were evaluated. A consistent outcome with respect to viability measurement across all runs was observed with all substances showing an SD of less than 18%. In the LE WLV study, 44 out of 45 substances were consistently classified. These data demonstrated a high level of reproducibility within laboratory for both the SE and LE treatment procedures. For the LE BLV, 19 out of 20 substances were consistently classified between the three laboratories, again demonstrating a high level of reproducibility between laboratories. The results for EPRA WLV and BLV studies demonstrated that all substances analysed were categorised similarly and that the method is reproducible. The SkinEthic™ HCE test method entered into the experimental phase of a formal ECVAM validation program in 2010. Copyright © 2013. Published by Elsevier Ltd.

  4. Tandem repeated application of organic solvents and sodium lauryl sulphate enhances cumulative skin irritation.

    PubMed

    Schliemann, Sibylle; Schmidt, Christina; Elsner, Peter

    2014-01-01

    The objective of our study was to investigate the tandem irritation potential of two organic solvents with concurrent exposure to the hydrophilic detergent irritant sodium lauryl sulphate (SLS). A tandem repeated irritation test was performed with two undiluted organic solvents, cumene (C) and octane (O), with either alternating application with SLS 0.5% or twice daily application of each irritant alone in 27 volunteers on the skin of the back. The cumulative irritation induced over 4 days was quantified using visual scoring and non-invasive bioengineering measurements (skin colour reflectance, skin hydration and transepidermal water loss). Repeated application of C/SLS and O/SLS induced more decline of stratum corneum hydration and higher degrees of clinical irritation and erythema compared to each irritant alone. Our results demonstrate a further example of additive harmful skin effects induced by particular skin irritants and indicate that exposure to organic solvents together with detergents may increase the risk of acquiring occupational contact dermatitis. © 2014 S. Karger AG, Basel.

  5. The use of nanoencapsulation to decrease human skin irritation caused by capsaicinoids

    PubMed Central

    Contri, Renata V; Frank, Luiza A; Kaiser, Moacir; Pohlmann, Adriana R; Guterres, Silvia S

    2014-01-01

    Capsaicin, a topical analgesic used in the treatment of chronic pain, has irritant properties that frequently interrupt its use. In this work, the effect of nanoencapsulation of the main capsaicinoids (capsaicin and dihydrocapsaicin) on skin irritation was tested in humans. Skin tolerance of a novel vehicle composed of chitosan hydrogel containing nonloaded nanocapsules (CH-NC) was also evaluated. The chitosan hydrogel containing nanoencapsulated capsaicinoids (CH-NC-CP) did not cause skin irritation, as measured by an erythema probe and on a visual scale, while a formulation containing free capsaicinoids (chitosan gel with hydroalcoholic solution [CH-ET-CP]) and a commercially available capsaicinoids formulation caused skin irritation. Thirty-one percent of volunteers reported slight irritation one hour after application of CH-NC-CP, while moderate (46% [CH-ET-CP] and 23% [commercial product]) and severe (8% [CH-ET-CP] and 69% [commercial product]) irritation were described for the formulations containing free capsaicinoids. When CH-NC was applied to the skin, erythema was not observed and only 8% of volunteers felt slight irritation, which demonstrates the utility of the novel vehicle. A complementary in vitro skin permeation study showed that permeation of capsaicinoids through an epidermal human membrane was reduced but not prevented by nanoencapsulation. PMID:24611011

  6. A retrospective analysis of in vivo eye irritation, skin irritation and skin sensitisation studies with agrochemical formulations: Setting the scene for development of alternative strategies.

    PubMed

    Corvaro, M; Gehen, S; Andrews, K; Chatfield, R; Macleod, F; Mehta, J

    2017-10-01

    Analysis of the prevalence of health effects in large scale databases is key in defining testing strategies within the context of Integrated Approaches on Testing and Assessment (IATA), and is relevant to drive policy changes in existing regulatory toxicology frameworks towards non-animal approaches. A retrospective analysis of existing results from in vivo skin irritation, eye irritation, and skin sensitisation studies on a database of 223 agrochemical formulations is herein published. For skin or eye effects, high prevalence of mild to non-irritant formulations (i.e. per GHS, CLP or EPA classification) would generally suggest a bottom-up approach. Severity of erythema or corneal opacity, for skinor eye effects respectively, were the key drivers for classification, consistent with existing literature. The reciprocal predictivity of skin versus eye irritation and the good negative predictivity of the GHS additivity calculation approach (>85%) provided valuable non-testing evidence for irritation endpoints. For dermal sensitisation, concordance on data from three different methods confirmed the high false negative rate for the Buehler method in this product class. These results have been reviewed together with existing literature on the use of in vitro alternatives for agrochemical formulations, to propose improvements to current regulatory strategies and to identify further research needs. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Skin irritation, false positives and the local lymph node assay: a guideline issue?

    PubMed

    Basketter, David A; Kimber, Ian

    2011-10-01

    Since the formal validation and regulatory acceptance of the local lymph node assay (LLNA) there have been commentaries suggesting that the irritant properties of substances can give rise to false positives. As toxicology aspires to progress rapidly towards the age of in vitro alternatives, it is of increasing importance that issues relating to assay selectivity and performance are understood fully, and that true false positive responses are distinguished clearly from those that are simply unpalatable. In the present review, we have focused on whether skin irritation per se is actually a direct cause of true false positive results in the LLNA. The body of published work has been examined critically and considered in relation to our current understanding of the mechanisms of skin irritation and skin sensitisation. From these analyses it is very clear that, of itself, skin irritation is not a cause of false positive results. The corollary is, therefore, that limiting test concentrations in the LLNA for the purpose of avoiding skin irritation may lead, unintentionally, to false negatives. Where a substance is a true false positive in the LLNA, the classic example being sodium lauryl sulphate, explanations for that positivity will have to reach beyond the seductive, but incorrect, recourse to its skin irritation potential. Copyright © 2011 Elsevier Inc. All rights reserved.

  8. Tandem Repeated Irritation Test (TRIT) Studies and Clinical Relevance: Post 2006.

    PubMed

    Reddy, Rasika; Maibach, Howard

    2018-06-11

    Single or multiple applications of irritants can lead to occupational contact dermatitis, and most commonly irritant contact dermatitis (ICD). Tandem irritation, the sequential application of two irritants to a target skin area, has been studied using the Tandem Repeated Irritation Test (TRIT) to provide a more accurate representation of skin irritation. Here we present an update to Kartono's review on tandem irritation studies since 2006 [1]. We surveyed the literature available on PubMed, Embase, Google Scholar, and the UCSF Dermatology library databases since 2006. The studies included discuss the tandem effects of common chemical irritants, organic solvents, occlusion as well as clinical relevance - and enlarge our ability to discern whether multiple chemical exposures are more or less likely to enhance irritation.

  9. Skin and Eye Irritation Assessment of Oil Palm ( Elaeis guineensis) Leaf Extract for Topical Application.

    PubMed

    Yusof, Nor Zuliana; Abd Gani, Siti Salwa; Azizul Hasan, Zafarizal Aldrin; Idris, Zainab

    2018-01-01

    Many types of phytochemicals have been found to be present in oil palm leaf and could potentially be used as functional ingredients for skincare product. However, as of today, there is no published report on hazard identification and safety assessment of oil palm ( Elaeis guineensis) leaf extract (OPLE), particularly on skin and eye irritation. In this study, potential hazard of OPLE on skin and eye irritation was evaluated as an initial step to the safety assessment of OPLE. In vitro cell viability study of OPLE on normal human dermal fibroblasts showed that OPLE was nontoxic to the cells with percentage viability more than 90% after 24 and 48 hours of incubation. Skin irritation potential of OPLE was evaluated using in vitro SkinEthic reconstructed human epidermis (RHE) model (Organization for Economic Cooperation and Development [OECD] Test Guideline 439, 2015), while eye irritation potential was evaluated using in vitro SkinEthic Human corneal epithelium (HCE) model (OECD test guideline 492, 2017). Hazard identification results showed that OPLE at 1%, 5%, and 10% (wt/wt) was classified as nonirritant to the skin and eye where mean tissue viabilities of SkinEthic RHE and SkinEthic HCE were more than 50% and 60%, respectively. Therefore, we recommend a further safety assessment, such as human patch testing, to confirm the nonirritant of OPLE.

  10. A study of the relationship between susceptibility to skin stinging and skin irritation.

    PubMed

    Basketter, D A; Griffiths, H A

    1993-10-01

    In an evaluation of the safety of new chemicals, of products containing them, or of novel formulations of existing chemicals which may come into contact with the skin, it is important to incorporate an assessment of specially susceptible sub-populations. Such a group is represented by those who are more likely to experience sensory effects such as stinging. Since these individuals are easily and rapidly identifiable, we investigated whether they represented a group who were also more susceptible to the effects of an irritant. The primary purpose was to discover whether 'stingers' might represent an easily and rapidly identifiable sub-population with a more generally increased tendency to give skin responses. The response to a 0.3% sodium dodecyl sulphate patch test was assessed in a group of 25 'stingers' and compared to the response in 25 'non-stingers'. There was no difference in either the pattern or strength of the irritant response assessed by subjective erythema and dryness scores. Thus the data suggest that there is no correlation between the susceptibility of an individual to a skin stinging response and an irritation reaction.

  11. Genotoxicity, acute oral and dermal toxicity, eye and dermal irritation and corrosion and skin sensitisation evaluation of silver nanoparticles.

    PubMed

    Kim, Jin Sik; Song, Kyung Seuk; Sung, Jae Hyuck; Ryu, Hyun Ryol; Choi, Byung Gil; Cho, Hyun Sun; Lee, Jin Kyu; Yu, Il Je

    2013-08-01

    To clarify the health risks related to silver nanoparticles (Ag-NPs), we evaluated the genotoxicity, acute oral and dermal toxicity, eye irritation, dermal irritation and corrosion and skin sensitisation of commercially manufactured Ag-NPs according to the OECD test guidelines and GLP. The Ag-NPs were not found to induce genotoxicity in a bacterial reverse mutation test and chromosomal aberration test, although some cytotoxicity was observed. In acute oral and dermal toxicity tests using rats, none of the rats showed any abnormal signs or mortality at a dose level of ∼ 2000 mg/kg. Similarly, acute eye and dermal irritation and corrosion tests using rabbits revealed no significant clinical signs or mortality and no acute irritation or corrosion reaction for the eyes and skin. In a skin sensitisation test using guinea pigs, one animal (1/20) showed discrete or patchy erythema, thus Ag-NPs can be classified as a weak skin sensitiser.

  12. Stratum corneum cytokines and skin irritation response to sodium lauryl sulfate.

    PubMed

    De Jongh, Cindy M; Verberk, Maarten M; Withagen, Carien E T; Jacobs, John J L; Rustemeyer, Thomas; Kezic, Sanja

    2006-06-01

    Little is known about cytokines involved in chronic irritant contact dermatitis. Individual cytokine profiles might explain at least part of the differences in the individual response to irritation. Our objective was to investigate the relation between baseline stratum corneum (SC) cytokine levels and the skin response to a single and a repeated irritation test. This study also aimed to determine changes in SC cytokine levels after repeated irritation. Transepidermal water loss (TEWL) and erythema were measured in 20 volunteers after single 24-hr exposure to 1% sodium lauryl sulfate (SLS), and during and after repeated exposure to 0.1% SLS over a 3-week period. SC cytokine levels were measured from an unexposed skin site and from the repeatedly exposed site. Interleukin (IL)-1alpha decreased by 30% after repeated exposure, while IL-1RA increased 10-fold and IL-8 increased fourfold. Baseline IL-1RA and IL-8 values were predictors of TEWL and erythema after single exposure (r = 0.55-0.61). 6 subjects showed barrier recovery during repeated exposure. Baseline IL-1RA and IL-8 levels are likely to be indicators of higher skin irritability after single exposure to SLS. Barrier repair in some of the subjects might explain the lack of agreement between the TEWL response after single and repeated irritation.

  13. Food patch testing for irritable bowel syndrome.

    PubMed

    Stierstorfer, Michael B; Sha, Christopher T; Sasson, Marvin

    2013-03-01

    The traditional classification of irritable bowel syndrome (IBS) as a functional disorder has been challenged in recent years by evidence of ongoing low-grade gastrointestinal tract inflammation. Inflammation may alter gastrointestinal motility and thus be central to the pathogenesis of IBS. Many foods and food additives are known to cause allergic contact dermatitis. We hypothesize that allergenic foods and food additives may elicit a similar allergic reaction in the gastrointestinal tract, giving rise to symptoms suggestive of IBS. We sought to determine whether skin patch testing to a panel of foods and food additives may identify food allergens that may be responsible for symptoms of IBS. We performed skin patch testing to common allergenic foods and food additives on individuals with a history of or symptoms suggestive of IBS. We used patch test-guided avoidance diets to determine whether avoidance alleviates IBS symptoms. Thirty of the 51 study participants showed at least 1 doubtful or positive patch test result. Fourteen of the participants reported symptomatic improvement, ranging from slight to great, upon avoidance of the foods/food additives to which they reacted. Double-blind study design, inclusion of only patients with active IBS, larger sample size, more balanced gender distribution, testing of more foods/food additives, and longer duration of and more precise quantification of response to dietary avoidance are suggested for future studies. Allergic contact enteritis to ingested foods, food additives, or both may contribute to IBS symptoms. Patch testing may be useful in identifying the causative foods. Copyright © 2012 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  14. Ethnic differences in objective and subjective skin irritation response: an international study.

    PubMed

    Lee, E; Kim, S; Lee, J; Cho, S-A; Shin, K

    2014-08-01

    Due to global marketing in the cosmetics industry, it is important to assess ethnic population susceptibility when evaluating the safety of cosmetic products or chemicals. To investigate ethnic variations in skin irritation response to positive irritants. Clinical testing was performed in four countries on two ethnic groups - Asian and Caucasian. We performed patch tests on the subjects' back with 0.5% aqueous sodium lauryl sulfate (SLS) and 0.15% retinol prepared in 1,3-butylene glycol. Stinging tests were performed using 5% aqueous lactic acid and 0.001% (w/v) capsaicin prepared in 10% ethanol solution separately. The incidence of self-perceived skin sensitivity was similar in the two ethnic groups. However, the incidence of adverse skin reaction to cosmetics appeared significantly higher in Asian (33.0%) than in Caucasian subjects (11.3%). For standard positive irritants such as 0.5% aqueous SLS solution, Asian subjects showed significantly higher scores than Caucasian subjects. The incidence of positive reaction to the 0.15% retinol patch test tended to be higher in Asian than in Caucasian subjects. Our data also showed that neurosensitivity to 5% lactic acid and 0.001% capsaicin was higher in Asian than in Caucasian subjects. Although self-reported skin sensitivity does not appear to differ according to ethnicity, there are ethnic differences in objective and subjective skin irritation responses to several standard positive materials. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Experimental study on skin irritation of bone spur powder on rabbit

    NASA Astrophysics Data System (ADS)

    Ma, Zhenzhen; Zhang, Xuhui; Hao, Shaojun; Shen, Huiling; Wang, Huamin; Ji, Xianghui; Zhang, Zhengchen; Huang, Youling

    2018-04-01

    To observe the effect of bone powder of rabbit skin, provide the basis for the safety of clinical use of bone powder, 24 rabbits were randomly divided into 6 groups, complete skin test and damaged skin test each divided into 3 groups (n=4), high, low, 3 doses tested daily administered 1 times, continuous administration for 7 days, in 24 hours after the last administration of drug residues, wash with warm water, the removal of L hours after drug for 24 hours, 48 hours, 72 hours and seventh days, observed and recorded to apply position before administration and administration during the skin no erythema and edema, and observe the smear Parts of any pigmentation, bleeding, rough skin or thin skin etc., record the occurrence time and duration time. Through comparative observation, intact skin group before administration and dosing period, there were no erythema and edema, pigmentation, bleeding, rough skin or thin skin etc., there is no difference with the control group; the damaged skin group after administration of 1 to 5 days, each rabbit skin there are different degrees of erythema and edema, especially to skin injury after 24-48 hours is obvious, 2 days (48 hours) after 4 days gradually reduced, significantly subsided after 6 days, erythema and edema phenomenon subsided completely, not out of blood, pigmentation, rough skin or thin skin and so on. The bone spur powder has no irritation on the intact skin of rabbits. The bone spur powder has moderate irritation on the damaged skin of rabbits, but after 48 hours, the stimulation reaction subsided spontaneously, which is caused by the inflammatory reaction caused by skin injury, rather than the medication. The bone spur powder is safe for clinical use.

  16. Dexpanthenol enhances skin barrier repair and reduces inflammation after sodium lauryl sulphate-induced irritation.

    PubMed

    Proksch, E; Nissen, H P

    2002-12-01

    Dexpanthenol-containing creams have been widely used for treatment of lesions (superficial wounds) of the skin and mucous membranes. Dexpanthenol is converted in tissues to pantothenic acid, a component of coenzyme A. Coenzyme A catalyses early steps in the synthesis of fatty acids and sphingolipids which are of crucial importance for stratum corneum lipid bilayers and cell membrane integrity. In the present study, the effects were examined of a dexpanthenol-containing cream on skin barrier repair, stratum corneum hydration, skin roughness, and inflammation after sodium lauryl sulphate (SLS)-induced irritation. Irritation was induced by application of SLS in patch test chambers. The dexpanthenol-contaming cream or the vehicle were applied twice daily and barrier repair, hydration, roughness, and inflammation of the skin were determined by using biophysical methods. Significantly accelerated skin barrier repair was found in treatments with the dexpanthenol-containing cream (verum) compared with vehicle-treated (placebo) or untreated skin. Both verum and placebo showed an increase in stratum corneum hydration, but significantly more so with the dexpanthenol-containing cream. Both creams reduced skin roughness, but again the verum was superior. The dexpanthenol-containing cream significantly reduced skin redness as a sign of inflammation in contrast to the vehicle, which produced no effect. Treatment with a dexpanthenol-containing cream showed significantly enhanced skin barrier repair and stratum corneum hydration, while reducing skin roughness and inflammation.

  17. Evaluation of the skin irritation using a DNA microarray on a reconstructed human epidermal model.

    PubMed

    Niwa, Makoto; Nagai, Kanji; Oike, Hideaki; Kobori, Masuko

    2009-02-01

    To avoid the need to use animals to test the skin irritancy potential of chemicals and cosmetics, it is important to establish an in vitro method based on the reconstructed human epidermal model. To evaluate skin irritancy efficiently and sensitively, we determined the gene expression induced by a topically-applied mild irritant sodium dodecyl sulfate (SDS) in a reconstructed human epidermal model LabCyte EPI-MODEL (LabCyte) using a DNA microarray carrying genes that were related to inflammation, immunity, stress and housekeeping. The expression and secretion of IL-1alpha in reconstructed human epidermal culture is known to be induced by irritation. We detected the induction of IL-1alpha expression and its secretion into the cell culture medium by treatment with 0.075% SDS for 18 h in LabCyte culture using DNA microarray, quantitative reverse-transcription polymerase chain reaction (RT-PCR) and ELISA. DNA microarray analysis indicated that the expression of 10 of the 205 genes carried on the DNA microarray was significantly induced in a LabCyte culture by 0.05% or 0.075% SDS irritation for 18 h. RT-PCR analysis confirmed that SDS treatment significantly induced the expressions of interleukin-1 receptor antagonist (IL-1RN), FOS-like antigen 1 (FOSL1), heat shock 70 kDa protein 1A (HSPA1) and myeloid differentiation primary response gene (88) (MYD88), as well as the known marker genes for irritation IL-1beta and IL-8 in a LabCyte culture. Our results showed that a DNA microarray is a useful tool for efficiently evaluating mild skin irritation using a reconstructed human epidermal model.

  18. In vitro assessment of skin irritation potential of surfactant-based formulations by using a 3-D skin reconstructed tissue model and cytokine response.

    PubMed

    Walters, Russel M; Gandolfi, Lisa; Mack, M Catherine; Fevola, Michael; Martin, Katharine; Hamilton, Mathew T; Hilberer, Allison; Barnes, Nicole; Wilt, Nathan; Nash, Jennifer R; Raabe, Hans A; Costin, Gertrude-Emilia

    2016-12-01

    The personal care industry is focused on developing safe, more efficacious, and increasingly milder products, that are routinely undergoing preclinical and clinical testing before becoming available for consumer use on skin. In vitro systems based on skin reconstructed equivalents are now established for the preclinical assessment of product irritation potential and as alternative testing methods to the classic Draize rabbit skin irritation test. We have used the 3-D EpiDerm™ model system to evaluate tissue viability and primary cytokine interleukin-1α release as a way to evaluate the potential dermal irritation of 224 non-ionic, amphoteric and/or anionic surfactant-containing formulations, or individual raw materials. As part of our testing programme, two representative benchmark materials with known clinical skin irritation potential were qualified through repeated testing, for use as references for the skin irritation evaluation of formulations containing new surfactant ingredients. We have established a correlation between the in vitro screening approach and clinical testing, and are continually expanding our database to enhance this correlation. This testing programme integrates the efforts of global manufacturers of personal care products that focus on the development of increasingly milder formulations to be applied to the skin, without the use of animal testing. 2016 FRAME.

  19. Long-term repetitive sodium lauryl sulfate-induced irritation of the skin: an in vivo study.

    PubMed

    Branco, Nara; Lee, Ivy; Zhai, Hongbo; Maibach, Howard I

    2005-11-01

    Skin may adapt to topical irritants through accommodation. This study focuses on long-term exposure to irritants and attempts to demonstrate accommodation. Sodium lauryl sulfate (SLS) induced irritant contact dermatitis at 3 concentrations (0.025% to 0.075%). Distilled water, acetone and an empty chamber served as controls. Experimental compounds were applied to forearms of 7 healthy volunteers for 24 hr before replacing by a fresh chamber for 6 non-consecutive weeks over 103 days. Possible accommodation was quantified by visual scoring (erythema and dryness) and by bioengineering parameters: transepidermal water loss (TEWL), capacitance, chromametry and laser Doppler flowmetry (LDF). Significant erythema, dryness, elevated TEWL, skin colour reflectance and LDF values occurred during the exposure periods. Upon repeat exposure, an immediate and augmented response in erythema, TEWL, skin colour reflectance and LDF developed. However, irritant skin changes were not sustained. Irritation parameters return to baseline after cessation of exposure. There was no evidence of sustained irritation or accommodation after the last exposure. Study findings do not document sustained accommodation or adaptive hyposensitivity after long-term repetitive irritant exposure under these test conditions. Alternative models should be developed to prove or disprove the accommodation hypothesis.

  20. [Changes of nitric oxide after trichloroethylene irritation in hairless mice skin and protection of ginkgo biloba extract and vitamin E].

    PubMed

    Wang, Liang; Shen, Tong; Zhou, Cheng-fan; Yu, Jun-feng; Zhu, Qi-xing

    2009-04-01

    To study the changes of nitric oxide (NO) in the BALB/c hairless mice skin after trichloroethylene (TCE) irritation and the protection of ginkgo biloba extract (GbE) and vitamin E (VE). 132 BALB/c hairless mice were randomly divided into blank control group, solvent group (olive oil), TCE groups (20%TCE, 40%TCE, 80%TCE and 100%TCE), GbE groups (0.1%GbE, 1%GbE and 10%GbE) and VE groups (5%VE, 10% VE and 20% VE), with 11 animals in each group, 5 for acute irritation test and 6 for the cumulative irritation test. The skin irritation was observed, and the levels of NO in the dorsal skin of BALB/C hairless mice were detected. The kit of NO was used to detect the levels of NO in the dorsal skin of BALB/c hairless mice. (1) The skin presented erythema and edema after TCE irritation both in acute irritation and cumulative irritation test and the skin inflammation showed time-dose effect relationship; the mice skin was protected in GbE or VE groups. (2) In the acute stimulation test, the levels of NO in 80%TCE group (69.895 +/- 9.605 micromol/mg pro) and 100%TCE group (77.273 +/- 9.290 micromol/mg pro) were significantly different compared with blank control group and solvent control group (P < 0.05 or P < 0.01). In the protection group, the NO level were reduced, with the statistically significant differences. (3) In acute irritation test, the levels of NO in 80%TCE group (60.362 +/- 9.817 micromol/mg pro) and 100%TCE group (68.027 +/- 9.354 micromol/mg pro) were significantly different compared with blank control group and solvent control group, (P < 0.05 or P < 0.01); In the protection group, 1% GbE, 10% GbE, 10% VE and 20%VE could reduce the levels of NO, with statistically significant differences. TCE can produce the irritation on the dorsal skin of BALB/c hairless mice and induce the significant increase of the NO levels. GbE and VE can protect the skin from TCE irritation damage.

  1. Hydrophobically modified polymers can minimize skin irritation potential caused by surfactant-based cleansers.

    PubMed

    Draelos, Zoe; Hornby, Sidney; Walters, Russel M; Appa, Yohini

    2013-12-01

    The addition of hydrophobically modified polymers (HMPs) to cleansers that contain surfactants can create polymer-surfactant complexes that are less irritating to the skin than commercially available mild cleansers. Our objective was to compare the tolerability and efficacy of a test foaming liquid facial cleanser containing HMPs with a commercial liquid nonfoaming facial cleanser in women with sensitive skin. In this randomized, prospective, double-blind, comparative study, women (n = 20 per group) with mild-to-moderate atopic dermatitis (AD), eczema, acne, or rosacea used a test gentle foaming liquid facial cleanser containing HMPs or a commercial gentle liquid nonfoaming facial cleanser daily for 3 weeks. Investigators assessed irritation and skin condition. Study subjects also assessed their skin properties and the performance of each cleanser. Clinicians as well as study subjects consistently rated the test cleanser as effective or slightly more effective at improving symptoms than the commercial cleanser, although no significant differences between groups were observed. At weeks 1 and 3, respectively, more users of the commercial cleanser reported irritation (20% and 10%) than users of the test cleanser (5% and 5%). In addition, subject self-assessments of skin condition and cleansing properties were slightly more improved with the test cleanser than with the commercial cleanser. Both the test foaming cleanser containing HMPs and the commercial nonfoaming cleanser were effective and well accepted by most women in the study. Improvements were observed by both clinicians and subjects in the group using the test cleanser containing HMPs in all evaluated skin categories. © 2013 The Authors Journal of Cosmetic Dermatology Published by Wiley Periodicals, Inc.

  2. [Development of alternative to animal experiment in evaluation of skin irritation caused by alcohol-based hand rubs].

    PubMed

    Yamamoto, Nobuyuki; Miyamoto, Koji; Katoh, Masakazu

    2010-08-01

    Alcohol-based hand rubs are widely used for infection control in clinical practice. However, it is known that frequent use of the alcohol-based hand rubs may cause skin irritation. To predict the skin irritation in human, animal experiments are quite useful. Especially, the Draize Test using rabbits is suitable for this purpose because their skin is highly sensitive. On the other hand, the development of alternative to animal experiments is important not only from the viewpoint of ethical aspects but also from the efficient research and development. Reconstructed human epidermis (RhE) was developed as a human skin equivalent model in vitro, and has been applied to the evaluation of skin irritation. But the RhE has not been utilized for the evaluation of alcohol-based hand rubs because of the high skin permeability and cytotoxicity of alcohols. The aim of this study was to develop a new method using the RhE in evaluation of skin irritation caused by alcohol-based hand rubs. The authors propose an experimental technique named "Skin model blowing method (SMBM)" consisting of the sequential procedure as follows; applying small amount of testing sample on RhE, blow-dry, post incubation, and cell viability measurement. According to the SMBM, the skin irritation caused by alcohol-based hand rubs could be evaluated under the similar condition of their actual use. It was found that a high correlation existed between the cell viability obtained from SMBM and the skin irritation index in rabbit which had been reported previously.

  3. Dicationic Alkylammonium Bromide Gemini Surfactants. Membrane Perturbation and Skin Irritation

    PubMed Central

    Almeida, João A. S.; Faneca, Henrique; Carvalho, Rui A.; Marques, Eduardo F.; Pais, Alberto A. C. C.

    2011-01-01

    Dicationic alkylammonium bromide gemini surfactants represent a class of amphiphiles potentially effective as skin permeation enhancers. However, only a limited number of studies has been dedicated to the evaluation of the respective cytotoxicity, and none directed to skin irritation endpoints. Supported on a cell viability study, the cytotoxicity of gemini surfactants of variable tail and spacer length was assessed. For this purpose, keratinocyte cells from human skin (NCTC 2544 cell line), frequently used as a model for skin irritation, were employed. The impact of the different gemini surfactants on the permeability and morphology of model vesicles was additionally investigated by measuring the leakage of calcein fluorescent dye and analyzing the NMR spectra of 31P, respectively. Detail on the interaction of gemini molecules with model membranes was also provided by a systematic differential scanning calorimetry (DSC) and molecular dynamics (MD) simulation. An irreversible impact on the viability of the NCTC 2544 cell line was observed for gemini concentrations higher than 25 mM, while no cytotoxicity was found for any of the surfactants in a concentration range up to 10 mM. A higher cytotoxicity was also found for gemini surfactants presenting longer spacer and shorter tails. The same trend was obtained in the calorimetric and permeability studies, with the gemini of longest spacer promoting the highest degree of membrane destabilization. Additional structural and dynamical characterization of the various systems, obtained by 31P NMR and MD, provide some insight on the relationship between the architecture of gemini surfactants and the respective perturbation mechanism. PMID:22102870

  4. 16 CFR 1500.42 - Test for eye irritants.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Test for eye irritants. 1500.42 Section 1500... eye irritants. (a)(1) Six albino rabbits are used for each test substance. Animal facilities for such... materials that might produce eye irritation. Both eyes of each animal in the test group shall be examined...

  5. Assessment of Irritation and Sensitization Potential of Eight Baby Skin Care Products.

    PubMed

    Galzote, Carlos; Thomas, Mini; Sachdev, Mukta

    2016-10-01

    Ethnic differences in skin sensitivity suggest that greater emphasis be focused on understanding a product's effect in diverse populations. The irritation and/or sensitization potential of 8 baby skin care products in Indian adults were evaluated using cumulative irritation tests (CIT) and human repeat insult patch testing (HRIPT) protocols. Healthy males or females aged 18 to 65 years of Indian ethnicity were treated with each of 6 products (cream, hair oil, lotion, body wash, shampoo, and baby soap) using CIT (n = 25) and HRIPT (n = 200). Baby powder and baby oil were evaluated by CIT (n = 25) and HRIPT (n = 107) in separate studies. CITs were conducted over 14 days; HRIPTs were conducted over 10 weeks. In both CIT and HRIPT, most products were considered mild, with no irritation. Baby soap and powder elicited reactions in the HRIPT induction phase, with positive challenge phase reactions (3 subjects), but were affirmed to be nonallergenic in the rechallenge phase. In these studies, 8 baby skin care products were evaluated by both CIT and HRIPT in Indian adults. The results of the studies indicated that all of the tested products were nonallergenic and nonirritating.

    J Drugs Dermatol. 2016;15(10):1244-1248.

  6. Toxicity evaluation of the photoprotective compound LQFM048: Eye irritation, skin toxicity and genotoxic endpoints.

    PubMed

    de Ávila, Renato Ivan; de Sousa Vieira, Marcelo; Gaeti, Marilisa Pedroso Nogueira; Moreira, Larissa Cleres; de Brito Rodrigues, Laís; de Oliveira, Gisele Augusto Rodrigues; Batista, Aline Carvalho; Vinhal, Daniela Cristina; Menegatti, Ricardo; Valadares, Marize Campos

    2017-02-01

    A new molecule, LQFM048, originally designed through molecular hybridization using green chemistry approach, is in development as a photoprotective agent. Eye irritation, skin toxicity and genotoxicity evaluations are mandatory for predicting health risks. In this context, the purpose of this study was to investigate the eye irritation potential of LQFM048 by combining Short Time Exposure (STE), Bovine Corneal Opacity and Permeability (BCOP) associated with corneal histomorphometry and Hen's Egg Test-Chorioallantoic Membrane (HET-CAM). Additionally, skin toxicity was evaluated by interleukin-18 production in the HaCaT keratinocyte, Local Lymph Node Assay (LLNA:BrdU-ELISA) method, 3T3 Neutral red uptake (NRU) assay and in vivo phototoxicity test. Genotoxic potential of LQFM048 was also analyzed by cytokinesis-block micronucleus assay (MNvit test-cytoB) in HepG2 cells. Our results showed that LQFM048 did not induce eye irritation and it was classified as UN GHS No Category for both STE and BCOP assays and non-irritating for HET-CAM test. LQFM048 showed non-potential skin sensitization with stimulation index (SI=0.7) in the LLNA:BrdU-ELISA method. Corroborating in vivo tests, it did not promote significant cytotoxicity in HaCaT cells and it showed similar levels of IL-18 when compared to control. Furthermore, LQFM048 induced non-phototoxic potential with photo-irritation factor (PIF) and mean photo effect (MPE) of 1 and -0.138, respectively, for 3T3 cells. Similarly, it was not phototoxic for in vivo testing with or without exposure to UVA, showing SI values of 1 and 1.2, respectively. The micronucleus test showed that LQFM048 was not genotoxic, under the conditions tested.In conclusion, LQFM048, a heterocyclic compound obtained through an environmentally acceptable simple synthetic route, seems to be safe for human use, especially for the development of a new sunscreen product, since it is neither an eye irritant, nor a contact allergen, nor mutagenic and nor

  7. Acute irritant threshold correlates with barrier function, skin hydration and contact hypersensitivity in atopic dermatitis and rosacea.

    PubMed

    Darlenski, Razvigor; Kazandjieva, Jana; Tsankov, Nikolai; Fluhr, Joachim W

    2013-11-01

    The aim of the study was to disclose interactions between epidermal barrier, skin irritation and sensitization in healthy and diseased skin. Transepidermal water loss (TEWL) and stratum corneum hydration (SCH) were assessed in adult patients with atopic dermatitis (AD), rosacea and healthy controls. A 4-h patch test with seven concentrations of sodium lauryl sulphate was performed to determine the irritant threshold (IT). Contact sensitization pattern was revealed by patch testing with European baseline series. Subjects with a lower IT had higher TEWL values and lower SCH. Subjects with positive allergic reactions had significantly lower IT. In AD, epidermal barrier deterioration was detected on both volar forearm and nasolabial fold, while in rosacea, impeded skin physiology parameters were observed on the facial skin only, suggesting that barrier impediment is restricted to the face in rosacea, in contrast with AD where the abnormal skin physiology is generalized. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  8. Histoplasma skin test

    MedlinePlus

    Histoplasmosis skin test ... health care provider cleans an area of your skin, usually the forearm. An allergen is injected just below the cleaned skin surface. An allergen is a substance that causes ...

  9. Assessment of phototoxicity, skin irritation, and sensitization potential of polystyrene and TiO2 nanoparticles

    NASA Astrophysics Data System (ADS)

    Park, Yoon-Hee; Jeong, Sang Hoon; Yi, Sang Min; Hyeok Choi, Byeong; Kim, Yu-Ri; Kim, In-Kyoung; Kim, Meyoung-Kon; Son, Sang Wook

    2011-07-01

    The human skin equivalent model (HSEM) is well known as an attractive alternative model for evaluation of dermal toxicity. However, only limited data are available on the usefulness of an HSEM for nanotoxicity testing. This study was designed to investigate cutaneous toxicity of polystyrene and TiO2 nanoparticles using cultured keratinocytes, an HSEM, and an animal model. In addition, we also evaluated the skin sensitization potential of nanoparticles using a local lymph node assay with incorporation of BrdU. Findings from the present study indicate that polystyrene and TiO2 nanoparticles do not induce phototoxicity, acute cutaneous irritation, or skin sensitization. Results from evaluation of the HSEMs correspond well with those from animal models. Our findings suggest that the HSEM might be a useful alternative model for evaluation of dermal nanotoxicity.

  10. PPD skin test

    MedlinePlus

    ... is a method used to diagnose silent (latent) tuberculosis (TB) infection. PPD stands for purified protein derivative. ... skin test; Tuberculin skin test; Mantoux test Images Tuberculosis in the kidney Tuberculosis in the lung Positive ...

  11. From topical antidote against skin irritants to a novel counter-irritating and anti-inflammatory peptide

    SciTech Connect

    Brodsky, Berta; Erlanger-Rosengarten, Avigail; Proscura, Elena

    2008-06-15

    The primary purpose of the present study was to investigate the mechanism of the counter-irritating activity of topical iodine against skin lesions induced by chemical and thermal stimuli. The hypothesis that iodine exerts its activity by inducing an endogenous anti-inflammatory factor was confirmed by exposing guinea pig skin to heat stimulus followed by topical iodine treatment and skin extraction. Injection of the extract into naive guinea pigs reduced heat-induced irritation by 69%. The protective factor, identified as a new nonapeptide (histone H2A 36-44, H-Lys-Gly-Asn-Tyr-Ala-Glu-Arg-Ileu-Ala-OH), caused reduction of 40% in irritation score in heat-exposed guinea pigs. The murine analog (H-Lys-Gly-His-Tyr-Ala-Glu-Arg-Val-Gly-OH, termedmore » IIIM1) reduced sulfur mustard (SM)-induced ear swelling at a dose-dependent bell-shape manner reaching peak activity of 1 mg/kg. Cultured keratinocytes transfected with the peptide were more resistant towards SM than the control cells. The peptide suppressed oxidative burst in activated neutrophils in a concentration-dependent manner. In addition, the peptide reduced glucose oxidase-induced skin edema in mice at a dose-dependent bell-shape manner. Apart from thermal and chemical-induced skin irritation this novel peptide might be of potential use in chronic dermal disorders such as psoriasis and pemphigus as well as non-dermal inflammatory diseases like multiple sclerosis, arthritis and colitis.« less

  12. Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment.

    PubMed

    Li, Chun-yu; Wang, Zhe-wei; Tu, Can; Wang, Jia-bo; Jiang, Bing-qian; Li, Qi; Zeng, Ling-na; Ma, Zhi-jie; Zhang, Ping; Zhao, Yan-ling; Zhang, Ya-ming; Yan, Dan; Tan, Rui; Xiao, Xiao-he

    2014-10-01

    Insulin is widely used in treating diabetes, but still needs to be administered by needle injection. This study investigated a new needle-free approach for insulin delivery. A portable powder needleless injection (PNI) device with an automatic mechanical unit was designed. Its efficiency in delivering insulin was evaluated in alloxan-induced diabetic rabbits. The skin irritation caused by the device was investigated and the results were analyzed in relation to aerodynamic parameters. Inorganic salt-carried insulin powders had hypoglycemic effects, while raw insulin powders were not effective when delivered by PNI, indicating that salt carriers play an important role in the delivery of insulin via PNI. The relative delivery efficiency of phosphate-carried insulin powder using the PNI device was 72.25%. A safety assessment test showed that three key factors (gas pressure, cylinder volume, and nozzle distance) were related to the amount of skin irritation caused by the PNI device. Optimized injection conditions caused minimal skin lesions and are safe to use in practice. The results suggest that PNI has promising prospects as a novel technology for delivering insulin and other biological drugs.

  13. Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment*

    PubMed Central

    Li, Chun-yu; Wang, Zhe-wei; Tu, Can; Wang, Jia-bo; Jiang, Bing-qian; Li, Qi; Zeng, Ling-na; Ma, Zhi-jie; Zhang, Ping; Zhao, Yan-ling; Zhang, Ya-ming; Yan, Dan; Tan, Rui; Xiao, Xiao-he

    2014-01-01

    Insulin is widely used in treating diabetes, but still needs to be administered by needle injection. This study investigated a new needle-free approach for insulin delivery. A portable powder needleless injection (PNI) device with an automatic mechanical unit was designed. Its efficiency in delivering insulin was evaluated in alloxan-induced diabetic rabbits. The skin irritation caused by the device was investigated and the results were analyzed in relation to aerodynamic parameters. Inorganic salt-carried insulin powders had hypoglycemic effects, while raw insulin powders were not effective when delivered by PNI, indicating that salt carriers play an important role in the delivery of insulin via PNI. The relative delivery efficiency of phosphate-carried insulin powder using the PNI device was 72.25%. A safety assessment test showed that three key factors (gas pressure, cylinder volume, and nozzle distance) were related to the amount of skin irritation caused by the PNI device. Optimized injection conditions caused minimal skin lesions and are safe to use in practice. The results suggest that PNI has promising prospects as a novel technology for delivering insulin and other biological drugs. PMID:25294378

  14. Effect of Skin Protection and Skin Irritation on the Internal Exposure to Carbon Disulfide in Employees of the Viscose Industry.

    PubMed

    Kilo, Sonja; Zonnur, Nina; Uter, Wolfgang; Göen, Thomas; Drexler, Hans

    2015-10-01

    Occupational exposure to carbon disulfide (CS2) leads to inhalative and dermal uptake and thereby to internal exposure. In order to prevent occupational contact dermatitis, gloves and skin protection creams are used at the workplace. The aim of the study was the evaluation of the influence of personal skin protection and irritation on the internal exposure to CS2 of employees in the viscose industry. One hundred and eighty-two male CS2-exposed employees were included in the study and were examined regarding working conditions, use of personal protective measures und skin status. Personal air monitoring and biological monitoring was performed and the 'relative internal exposure' (RIE, internal exposure in relation to external exposure) calculated. A multiple regression analysis calculated the influence of skin protection and irritation on CS2 uptake. Usage of skin protection creams and gloves (and both in combination) while working was associated with a significantly higher RIE indicating a higher dermal penetration of CS2. Equally, irritated skin and younger age was associated with a higher internal burden. Gloves and skin protection creams are useful for preventing occupational skin diseases. However, when handling skin-resorptive substances like CS2, they can increase internal exposure or skin irritation. Therefore, we recommend the careful consideration of benefits and risks of protective creams and gloves at the workplace. © The Author 2015. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

  15. Do local meteorological conditions influence skin irritation caused by transdermal rivastigmine? A retroprospective, pilot study.

    PubMed

    Segers, Kurt; Cytryn, Ephraim; Surquin, Murielle

    2012-06-01

    This retrospective study aimed to evaluate the incidence of transdermal rivastigmine treatment withdrawal secondary to adverse skin reactions among the patients from our Memory Clinic. In addition, we tested whether climatic conditions might have an influence on skin irritations leading to eventual treatment disruption. We performed a retrospective review of patients from the Brugmann University Hospital Memory Clinic having started transdermal rivastigmine between June 2008 and December 2010. Local meteorological data were provided by the Royal Meteorological Institute of Belgium. A total of 26.9% of the patients experienced adverse skin reactions at the rivastigmine application site, leading to treatment discontinuation in 19.2% of the cases. Rivastigmine cutaneous tolerability was not found to be related to demographic parameters, Mini Mental Status Examination score, or type of dementia. High temperature and low air humidity during the first month of treatment were found to be associated with a higher incidence of skin reactions and secondary treatment disruption. Transdermal rivastigmine induced a higher incidence of cutaneous adverse events than previously reported in a prospective clinical trial. Moreover, it seems that meteorological conditions favoring skin perspiration (high temperature and low air humidity) during the first month of treatment might have an influence on transdermal rivastigmine skin tolerability.

  16. Kinetic analysis on the skin disposition of cytotoxicity as an index of skin irritation produced by cetylpyridinium chloride: comparison of in vitro data using a three-dimensional cultured human skin model with in vivo results in hairless mice.

    PubMed

    Kano, Satoshi; Sugibayashi, Kenji

    2006-02-01

    The aim of this study was to kinetically and dynamically analyze in vitro cytotoxicity as an index of skin irritation by use of a three-dimensional cultured human skin model and to compare the in vitro assay data with data from living animals. A cationic surfactant, cetylpyridinium chloride (CPC), was selected as a model irritant. Living skin equivalent-high (LSE-high) and hairless mice were used for the in vitro and in vivo tests, respectively. Skin irritation dermatodynamics was evaluated by calorimetric thiazoyl blue (MTT) conversion assay both for in vitro and in vivo tests, whereas dermatokinetics of CPC in LSE-high and mouse skin were evaluated using HPLC. The time course of cell viability in the skin after application of CPC to intact skin was distinctly different from that of stratum-corneum-stripped skin in both LSE-high and hairless mice. Biphasic behavior characterized by two first-order rates with an inflection time point was observed in intact skin, whereas cell viability monoexponentially decreased immediately after CPC application in stripped skin. The time courses of cell viability in the skin and dermatodynamics were closely related to that of dermatokinetics of CPC. The present study demonstrates that the in vitro cytotoxic profile was similar to the in vivo cytotoxicity test and that dermatodynamics was related to dermatokinetics of CPC.

  17. Breath tests and irritable bowel syndrome

    PubMed Central

    Rana, Satya Vati; Malik, Aastha

    2014-01-01

    Breath tests are non-invasive tests and can detect H2 and CH4 gases which are produced by bacterial fermentation of unabsorbed intestinal carbohydrate and are excreted in the breath. These tests are used in the diagnosis of carbohydrate malabsorption, small intestinal bacterial overgrowth, and for measuring the orocecal transit time. Malabsorption of carbohydrates is a key trigger of irritable bowel syndrome (IBS)-type symptoms such as diarrhea and/or constipation, bloating, excess flatulence, headaches and lack of energy. Abdominal bloating is a common nonspecific symptom which can negatively impact quality of life. It may reflect dietary imbalance, such as excess fiber intake, or may be a manifestation of IBS. However, bloating may also represent small intestinal bacterial overgrowth. Patients with persistent symptoms of abdominal bloating and distension despite dietary interventions should be referred for H2 breath testing to determine the presence or absence of bacterial overgrowth. If bacterial overgrowth is identified, patients are typically treated with antibiotics. Evaluation of IBS generally includes testing of other disorders that cause similar symptoms. Carbohydrate malabsorption (lactose, fructose, sorbitol) can cause abdominal fullness, bloating, nausea, abdominal pain, flatulence, and diarrhea, which are similar to the symptoms of IBS. However, it is unclear if these digestive disorders contribute to or cause the symptoms of IBS. Research studies show that a proper diagnosis and effective dietary intervention significantly reduces the severity and frequency of gastrointestinal symptoms in IBS. Thus, diagnosis of malabsorption of these carbohydrates in IBS using a breath test is very important to guide the clinician in the proper treatment of IBS patients. PMID:24976698

  18. MUTZ-3 derived Langerhans cells in human skin equivalents show differential migration and phenotypic plasticity after allergen or irritant exposure

    SciTech Connect

    Kosten, Ilona J.; Spiekstra, Sander W.; Gruijl, Tanja D. de

    After allergen or irritant exposure, Langerhans cells (LC) undergo phenotypic changes and exit the epidermis. In this study we describe the unique ability of MUTZ-3 derived Langerhans cells (MUTZ-LC) to display similar phenotypic plasticity as their primary counterparts when incorporated into a physiologically relevant full-thickness skin equivalent model (SE-LC). We describe differences and similarities in the mechanisms regulating LC migration and plasticity upon allergen or irritant exposure. The skin equivalent consisted of a reconstructed epidermis containing primary differentiated keratinocytes and CD1a{sup +} MUTZ-LC on a primary fibroblast-populated dermis. Skin equivalents were exposed to a panel of allergens and irritants. Topicalmore » exposure to sub-toxic concentrations of allergens (nickel sulfate, resorcinol, cinnamaldehyde) and irritants (Triton X-100, SDS, Tween 80) resulted in LC migration out of the epidermis and into the dermis. Neutralizing antibody to CXCL12 blocked allergen-induced migration, whereas anti-CCL5 blocked irritant-induced migration. In contrast to allergen exposure, irritant exposure resulted in cells within the dermis becoming CD1a{sup −}/CD14{sup +}/CD68{sup +} which is characteristic of a phenotypic switch of MUTZ-LC to a macrophage-like cell in the dermis. This phenotypic switch was blocked with anti-IL-10. Mechanisms previously identified as being involved in LC activation and migration in native human skin could thus be reproduced in the in vitro constructed skin equivalent model containing functional LC. This model therefore provides a unique and relevant research tool to study human LC biology in situ under controlled in vitro conditions, and will provide a powerful tool for hazard identification, testing novel therapeutics and identifying new drug targets. - Highlights: • MUTZ-3 derived Langerhans cells integrated into skin equivalents are fully functional. • Anti-CXCL12 blocks allergen-induced MUTZ-LC migration

  19. The effect of adhesive dressing edges on cutaneous irritancy and skin barrier function.

    PubMed

    Dykes, P J

    2007-03-01

    To assess the effect of repeated application and removal of adhesive edges from wound-care products on cutaneous irritancy and barrier function in normal volunteer subjects. This was a study using a 'repeat-insult patch test'. Adhesive edges from six commonly used wound-care products were applied continuously to the same site (six applications over a 14-day period) in 30 normal volunteer subjects. The test sites were assessed clinically before product reapplication using established ranking scales for cutaneous erythema. The cumulative irritancy score (CIS) for each test site was determined by adding the erythema scores at days 3, 5, 8, 10, 12 and 15. At the study end the barrier function of each test site was assessed by measuring transepidermal water loss (TEWL). The CIS showed that the products fall into two distinct groups, with Mepilex, Tielle and Allevyn giving low scores and Biatain, Comfeel and DuoDERM higher scores. Statistical analysis indicated significant differences (p < 0.05) between Mepilex and Biatain, Mepilex and Comfeel, Mepilex and DuoDERM, Tielle and Biatain, Allevyn and Biatain. The mean TEWL values also indicated that the products fall into two distinct groups: Mepilex, Tielle and Allevyn with low mean values close to that of normal adjacent back skin and Biatain, Comfeel and DuoDERM with much higher mean values. Statistical analysis indicated that Mepilex, Tielle and Allevyn were not significantly different from normal skin (p < 0.05), whereas Biatain, Comfeel and DuoDERM were significantly higher than normal skin and the other products tested. The results show clear differences between products; the clinical scores and TEWL measurements indicate that the products fall into two distinct groups. This novel approach seems able to discriminate between adhesive borders and may be useful during product development and in selecting products for clinical trials.

  20. IN VIVO EVALUATION OF SKIN IRRITATION POTENTIAL, MELASMA AND SEBUM CONTENT FOLLOWING LONG TERM APPLICATION OF SKIN CARE CREAM IN HEALTHY ADULTS, USING NON-INVASIVE BIOMETROLOGICAL TECHNIQUES.

    PubMed

    Arshad, Atif I; Khan, Shoaib H M; Akhtar, Naveed; Mahmood, Asif; Sarfraz, Rai Muhammad

    2016-01-01

    The present investigation was conducted to evaluate non-invasively, various functional skin parameters i.e., irritation potential, melasma and sebum contents following long term application of topical cream (w/o) loaded with 2% methanolic extract of Ananas comosus L. versus placebo control (base) in healthy adults. Healthy human volunteers (n = 11, aged 20-30 years) were recruited for investigation and written informed consent was taken from each volunteer. In this single blinded study every volunteer applied formulation on one side of face and placebo on the other side of face twice daily for a period of 12 weeks (three months). Different skin parameters i.e., skin irritancy, melasma, and sebum contents were measured on both sides of face at baseline and after two weeks interval, using photometric device Mexameter and Sebumeter in a draught free room with modulated conditions of temperature (22-25°C) and humidity (55-60%). It was evident from the results that no primary skin irritancy was observed with patch test. Besides, statistical interpretation indicates that treatment with formulation is superior to placebo because it significantly (p ≤ 0.05) reduced the skin irritancy, melasma and sebum secretions throughout the study and reaching maximum -20.76 ± 0.89, -54.2 ± 0.37 and -40.71 ± 0.75%, respectively, at the end of study period. Antioxidant activity of extract was 92% compared to standard antioxidant. Conclusively, active cream loaded with fruit extract was well tolerated by all the volunteers and suitable to treat contact dermatitis, greasy skin, acne and seborrheic dermatitis and augmenting beauty and attraction by depigmentation of human skin. So, in the future, there is need to clinically evaluate these formulations in patients with compromised skin functions i.e., contact dermatitis, melasma, and acne vulgaris in order to explore the actual potential of this fruit.

  1. Profile of irritant patch testing with detergents: sodium lauryl sulfate, sodium laureth sulfate and alkyl polyglucoside.

    PubMed

    Löffler, H; Happle, R

    2003-01-01

    The cutaneous reaction to detergents follows distinct kinetic rules: the duration of application and the irritant concentration are of major importance. The aim of this study was to evaluate the differences in kinetics of skin reaction between the standard irritant sodium lauryl sulfate (SLS), and 2 modern detergents: sodium laureth sulfate (SLES) and alkyl polyglucoside (APG). We performed patch testing with SLS and SLES (or APG) at different concentrations (0.125, 0.25, 0.5, 1.0 and 2.0%) and with different exposure times (6, 12 and 24 h). Evaluation was conducted by measurement of transepidermal water loss (TEWL) and laser Doppler flowmetry (LD) 24 h, 7 and 10 days after patch removal. We found a pronounced reaction to SLS, and a far milder one to SLES. Even at the highest concentration the skin reaction to APG was hard to detect. During the regeneration period (day 3-10) SLS showed even at day 10 an increased TEWL at all concentrations tested. The irritation due to SLES was convincingly detectable only up to day 7, whereas the APG-tested skin areas showed no significant reaction even at day 3. These results demonstrate the improvement in reduction of skin irritation achieved by development of novel detergents.

  2. Evaluation of modifications of the traditional patch test in assessing the chemical irritation potential of feminine hygiene products.

    PubMed

    Farage, Miranda A; Meyer, Sandy; Walter, Dave

    2004-05-01

    The first main objective of the work presented in this paper was to investigate ways of optimizing the current arm patch test protocol by (1) increasing the sensitivity of the test in order to evaluate more effectively the products that are inherently non-irritating, and/or (2) reducing the costs of these types of studies by shortening the protocol. The second main objective was to use the results of these studies and the results of the parallel studies conducted using the behind-the-knee method to better understand the contribution of mechanical irritation to the skin effects produced by these types of products. In addition, we were interested in continuing the evaluation of sensory effects and their relationship to objective measures of irritation. Test materials were prepared from three, currently marketed feminine protection pads. Wet and dry samples were applied to the upper arm using the standard 24-h patch test. Applications were repeated daily for 4 consecutive days. The test sites were scored for irritation prior to the first patch application, and 30-60 min after removal of each patch. Some test sites were treated by tape stripping the skin prior to the initial patch application. In addition, in one experiment, panelists were asked to keep a daily diary describing any sensory skin effects they noticed at each test site. All protocol variations ([intact skin/dry samples], [compromised skin/dry samples], [intact skin/wet samples], and [compromised skin/wet samples]) gave similar results for the products tested. When compared to the behind-the-knee test method, the standard upper arm patch test gave consistently lower levels of irritation when the test sites were scored shortly after patch removal, even though the sample application was longer (24 vs. 6 h) in the standard patch test. The higher level of irritation in the behind-the-knee method was likely due to mechanical irritation. The sensory skin effects did not appear to be related to a particular test

  3. Irritant and sensitizing potential of eight surfactants commonly used in skin cleansers: an evaluation of 105 patients.

    PubMed

    Corazza, Monica; Lauriola, Maria Michela; Bianchi, Anna; Zappaterra, Mario; Virgili, Annarosa

    2010-01-01

    Irritation from surfactants contained in detergents is a frequent adverse reaction to cosmetics. Sensitization to surfactants is also possible. In the literature, comparative studies about irritant and sensitizing potential of different surfactants are heterogeneous and inconclusive about the best molecules to use. We compared the irritant and sensitizing potential of some surfactants that are usual components in marketed synthetic detergents (syndets) to obtain practical information regarding commonly used detergents. We patch-tested eight surfactants of the different types (anionic, cationic, amphoteric, and non-ionic) in 105 patients. Assessment of allergic reactions of tested surfactants was carried out in accordance with the recommendations of the International Contact Dermatitis Research Group; assessment of irritant power followed the amended Draize classification. None of the eight surfactants in our series gave positive allergic reactions. Only cocamidopropyl betaine from the Italian standard (Società Italiana di Dermatologia Allergologica, Professionale e Ambientale [SIDAPA]) series gave five positive reactions among 105 patients. None of the eight studied surfactants induced skin irritation. The most tolerated are two new mild anionics (sodium cocoyl glutamate and sodium lauroyl oat amino acids) and an amphoteric agent (disodium cocoamphodiacetate). From this study, we deduce that cosmetic companies' efforts to search for and market new products with very mild surfactants have been generally successful.

  4. Hydrophilic Dogwood Extracts as Materials for Reducing the Skin Irritation Potential of Body Wash Cosmetics.

    PubMed

    Nizioł-Łukaszewska, Zofia; Osika, Paweł; Wasilewski, Tomasz; Bujak, Tomasz

    2017-02-19

    A significant problem related to the use of surfactants in body wash cosmetics is their propensity to trigger skin irritations. Only scarce literature exists on the effect of plant extracts on the skin irritation potential. The present study is an attempt to determine the effect of hydrophilic dogwood extracts on the irritant potential of body wash gels. Extractants used in the study were water and mixtures of water with glycerine, water with trimethylglycine (betaine), and water with plant-derived glycol (propanediol). The basic biochemical properties, i.e., the ability to neutralize free radicals, and the content of polyphenols, anthocyanins and flavonoids, were determined. An attempt was undertaken to analyze the impact of the extract added to natural body wash gel formulations on product properties. The skin irritation potential was assessed by determining the zein number and the increase in the pH level of the bovine serum albumin (BSA) solution. The viscosity and foaming ability of the resulting products were evaluated. The studies revealed that an addition of dogwood extract contributes to an improvement in the properties of body wash gels and significantly increases the safety of product use through reducing the skin irritation effect.

  5. Allergy Skin Tests

    MedlinePlus

    ... allergic rhinitis) Allergic asthma Dermatitis (eczema) Food allergies Penicillin allergy Bee venom allergy Latex allergy Skin tests ... check for an allergy to insect venom or penicillin. Patch test Patch testing is generally done to ...

  6. 16 CFR 1500.42 - Test for eye irritants.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., including testing that does not require animals, are presented in the CPSC's animal testing policy set forth... conducted, a sequential testing strategy is recommended to reduce the number of test animals. Additionally... eye irritation. Both eyes of each animal in the test group shall be examined before testing, and only...

  7. 16 CFR § 1500.42 - Test for eye irritants.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... before testing, and only those animals without eye defects or irritation shall be used. The animal is... substances, including testing that does not require animals, are presented in the CPSC's animal testing... conducted, a sequential testing strategy is recommended to reduce the number of test animals. Additionally...

  8. Correlation between pH and irritant effect of cleansers marketed for dry skin.

    PubMed

    Baranda, Lourdes; González-Amaro, Roberto; Torres-Alvarez, Bertha; Alvarez, Carmen; Ramírez, Victoria

    2002-08-01

    Although it is important that dermatologists and the general population know the irritation potential of products marketed for dry skin used for body cleansing, this information is not usually available. To assess the irritative effect of different soaps and liquid cleansers recommended for sensitive skin. To study the correlation of the irritation effect of each substance with its pH and with the presence or absence of syndet in the product. Seventeen products marketed for dry skin and 12 common soaps used by the general population were studied. Fresh soap emulsions (8%) were applied to the volar side of the right forearm of 30 individuals with sensitive skin for 5 consecutive days using aluminum chambers. The appearance of irritation (erythema, scaling and fissures) was recorded, scored, and expressed in an Irritation index (IrIn). The pH of each solution was measured. Products with a low IrIn were White Dove (Dove, Lever Pond's, Toronto, Ontario, Canada), Dove Baby, Cetaphil (bar) (Cetaphil, Gulderma Lab., Forth Worth, TX, USA), Dove liquid cleanser for hands, Dove pink, and Aderma (Adenma, Pierre Fabre, Dermo-Cosmetique, Boulagne, France). Most corresponded to syndet products. Among the most used brand-name soap, Camay Classic (Camay, Procter & Gamble de Mexico, México, U.F.) had the lowest IrIn. Dove Baby was the only product with a neutral pH. A significant correlation between pH and the IrIn of cleansers was found (P < 0.006). Most products recommended for sensitive skin have a considerable irritation effect, which is related to the pH of the product. Better regulation of advertisement specifications including the pH level and type of cleanser contained is necessary for the majority of soaps and cleansers.

  9. In vitro assessment of eye irritancy using the Reconstructed Human Corneal Epithelial SkinEthic HCE model: application to 435 substances from consumer products industry.

    PubMed

    Cotovio, José; Grandidier, Marie-Hélène; Lelièvre, Damien; Bremond, Christelle; Amsellem, Carolle; Maloug, Saber; Ovigne, Jean-Marc; Loisel-Joubert, Sophie; Lee, Aline Van Der; Minondo, Anne-Marie; Capallere, Christophe; Bertino, Béatrice; Alépée, Nathalie; Tinois-Tessonneaud, Estelle; de Fraissinette, Anne De Brugerolle; Meunier, Jean-Roch; Leclaire, Jacques

    2010-03-01

    The 7th amendment of the EU Cosmetics Directive led to the ban of eye irritation testing for cosmetic ingredients in animals, effective from March 11th 2009. Over the last 20years, many efforts have been made to find reliable and relevant alternative methods. The SkinEthic HCE model was used to evaluate the in vitro eye irritancy potential of substances from a cosmetic industry portfolio. An optimized protocol based on a specific 1-h treatment and a 16-h post-treatment incubation period was first assessed on a set of 102 substances. The prediction model (PM) based on a 50% viability cut-off, allowed to draw up two classes (Irritants and Non-Irritants), with good associated sensitivity (86.2%) and specificity (83.5%). To check the robustness of the method, the evaluated set was expanded up to 435 substances. Final performances maintained a high level and were characterized by an overall accuracy value > 82% when using EU or GHS classification rules. Results showed that the SkinEthic HCE test method is a promising in vitro tool for the prediction of eye irritancy. Optimization datasets were shared with the COLIPA Eye Irritation Project Team and ECVAM experts, and reviewed as part of an ongoing progression to enter an ECVAM prospective validation study for eye irritation. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

  10. High molecular compounds (polysaccharides and proanthocyanidins) from Hamamelis virginiana bark: influence on human skin keratinocyte proliferation and differentiation and influence on irritated skin.

    PubMed

    Deters, A; Dauer, A; Schnetz, E; Fartasch, M; Hensel, A

    2001-11-01

    Although extracts from Hamamelis bark have long been used in therapy of skin diseases and in cosmetic formulas there are only few pharmacological investigations verifying the activity of distinct Hamamelis bark constituents. Therefore two major classes of constituents, namely polymeric proanthocyanidins and polysaccharides were isolated from Hamamelis bark and tested concerning their influence on proliferation and differentiation of cultured human keratinocytes. While the polysaccharide fraction, consisting mainly of arabans and arabinogalactans, did not effect human keratinozytes, the proanthocyanidins strongly increased the proliferation of the cells, while the differentiation was not influenced significantly. Within a preliminary cumulative in vivo study on SLS-irritated skin, proanthocyanidins (ProcyanoPlus) were proven to reduce transepidermal water loss and erythema formation. Furthermore, a clinical scoring indicated that procyanidins can influence irritative processes significantly.

  11. 16 CFR 1500.42 - Test for eye irritants.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... before testing, and only those animals without eye defects or irritation shall be used. The animal is held firmly but gently until quiet. The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The...

  12. Proposal of limit concentrations for skin irritation within the context of a new EEC directive on the classification and labeling of preparations

    SciTech Connect

    Jacobs, G.; Martens, M.; Mosselmans, G.

    1987-12-01

    In this study, solvents belonging to different chemical families were tested for their irritating properties to the skin. The irritating potential of a chemical is expressed as its concentration in a nonirritant diluent beyond which irritation of the skin may be expected in the sense of EEC Directive 79/831/EEC. The substances were applied onto the shaved skin of rabbits by means of a modified Finn chamber for 4 hr. Afterward the exposure chamber was removed and the skin cleaned. Reading of erythema and edema was performed according to the scale of Draize at 1, 24, 48, and 72 hr aftermore » the removal of the patch. On the basis of the readings obtained the different dilutions of the organic solvents tested were classified as irritant or not according to the interpretation rules laid down in EEC Directive 83/467/EEC. On the basis of the structure-activity relationships found within each chemical family the irritation potential of the other members of the family could be derived via interpolation.« less

  13. Efficacy of dexpanthenol in skin protection against irritation: a double-blind, placebo-controlled study.

    PubMed

    Biro, Kathrin; Thaçi, Diamant; Ochsendorf, Falk R; Kaufmann, Roland; Boehncke, Wolf-Henning

    2003-08-01

    Dexpanthenol is popular in treating various dermatoses and in skin care, but few controlled clinical trials have been performed. We investigated the efficacy of dexpanthenol in skin protection against irritation in a randomized, prospective, double-blind, placebo-controlled study. 25 healthy volunteers (age 18-45 years) were treated for the inner aspect of both forearms with either Bepanthol Handbalsam containing 5% dexpanthenol or placebo x2 daily for 26 days. From day 15-22, sodium lauryl sulfate (SLS) 2% was applied to these areas x2 daily. Documentation comprised sebumetry, corneometry, pH value and clinical appearance (photographs). 21 volunteers completed the study, 3 were excluded because of non-compliance and 1 experienced a non-study-related, severe, adverse event. Only corneometry yielded a statistically significant difference, with decreased values following SLS challenge at the placebo sites (P < 0.05). Intraindividual comparisons showed superior results at the dexpanthenol-treated sites in 11 cases and in only 1 case at the placebo site. 6 volunteers experienced an irritant contact dermatitis, with more severe symptoms at the placebo site in 5 cases. In conclusion, dexpanthenol exhibits protective effects against skin irritation. The initiation of a study to evaluate the efficacy of dexpanthenol in preventing irritant occupational contact dermatitis under real workplace conditions is validated.

  14. [Cytotoxicity of chemicals used in household products: estimation of eye irritating potency of 25 chemicals tested during 1991-1996].

    PubMed

    Ikarashi, Y; Tsuchiya, T; Nakamura, A

    1997-01-01

    Cytotoxicity potential of chemicals was evaluated by determining the concentrations inducing 50% reduction of neutral red (NR) uptake into Chinese hamster fibroblast V79 cells compared with control culture (IC50). The results of cytotoxicity test for surfactants with the data produced by the in vivo Draize eye and skin irritation test were compared. There was a good correlation between cytotoxicity and eye irritation score obtained from the Draize test. In contrast, no correlation was observed between Draize skin irritation score and cytotoxic potential of chemicals. Therefore, the NR cytotoxicity test was regarded as a possible in vitro model for predicting eye irritation. Based on the IC50 values in the NR cytotoxicity test, the eye irritation classification (weak, moderate and strong) for each chemical used in household products has been established. We evaluated the cytotoxicity of 25 chemicals used for antimicrobial, rubber accelerator, rubber antioxidant, ultraviolet absorber etc. in household products, and estimated the eye irritating potency of these test chemicals according to the criterion.

  15. Changes in hydration of the stratum corneum are the most suitable indicator to evaluate the irritation of surfactants on the skin.

    PubMed

    Fujimura, T; Shimotoyodome, Y; Nishijima, T; Sugata, K; Taguchi, H; Moriwaki, S

    2017-02-01

    Irritancy levels of surfactants on human skin have not been clarified completely. The relationships between skin damage and changes of skin properties caused by various surfactants were investigated using non-invasive measurements. Aqueous solutions of seven kinds of anionic, non-ionic, and amphoteric surfactants were exposed to the inside of forearm skin of 20 human subjects in two separate studies using the cup method. Hydration of the stratum corneum (SC), transepidermal water loss (TEWL), pH, skin surface roughness, and contents of the SC were measured before and after one exposure and after five and nine consecutive exposures to various surfactants. The discontinuation ratio of subjects for testing in each surfactant was determined by skin irritation symptoms and was defined as the degree of skin damage. Significant changes were observed only in hydration, TEWL, and natural moisturizing factors (NMF) content in the SC following surfactant exposure. A significant correlation was observed between the discontinuation ratio of each surfactant and the changes of hydration, TEWL, and NMF. Especially, the change of SC hydration showed an excellent correlation with the discontinuation ratio both for single (r = 0.942, P < 0.001) and for chronic exposures (r = 0.934, P < 0.001). Our results indicate that the change of hydration of the SC is equivalent to the skin damage caused by surfactants, and therefore is the most suitable indicator to evaluate the irritation of surfactants on the skin. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  16. Ceramide 1 and ceramide 3 act synergistically on skin hydration and the transepidermal water loss of sodium lauryl sulfate-irritated skin.

    PubMed

    Huang, Huey-Chun; Chang, Tsong-Min

    2008-08-01

    Stratum corneum intercellular lipids, such as ceramides, play an important role in the regulation of skin water barrier homeostasis and water-holding capacity. Aim To evaluate the potential water retention capacity of control emulsion and three oil-in-water (o/w) emulsions containing ceramide 1, ceramide 3, or both. Fifteen healthy Asian women (age, 20-30 years) with healthy skin, pretreated with sodium lauryl sulfate (SLS), applied the tested emulsions twice daily over a period of 28 days. Skin hydration and transepidermal water loss (TEWL) values were measured on the indicated days with a Corneometer(R)825 and a TEWAMETER TM210, respectively. The maximum increase in skin humidity was reached after 4 weeks, with values of 21.9 +/- 1.8% and 8.9 +/- 0.9% for emulsion C and control emulsion, respectively. The maximum decrease in TEWL was also reached after 4 weeks, with values of 36.7 +/- 4.7% and 5.1 +/- 0.8% for the same emulsions. It can be concluded that all the tested ceramide-containing emulsions improved skin barrier function when compared with untreated skin. There was some indication that ceramides 1 and 3 contained in emulsion C might exert a beneficial synergistic effect on skin biochemical properties, such as skin hydration and TEWL, and play a key role in the protection mechanism against SLS irritation.

  17. Alp Rose stem cells, olive oil squalene and a natural alkyl polyglucoside emulsifier: Are they appropriate ingredients of skin moisturizers - in vivo efficacy on normal and sodium lauryl sulfate - irritated skin?.

    PubMed

    Filipović, Mila; Gledović, Ana; Lukić, Milica; Tasić-Kostov, Marija; Isailović, Tanja; Pantelić, Ivana; Vuleta, Gordana; Savić, Snežana

    2016-11-01

    Since skin moisturization may be achieved by both actives and chosen carrier, plant stem cells, squalene and natural alkyl polyglucoside emulsifier may be potential components of contemporary cosmetic products. The aim of the study was in vivo evaluation of the skin irritation potential and the efficacy of Alpine Rose stem cells incorporated into li-posomes and olive oil squalene as ingredients of moisturizing creams, with respect to the novel emulsifier used for creams’ stabilization. With the employment of noninvasive skin biophysical measurements, skin hydration (EC), transepi-dermal water loss (TEWL), erythema index (EI) and viscoelas-ticity were measured on 76 healthy volunteers. In the first phase, skin irritation after a 24-hour occlusion and the long-term efficacy of creams (a 21-day study) on healthy skin were evaluated. Phase II of the study focused on the cream efficacy assessment after a 6-day treatment of sodium lauryl sulfate-irritated skin. After a 24-hour occlusion, there were no significant changes in the EI for any tested sample. In the second phase of the study, the EI was not significantly altered for the cream containing squalene, while the application of all active samples resulted in a significant reduction of TEWL. In both phases of the study an EC increase was recorded, espe-cially for the squalene-containing cream. Due to the lack of skin irritation and skin barrier impairment along with the marked hydration effect, it could be said that the in-vestigated actives incorporated into alkyl polyglucoside emulsi-fier-stabilized creams may be safely applied as ingredients for "tailor-made" cosmetic moisturizers intended for normal and dry skin care, whereas olive oil squalene could be used for the treatment of irritated or sensitive skin as well. [Projekat Ministarstva nauke Republike Srbije, br. TR34031

  18. Assessment of the in vitro dermal irritation potential of cerium, silver, and titanium nanoparticles in a human skin equivalent model

    EPA Science Inventory

    AbstractDermal exposure to metals may res·ult in irritant contact dermatitis. This study examined the potential of metal nanoparticles to elicit irritant contact dermatitis in a human skin equivalent model (HSEM) derived from epidermal keratinocytes. These cultured cells form a m...

  19. The Ex Vivo Eye Irritation Test as an alternative test method for serious eye damage/eye irritation.

    PubMed

    Spöler, Felix; Kray, Oya; Kray, Stefan; Panfil, Claudia; Schrage, Norbert F

    2015-07-01

    Ocular irritation testing is a common requirement for the classification, labelling and packaging of chemicals (substances and mixtures). The in vivo Draize rabbit eye test (OECD Test Guideline 405) is considered to be the regulatory reference method for the classification of chemicals according to their potential to induce eye injury. In the Draize test, chemicals are applied to rabbit eyes in vivo, and changes are monitored over time. If no damage is observed, the chemical is not categorised. Otherwise, the classification depends on the severity and reversibility of the damage. Alternative test methods have to be designed to match the classifications from the in vivo reference method. However, observation of damage reversibility is usually not possible in vitro. Within the present study, a new organotypic method based on rabbit corneas obtained from food production is demonstrated to close this gap. The Ex Vivo Eye Irritation Test (EVEIT) retains the full biochemical activity of the corneal epithelium, epithelial stem cells and endothelium. This permits the in-depth analysis of ocular chemical trauma beyond that achievable by using established in vitro methods. In particular, the EVEIT is the first test to permit the direct monitoring of recovery of all corneal layers after damage. To develop a prediction model for the EVEIT that is comparable to the GHS system, 37 reference chemicals were analysed. The experimental data were used to derive a three-level potency ranking of eye irritation and corrosion that best fits the GHS categorisation. In vivo data available in the literature were used for comparison. When compared with GHS classification predictions, the overall accuracy of the three-level potency ranking was 78%. The classification of chemicals as irritating versus non-irritating resulted in 96% sensitivity, 91% specificity and 95% accuracy. 2015 FRAME.

  20. Efficacy of a Hand Regimen in Skin Barrier Protection in Individuals With Occupational Irritant Contact Dermatitis.

    PubMed

    Jordan, Laura

    2016-11-01

    Occupational irritant contact dermatitis (OICD) is a dif cult and hard to manage condition. It occurs more frequently in certain occupations where contact with harsh chemicals, use of alcohol-based disinfectants, and frequent hand washing heightens the risk. Treatment for OICD includes patient education in addition to physical, topical, and systemic therapies. To review the pathogenesis and treatment options for OICD and evaluate the ef cacy of a selective skin-care regimen involv- ing a hand protectant cream alone as well as combined with a repair cream and speci c cleanser. A single-center open study was performed comprising 42 healthy male and female adult volunteers prone to occupational irritant contact dermatitis due to frequent wet work or contact with detergents. Between day 0 and day 7, subjects applied a hand protectant cream as needed on both hands (at least twice daily). On days 7 to 14, subjects applied a hand protectant cream and cleanser as needed on both hands (at least twice daily) as well as a repair cream each evening. A diary log was given to each volunteer for application control and for a subjective evaluation of daily tolerability. In these subjects prone to occupational irritant contact dermatitis, the hand protectant cream applied during the initial 7-day period was effective in restoring the damaged skin barrier and improving the stratum corneum hydration. A regimen that combined the hand protectant and repair creams with a speci c cleanser during a further 7-day period allowed contin- ued improvement of skin hydration and additional clinical bene ts while respecting the skin barrier function. The results of this study support the use of a 3-step approach for patients who are at risk of repeated exposure to external irritants. J Drugs Dermatol. 2016;15(suppl 11):s81-85..

  1. Testing ocular irritancy in vitro with the silicon microphysiometer.

    PubMed

    Bruner, L H; Miller, K R; Owicki, J C; Parce, J W; Muir, V C

    1991-01-01

    The silicon microphysiometer, an instrument based on the light-addressable potentiometric sensor, was evaluated as an in vitro alternative for assessing ocular irritancy potential. It indirectly and non-invasively measures cell metabolism by determining the rate of acid metabolite production from cells, in this case human epidermal keratinocytes, placed inside the microphysiometer chamber. The 17 materials used for the evaluation included bar soaps, a liquid hand soap, shampoos, dishwashing liquids, laundry detergents, a fabric softener and several single chemicals. All materials tested were in liquid form. The in vivo irritancy potential of the materials was obtained from historical data using the rabbit low-volume eye test. There was a positive correlation between the in vivo irritancy potential of the test materials and the concentration of test material that decreased the acidification rate of cells by 50% (MRD(50); r = 0.86, P < 0.0001). Preliminary studies suggest other endpoints obtainable from the system may also provide useful information for making ocular safety assessments. Because the method is non-invasive, it is possible to determine whether cells recover from a treatment with the test material. The metabolic rate of the cells also increases at sub-inhibitory concentrations of some of the test materials. Because of the good correlation between the in vivo and in vitro data, the ease with which test materials can be applied to the system, and the multiple endpoints available from the system, it holds great potential as a useful in vitro alternative for ocular safety testing.

  2. Echo: skin stress test

    NASA Image and Video Library

    1960-05-14

    Photographed in 1960. -- Skin Stress Test of the 12-foot satellite built as a prototype of the full-scale Echo satellite. The 12-foot diameter of the sphere was chosen because that was the ceiling height in the Langley model shop. The proposal to build the 12-foot satellite was made in November 1957. -- Published in James R. Hansen, Spaceflight Revolution: NASA Langley Research Center From Sputnik to Apollo, NASA SP-4308, pp. 170-171.

  3. The evaluation of the local tolerance of vaginal formulations containing dapivirine using the Slug Mucosal Irritation test and the rabbit vaginal irritation test.

    PubMed

    Dhondt, Marijke M M; Adriaens, Els; Roey, Jens Van; Remon, Jean Paul

    2005-08-01

    The purpose of this study was to evaluate the local tolerance of vaginal gels (three gels containing dapivirine, the placebo gel, and Conceptrol) with the Slug Mucosal Irritation test and to compare the results with those of the rabbit vaginal irritation test. The irritation potential on the slug mucosa was assessed by the mucus production caused by a repeated treatment for 5 successive days. Additionally, membrane damage was estimated by the protein and enzyme release. By means of a classification prediction model the formulations were classified into four irritation classes. The effect of a 10-day intravaginal application of the gels on the rabbit vaginal and cervical mucosa was evaluated by means of macroscopic and microscopic examination. The placebo and dapivirine gels induced no irritation of the slug mucosa (low mucus production and protein release, no enzyme release) and no vaginal or cervical irritation in rabbits. Conceptrol caused severe irritation of the slug mucosa (increased mucus production, protein release, and enzyme release) and irritation of the rabbit vagina and cervix. The results obtained with the Slug Mucosal Irritation test were comparable to those of the rabbit vaginal irritation test.

  4. The skin prick test.

    PubMed

    Frati, F; Incorvaia, C; Cavaliere, C; Di Cara, G; Marcucci, F; Esposito, S; Masieri, S

    2018-01-01

    The skin prick test (SPT) is the most common test for the diagnosis of allergy. SPT is performed by pricking the skin, usually in the volar surface of the forearm, with a lancet through a drop of an allergen extract and is usually the first choice test in the diagnostic workup for allergic diseases because of its reliability, safety, convenience and low cost. SPT is minimally invasive and has the advantage of testing multiple allergens in 15 to 20 min. In children, SPT is far less disturbing than venipuncture and is used to obtain a sample of serum to measure specific IgE through in vitro tests. There is a good correlation (about 85-95%) between SPT and in vitro tests. Globally, SPT is an excellent diagnostic tool, with a positive predictive value ranging from 95-100%. SPTs can identify sensitivity to inhalants, foods, some drugs, occupational allergens, hymenoptera venom and latex. However, the relevance of such sensitivity to allergens should always be carefully interpreted in the light of the clinical history, because sensitization and clinical allergy may not coincide. In regards to safety, though the reports of systemic reactions, and particularly anaphylaxis, are very rare, in vitro IgE tests should be preferred if previous severe reactions emerge from the patient’s clinical history.

  5. Irritancy ranking of 31 cleansers in the Indian market in a 24-h patch test.

    PubMed

    Lakshmi, C; Srinivas, C R; Anand, C V; Mathew, A C

    2008-08-01

    Cleansing trends promise freshness, sensory and health benefits but may also be accompanied by an increase in soap-induced skin irritation. The aim of this study was to evaluate the irritant effect of 31 cleansers (28 bar soaps and 3 liquid cleansers) available in the Indian market. Eight percent w/v solutions of the soaps/cleansers were made and 30 microL of each of the solutions were applied to Finn chambers and occluded for 24 h along with distilled water (negative control) and 20% sodium dodecyl sulphate (SDS) as positive control. The sites were graded for erythema and scaling 30 min after removing the patches. The pH of each of the soap solutions was determined. Mean with SD and ANOVA (F-value) was computed separately for each soap/cleanser with respect to the two parameters, erythema and scaling. The total of the means for both the parameters, erythema and scaling was also computed. The cleansers were listed based on this total from the least irritant to the most irritant. The differences between soaps (F-value) was significant for erythema and scaling [erythema = 4.106 (P = 0.000); scaling = 6.006 (P = 0.000)]. Cetaphil cleansing lotion had the lowest erythema score of 0.25. Lowest scaling score of zero was recorded for Cetaphil cleansing lotion and Elovera moisturizing body wash. Aquasoft and Lifebuoy soaps had the highest erythema score of 2.13. Acnex had the highest scaling score of 1.75; Aquasoft, Hamam scrub bath soap and Naturepower sandal soaps were the next with a scaling score of 1.63. Cetaphil cleansing lotion, Aquaderm liquid soap, Dove bar soap and Elovera moisturizing body wash proved to be the least irritant cleansers with a total score of less than 1. The four most irritant soaps/cleansers had an average score of 3.65. The irritant potential of the majority of the cleansers fell between these extremes. The pH of all the soap/cleanser solutions was neutral to alkaline (pH 7-9) except that of Dove bar, Cetaphil cleansing lotion, Aquaderm liquid

  6. Effects of topical corticosteroid and tacrolimus on ceramides and irritancy to sodium lauryl sulphate in healthy skin.

    PubMed

    Jungersted, Jakob Mutanu; Høgh, Julie K; Hellegren, Lars I; Jemec, Gregor B E; Agner, Tove

    2011-05-01

    The skin barrier, located in the stratum corneum, is influenced mainly by the lipid and protein composition of this layer. In eczematous diseases impairment of the skin barrier is thought to be of prime importance. Topical anti-inflammatory drugs and emollients are the most widely used eczema treatments. The aim of this study was to examine the effects of topically applied corticosteroid, tacrolimus and emollient on stratum corneum lipids and barrier parameters. Nineteen healthy volunteers participated in the study. Both forearms of the subjects were divided into four areas, which were treated twice daily for one week with betamethasone, tacrolimus, emollient, or left untreated, respectively. After one week each area was challenged with a 24 h sodium lauryl sulphate patch test. The lipids were collected using the cyanoacrylate method and evaluated by high performance thin layer chromatography. For evaluation of the skin barrier, transepidermal water loss, erythema and electrical capacitance were measured. The ceramide/cholesterol ratio was increased in betamethasone- (p = 0.008) and tacrolimus-treated (p = 0.025) skin compared with emollient-treated skin. No differences in ceramide subgroups were found between treatment regimes. Pretreatment with betamethasone (p = 0.01) or with tacrolimus (p = 0.001) causes a decreased inflammatory response to sodium lauryl sulphate compared with emollient. In conclusion, treatment with betamethasone and tacrolimus has a positive effect on the ceramide/cholesterol ratio and susceptibility to irritant reaction compared with an emollient.

  7. Noninvasive measuring methods for the investigation of irritant patch test reactions. A study of patients with hand eczema, atopic dermatitis and controls.

    PubMed

    Agner, T

    1992-01-01

    The aim of the study was to assess the susceptibility of clinically normal skin to a standard irritant trauma under varying physiological and patophysiological conditions. Evaluation of skin responses to patch tests with sodium lauryl sulphate (SLS) was used for assessment of skin susceptibility. The following noninvasive measuring methods were used for evaluation of the skin before and after exposure to irritants: measurement of transepidermal water loss by an evaporimeter, measurement of electrical conductance by a hydrometer, measurement of skin blood flow by laser Doppler flowmetry, measurement of skin colour by a colorimeter and measurement of skin thickness by ultrasound A-scan. The studies were carried out on healthy volunteers and patients with eczema. In the first studies the standard irritant patch test for assessment of skin susceptibility was characterized and validated. SLS was chosen among other irritants because of its ability to penetrate and impair the skin barrier. The implications of use of different qualities of SLS was investigated. The applied noninvasive measuring methods were evaluated, and for quantification of SLS-induced skin damage measurement of TEWL was found to be the most sensitive method. Application of the standard test on clinically normal skin under varying physiological and patophysiological conditions lead to the following main results: Seasonal variation in skin susceptibility to SLS was found, with increased susceptibility in winter, when the hydration state of the stratum corneum was also found to be decreased. A variation in skin reactivity to SLS during the menstrual cycle was demonstrated, with an increased skin response at day 1 as compared to days 9-11 in the menstrual cycle. The presence of active eczema distant from the test site increased skin susceptibility to SLS, indicating a generalized hyperreactivity of the skin. Taking these sources of variation into account healthy volunteers and patients with hand eczema and

  8. Dermal toxicity, eye and dermal irritation and skin sensitization evaluation of a new formulation of Bacillus thuringiensis var israelensis SH-14.

    PubMed

    Arteaga, M E; Mancebo, A; Molier, T; Gómez, D; González, C; Bada, A M; González, B; Rojas, N M; Rodríguez, G

    2014-02-01

    Bacillus thuringiensis (Bt) is the best known and most widely used of all pesticidal microbes. The aim of this study was to assess the toxicity of a new formulation of Bacillus thuringiensis var israelensis SH-14 in rats through acute dermal toxicity, dermal and eye irritation experiments. The acute dermal toxicity and dermal and eye irritation studies were performed using rabbits according to the United States Environmental Protection Agency guidelines 885.3100, 870.2500 and 870.2500, respectively. The skin sensitization study was carried out in accordance to the EPA OPPTS 870.2600 using guinea pigs. There was no mortality and no evidence of treatment-related toxicity in acute dermal toxicity test. No dermal responses, including erythema/eschar or edema, were found in rabbits treated with the new formulation of Bti SH-14. Minimum response was observed after eye application of test substance. No skin sensitization reactions were observed after the challenge with the new formulation of Bti SH-14 in the Bti SH-14-treated guinea pigs. In summary, the present study demonstrated that the new formulation of Bti SH-14 is not acutely toxic via dermal route, has low eye irritation and would not cause dermal irritation or hypersensitivity to tested animals. Copyright © 2013 Elsevier Inc. All rights reserved.

  9. In vivo assessment of cytological changes by means of reflectance confocal microscopy - demonstration of the effect of topical vitamin E on skin irritation caused by sodium lauryl sulfate.

    PubMed

    Casari, Alice; Farnetani, Francesca; De Pace, Barbara; Losi, Amanda; Pittet, Jean-Christophe; Pellacani, Giovanni; Longo, Caterina

    2017-03-01

    Irritant contact dermatitis is caused by skin barrier damage. Vitamin E is an antioxidant that is commonly used in cosmetics to prevent photo-damage. To show the usefulness of reflectance confocal microscopy in the assessment of irritant skin damage caused by sodium lauryl sulfate (SLS) and of the protective action of vitamin E applied prior to skin irritation. Ten healthy volunteers were enrolled. Irritation was induced by the application of a patch test containing SLS 5% aq. for 24 h. Three sites were compared: one site on which a product with vitamin E was applied before SLS treatment, one site on which the same product was applied after SLS treatment, and one control site (SLS only). Each site was evaluated with reflectance confocal microscopy, providing in vivo tissue images at nearly histological resolution. We also performed a computerized analysis of the VivaStack® images. Reflectance confocal microscopy is able to identify signs of skin irritation and the preventive effect of vitamin E application. Reflectance confocal microscopy is useful in the objective assessment of irritative skin damage. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  10. Safety Evaluation of Silk Protein Film (A Novel Wound Healing Agent) in Terms of Acute Dermal Toxicity, Acute Dermal Irritation and Skin Sensitization

    PubMed Central

    Padol, Amol R.; Jayakumar, K.; Shridhar, N. B.; Narayana Swamy, H. D.; Narayana Swamy, M.; Mohan, K.

    2011-01-01

    Acute dermal toxicity study was conducted in rats. The parameters studied were body weight, serum biochemistry and gross pathology. The animals were also observed for clinical signs and mortality after the application of test film. The dermal irritation potential of silk protein film was examined using Draize test. In the initial test, three test patches were applied sequentially for 3 min, 1 and 4 hours, respectively, and skin reaction was graded. The irritant or negative response was confirmed using two additional animals, each with one patch, for an exposure period of 4 hours. The responses were scored at 1, 24, 48 and 72 hours after the patch removal. Skin sensitization study was conducted according to Buehler test in guinea pigs, in which on day 0, 7 and 14, the animals were exposed to test material for 6 hours (Induction phase) and on day 28, the animals were exposed for a period of 24 hours (Challenge phase). The skin was observed and recorded at 24 and 48 hours after the patch removal. In acute dermal toxicity study, the rats dermally treated with silk film did not show any abnormal clinical signs and the body weight, biochemical parameters and gross pathological observations were not significantly different from the control group. In acute dermal irritation study, the treated rabbits showed no signs of erythema, edema and eschar, and the scoring was given as “0” for all time points of observations according to Draize scoring system. In skin sensitization study, there were no skin reactions 24 and 48 hours after the removal of challenge patch, which was scored “0” based on Magnusson/Kligman grading scale. PMID:21430915

  11. Allergy testing - skin

    MedlinePlus

    ... if you're allergic to bee venom or penicillin. Or it may be used if the skin ... sore, or swollen after contact with the substance Penicillin allergy Venom allergy Allergies to penicillin and related ...

  12. Cumulative irritation potential of metronidazole gel compared to azelaic acid gel after repeated applications to healthy skin.

    PubMed

    Ziel, Kristin; Yelverton, Christopher B; Balkrishnan, Rajesh; Feldman, Steven R

    2005-01-01

    Metronidazole 0.75% gel and azelaic acid 15% gel are commonly used to treat rosacea. Irritation is a common side effect. To assess the cumulative irritation potential of metronidazole 0.75% gel and azelaic acid 15% gel. Metronidazole 0.75% gel, azelaic acid 15% gel, and a white petrolatum negative control were applied under occlusive conditions to the upper back of a total of 33 healthy subjects. There were twelve 24-hour applications (4 times a week) and three 72-hour applications on weekends during a 3-week period. Skin reactions (erythema score +/- other local reaction) were assessed within 15 to 30 minutes of removal of the products. The mean cumulative irritancy index of metronidazole 0.75% gel was significantly lower than that of azelaic acid 15% gel and not significantly higher than the negative control product. There was increasing cumulative irritancy with azelaic acid; no cumulative irritancy was seen for either metronidazole or white petrolatum. Metronidazole 0.75% gel is less irritating in sustained use than azelaic acid 15% gel.

  13. Evaluation of ocular irritancy of coal-tar dyes used in cosmetics employing reconstructed human cornea-like epithelium and short time exposure tests.

    PubMed

    Lee, Miri; Nam, Ki Taek; Kim, Jungah; Lim, Song E; Yeon, Sang Hyeon; Lee, Buhyun; Lee, Joo Young; Lim, Kyung-Min

    2017-10-01

    Coal-tar dyes in cosmetics may elicit adverse effects in the skin and eyes. Countries, like the US, have banned the use of coal-tar dyes in cosmetics for the eye area due to the potential for ocular irritation. We evaluated the eye irritation potential of 15 coal-tar dyes permitted as cosmetic ingredients in reconstructed human cornea-like epithelium (RhCEs [EpiOcular™ and MCTT HCE™]) tests and the short time exposure (STE) test. Eosin YS, phloxine B, tetrachlorotetrabromofluorescein, and tetrabromofluorescein were identified as irritants in RhCEs; dibromofluorescein and uranine yielded discrepant results. STE enabled further classification in accordance with the UN Globally Harmonized System of Classification and Labelling of Chemicals, as follows: eosin YS as Cat 2; phloxine B, Cat 1; and tetrachlorotetrabromofluorescein and tetrabromofluorescein, Cat 1/2. STE indicated dibromofluorescein (irritant in EpiOcular™) and uranine (irritant in MCTT HCE™) as No Cat, resulting in the classification of "No prediction can be made." based on bottom-up approach with each model. These results demonstrated that in vitro eye irritation tests can be utilized to evaluate the potential ocular irritancy of cosmetic ingredients and provide significant evidence with which to determine whether precautions should be given for the use of coal-tar dyes in cosmetics or other substances applied to the eye area. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. CON4EI: Development of serious eye damage and eye irritation testing strategies with respect to the requirements of the UN GHS/EU CLP hazard categories.

    PubMed

    Verstraelen, Sandra; Van Rompay, An R

    2018-06-01

    The main objective of the CON4EI (CONsortium for in vitro Eye Irritation testing strategy) project (2015-2016) was to develop tiered, non-animal testing strategies for serious eye damage and eye irritation assessment in relation to the most important drivers of classification. The serious eye damage and eye irritation potential of a set of 80 chemicals was identified based on existing in vivo Draize eye test data and testing was conducted using the following eight alternative test methods: BCOP (Bovine Corneal Opacity and Permeability)+histopathology, BCOP-LLBO (BCOP Laser Light-Based Opacitometer), ICE (Isolated Chicken Eye)+histopathology, STE (Short Term Exposure), EpiOcular™ EIT (EpiOcular Eye Irritation Test), EpiOcular™ ET-50 (EpiOcular™ Time-to-toxicity), SkinEthic™ HCE EIT (SkinEthic™ Human Corneal Epithelial Eye Irritation Test), and SMI (Slug Mucosal Irritation). Project management decided to not include the ICE data in this project since the execution showed relevant, and not predictable, deviations from Organisation for Economic Co-operation and Development (OECD) Test Guideline (TG) 438 and Guidance Document 160. At this stage, the outcome of these deviations has not been fully assessed. In addition to these alternative test methods, the computational models Toxtree and Case Ultra were taken into account. This project assessed the relevance of these test methods, their applicability domains and limitations in terms of 'drivers of classification', and their strengths and weaknesses. In this way, methods were identified that fit into a tiered-testing strategy for serious eye damage/eye irritation assessment to distinguish United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS) Category 1 (Cat 1) chemicals from non-Cat 1 chemicals and address the gap namely distinguish between Category 2 (Cat 2) and Cat 1 chemicals. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. Flu Vaccine Skin Patch Tested

    MedlinePlus

    ... Subscribe September 2017 Print this issue Health Capsule Flu Vaccine Skin Patch Tested En español Send us ... Each year, millions of people nationwide catch the flu. The best way to protect yourself is to ...

  16. Exploration and comparison of in vitro eye irritation tests with the ISO standard in vivo rabbit test for the evaluation of the ocular irritancy of contact lenses.

    PubMed

    Yun, Jun-Won; Hailian, Quan; Na, Yirang; Kang, Byeong-Cheol; Yoon, Jung-Hee; Cho, Eun-Young; Lee, Miri; Kim, Da-Eun; Bae, SeungJin; Seok, Seung Hyeok; Lim, Kyung-Min

    2016-12-01

    In an effort to explore the use of alternative methods to animal testing for the evaluation of the ocular irritancy of medical devices, we evaluated representative contact lenses with the bovine corneal opacity and permeability test (BCOP) and an in vitro eye irritation test using the three-dimensionally-reconstructed human corneal epithelium (RhCE) models, EpiOcular™ and MCTT HCE™. In addition, we compared the obtained results with the ISO standard in vivo rabbit eye irritation test (ISO10993-10). Along with the positive controls (benzalkonium chloride, BAK, 0.02, 0.2, and 1%), the extracts of 4 representative contact lenses (soft, disposable, hard, and colored lenses) and 2 reference lenses (dye-eluting and BAK-coated lenses) were tested. All the lenses, except for the BAK-coated lens, were determined non-irritants in all test methods, while the positive controls yielded relevant results. More importantly, BCOP, EpiOcular™, and MCTT HCE™ yielded a consistent decision for all the tested samples, with the exception of 0.2% BAK in BCOP, for which no prediction could be made. Overall, all the in vitro tests correlated well with the in vivo rabbit eye irritation test, and furthermore, the combination of in vitro tests as a tiered testing strategy was able to produce results similar to those seen in vivo. These observations suggest that such methods can be used as alternative assays to replace the conventional in vivo test method in the evaluation of the ocular irritancy of ophthalmic medical devices, although further study is necessary. Copyright © 2016. Published by Elsevier Ltd.

  17. The Behind-the-Knee test: an efficient model for evaluating mechanical and chemical irritation.

    PubMed

    Farage, Miranda A

    2006-05-01

    The 'Behind-the-Knee' method (BTK test), using the popliteal fossa as a test site, evaluates both the inherent chemical irritation, and the potential for mechanical irritation of substrates and products. This approach eliminates some of the difficulties of in-use clinical test systems while still providing reliable results. In this publication, examples of the results of BTK tests on several materials are presented with direct comparisons, where possible, with results of in-use clinical testing conducted on the same materials. In in-use clinical tests, volunteer panelists were provided with catamenial products to use in place of their normal product. In the BTK test, samples were applied daily to the popliteal fossa using an elastic athletic band. In both studies, irritation reactions were scored visually. Levels of irritation in the BTK test are consistently higher than those of standard patch tests, illustrating the contribution of mechanical irritation to the overall irritant potential of materials and products. Repeated tests on identical test materials demonstrated that the BTK test results are reproducible. Side-by-side comparisons of the BTK test and in-use clinical tests demonstrated that the BTK test produces results of similar quality to the in-use clinical. By using several concurrent panels with a common test material, it is possible to compare the irritant properties of several materials at once. We have tested over 25 different materials in over 35 BTK studies. The test method has proven reliable and versatile in testing a wide variety of materials, including menstrual pads, topsheets, interlabial pads, pantiliners, tampons and lotion coatings on products. Unlike in-use clinicals, the BTK test allows the direct comparison of two products at one time on the same individual, and is easily adapted to investigative programs. It is subject to fewer confounding factors, is much easier to implement, has a shorter turnaround time, and is less expensive than

  18. Lepromin skin test

    MedlinePlus

    ... infection if left untreated. It is caused by Mycobacterium leprae bacteria. This test is a research tool that ... Renault CA, Ernst JD. Mycobacterium leprae (leprosy). In: Bennett JE, ... Principles and Practice of Infectious Diseases, Updated ...

  19. Non-Animal Testing Approach to EPA Labeling for Eye Irritation

    EPA Pesticide Factsheets

    This document is an update to EPA’s 2013 published alternative testing approach (using in vitro/ex vivo assays) for determination of eye irritation potential in the pesticide program under EPA's classification and labeling system.

  20. [Efficacy and patient benefit of treatment of irritated skin with ointments containing dexpanthenol: health services research (observational study) on self-medication in a pharmaceutical network].

    PubMed

    Radtke, M A; Lee-Seifert, C; Rustenbach, S J; Schäfer, I; Augustin, M

    2009-05-01

    Products containing dexpanthenol are used to treat irritated and inflamed skin. So far there is a lack of data for the evidence of patient-relevant benefits. Assessment of the patient-relevant benefit of ointments containing dexpanthenol in the self-medicated therapy of irritated skin. Prospective, observational study in a network of 392 pharmacies. Consecutive recruitment of n=1,886 patients with symptoms of irritated skin, including non-inflammatory intervals of atopic eczema, other xerotic skin conditions and impairment of skin barrier. The patient-relevant benefit was ascertained prior to and 7-10 days after treatment through the patient-benefit index (PBI). The PBI showed that 91.5% of the patients experienced a relevant benefit from treatment. 94.7% directly indicated to have had achieved successful therapeutic results. All symptoms of irritated skin (e.g. xerosis, erythema, desquamation) significantly improved (pskin disease. High patient-relevant benefits were observed in the treatment of irritated skin with dexpanthenol ointment.

  1. Leishmania Skin Test

    DTIC Science & Technology

    2010-03-01

    LtSTA. Unlike local AE where the reaction site can be identified with a specific article , it was not possible to identify the article responsible...taken prior to the last centrifugation step to determine yield (cell concentration), bioburden and morphology. The final centrifugation run is...protein and phenol may be made one time with 1X phosphate diluent. Bioburden is tested after any adjustment is made and prior to sterile filtration

  2. Nanostructured lipid carriers-based flurbiprofen gel after topical administration: acute skin irritation, pharmacodynamics, and percutaneous absorption mechanism.

    PubMed

    Song, Aihua; Su, Zhen; Li, Sanming; Han, Fei

    2015-01-01

    In order to assess the preliminary safety and effectiveness of nanostructured lipid carriers-based flurbiprofen gel (FP NLC-gel), the acute irritation test, in vivo pharmacodynamics evaluation and pharmacokinetic study were investigated after topical application. No dropsy and erythema were observed after continuous dosing 7 d of FP NLC-gel on the rabbit skin, and the xylene-induced ear drossy could be inhibited by FP NLC-gel at different dosages. The maximum concentration of FP in rats muscle was 2.03 μg/g and 1.55 μg/g after oral and topical administration, respectively. While the peak concentration in untreated muscle after topical administration was only 0.37 μg/mL. And at any time, following topical administration the mean muscle-plasma concentration ratio Cmuscle/CPlasma was obviously higher than that following oral administration. Results indicated that FP could directly penetrate into the subcutaneous muscle tissue from the administration site. Thus, the developed FP NLC-gel could be a safe and effective vehicle for topical delivery of FP.

  3. An in vitro human skin test for assessing sensitization potential.

    PubMed

    Ahmed, S S; Wang, X N; Fielding, M; Kerry, A; Dickinson, I; Munuswamy, R; Kimber, I; Dickinson, A M

    2016-05-01

    Sensitization to chemicals resulting in an allergy is an important health issue. The current gold-standard method for identification and characterization of skin-sensitizing chemicals was the mouse local lymph node assay (LLNA). However, for a number of reasons there has been an increasing imperative to develop alternative approaches to hazard identification that do not require the use of animals. Here we describe a human in-vitro skin explant test for identification of sensitization hazards and the assessment of relative skin sensitizing potency. This method measures histological damage in human skin as a readout of the immune response induced by the test material. Using this approach we have measured responses to 44 chemicals including skin sensitizers, pre/pro-haptens, respiratory sensitizers, non-sensitizing chemicals (including skin-irritants) and previously misclassified compounds. Based on comparisons with the LLNA, the skin explant test gave 95% specificity, 95% sensitivity, 95% concordance with a correlation coefficient of 0.9. The same specificity and sensitivity were achieved for comparison of results with published human sensitization data with a correlation coefficient of 0.91. The test also successfully identified nickel sulphate as a human skin sensitizer, which was misclassified as negative in the LLNA. In addition, sensitizers and non-sensitizers identified as positive or negative by the skin explant test have induced high/low T cell proliferation and IFNγ production, respectively. Collectively, the data suggests the human in-vitro skin explant test could provide the basis for a novel approach for characterization of the sensitizing activity as a first step in the risk assessment process. Copyright © 2015 John Wiley & Sons, Ltd.

  4. 16 CFR § 1500.41 - Method of testing primary irritant substances.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... testing that does not require animals, are presented in the CPSC's animal testing policy set forth in 16... recommended to reduce the number of test animals. The method of testing the dermal corrosivity and primary... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Method of testing primary irritant...

  5. Survey of ocular irritation predictive capacity using Chorioallantoic Membrane Vascular Assay (CAMVA) and Bovine Corneal Opacity and Permeability (BCOP) test historical data for 319 personal care products over fourteen years.

    PubMed

    Donahue, D A; Kaufman, L E; Avalos, J; Simion, F A; Cerven, D R

    2011-03-01

    The Chorioallantoic Membrane Vascular Assay (CAMVA) and Bovine Corneal Opacity and Permeability (BCOP) test are widely used to predict ocular irritation potential for consumer-use products. These in vitro assays do not require live animals, produce reliable predictive data for defined applicability domains compared to the Draize rabbit eye test, and are rapid and inexpensive. Data from 304 CAMVA and/or BCOP studies (319 formulations) were surveyed to determine the feasibility of predicting ocular irritation potential for various formulations. Hair shampoos, skin cleansers, and ethanol-based hair styling sprays were repeatedly predicted to be ocular irritants (accuracy rate=0.90-1.00), with skin cleanser and hair shampoo irritation largely dependent on surfactant species and concentration. Conversely, skin lotions/moisturizers and hair styling gels/lotions were repeatedly predicted to be non-irritants (accuracy rate=0.92 and 0.82, respectively). For hair shampoos, ethanol-based hair stylers, skin cleansers, and skin lotions/moisturizers, future ocular irritation testing (i.e., CAMVA/BCOP) can be nearly eliminated if new formulations are systematically compared to those previously tested using a defined decision tree. For other tested product categories, new formulations should continue to be evaluated in CAMVA/BCOP for ocular irritation potential because either the historical data exhibit significant variability (hair conditioners and mousses) or the historical sample size is too small to permit definitive conclusions (deodorants, make-up removers, massage oils, facial masks, body sprays, and other hair styling products). All decision tree conclusions should be made within a conservative weight-of-evidence context, considering the reported limitations of the BCOP test for alcohols, ketones, and solids. Copyright © 2010 Elsevier Ltd. All rights reserved.

  6. Predictive performance of the Vitrigel‐eye irritancy test method using 118 chemicals

    PubMed Central

    Yamaguchi, Hiroyuki; Kojima, Hajime

    2015-01-01

    Abstract We recently developed a novel Vitrigel‐eye irritancy test (EIT) method. The Vitrigel‐EIT method is composed of two parts, i.e., the construction of a human corneal epithelium (HCE) model in a collagen vitrigel membrane chamber and the prediction of eye irritancy by analyzing the time‐dependent profile of transepithelial electrical resistance values for 3 min after exposing a chemical to the HCE model. In this study, we estimated the predictive performance of Vitrigel‐EIT method by testing a total of 118 chemicals. The category determined by the Vitrigel‐EIT method in comparison to the globally harmonized system classification revealed that the sensitivity, specificity and accuracy were 90.1%, 65.9% and 80.5%, respectively. Here, five of seven false‐negative chemicals were acidic chemicals inducing the irregular rising of transepithelial electrical resistance values. In case of eliminating the test chemical solutions showing pH 5 or lower, the sensitivity, specificity and accuracy were improved to 96.8%, 67.4% and 84.4%, respectively. Meanwhile, nine of 16 false‐positive chemicals were classified irritant by the US Environmental Protection Agency. In addition, the disappearance of ZO‐1, a tight junction‐associated protein and MUC1, a cell membrane‐spanning mucin was immunohistologically confirmed in the HCE models after exposing not only eye irritant chemicals but also false‐positive chemicals, suggesting that such false‐positive chemicals have an eye irritant potential. These data demonstrated that the Vitrigel‐EIT method could provide excellent predictive performance to judge the widespread eye irritancy, including very mild irritant chemicals. We hope that the Vitrigel‐EIT method contributes to the development of safe commodity chemicals. Copyright © 2015 The Authors. Journal of Applied Toxicology published by John Wiley & Sons Ltd. PMID:26472347

  7. Predictive performance of the Vitrigel-eye irritancy test method using 118 chemicals.

    PubMed

    Yamaguchi, Hiroyuki; Kojima, Hajime; Takezawa, Toshiaki

    2016-08-01

    We recently developed a novel Vitrigel-eye irritancy test (EIT) method. The Vitrigel-EIT method is composed of two parts, i.e., the construction of a human corneal epithelium (HCE) model in a collagen vitrigel membrane chamber and the prediction of eye irritancy by analyzing the time-dependent profile of transepithelial electrical resistance values for 3 min after exposing a chemical to the HCE model. In this study, we estimated the predictive performance of Vitrigel-EIT method by testing a total of 118 chemicals. The category determined by the Vitrigel-EIT method in comparison to the globally harmonized system classification revealed that the sensitivity, specificity and accuracy were 90.1%, 65.9% and 80.5%, respectively. Here, five of seven false-negative chemicals were acidic chemicals inducing the irregular rising of transepithelial electrical resistance values. In case of eliminating the test chemical solutions showing pH 5 or lower, the sensitivity, specificity and accuracy were improved to 96.8%, 67.4% and 84.4%, respectively. Meanwhile, nine of 16 false-positive chemicals were classified irritant by the US Environmental Protection Agency. In addition, the disappearance of ZO-1, a tight junction-associated protein and MUC1, a cell membrane-spanning mucin was immunohistologically confirmed in the HCE models after exposing not only eye irritant chemicals but also false-positive chemicals, suggesting that such false-positive chemicals have an eye irritant potential. These data demonstrated that the Vitrigel-EIT method could provide excellent predictive performance to judge the widespread eye irritancy, including very mild irritant chemicals. We hope that the Vitrigel-EIT method contributes to the development of safe commodity chemicals. Copyright © 2015 The Authors. Journal of Applied Toxicology published by John Wiley & Sons Ltd. Copyright © 2015 The Authors. Journal of Applied Toxicology published by John Wiley & Sons Ltd.

  8. Vitrigel-eye irritancy test method using HCE-T cells.

    PubMed

    Yamaguchi, Hiroyuki; Kojima, Hajime; Takezawa, Toshiaki

    2013-10-01

    We previously reported that the time-dependent relative changes of transepithelial electrical resistance (TEER) after exposing four different chemicals to a human corneal epithelium (HCE) model were well correlated to the potential of ocular irritancy. Meanwhile, we recently developed a collagen vitrigel membrane (CVM) chamber possessing a scaffold composed of high-density collagen fibrils equivalent to connective tissues in vivo as a three-dimensional culture tool. The CVM chamber is useful for biomedical assays and immunohistology using cryosections that are inappropriate to be performed using the conventional Millicell chamber with a polyethylene terephthalate membrane. In this study, we aimed to develop a new eye irritancy test (EIT) method called "Vitrigel-EIT method" that can facilitate to briefly and accurately estimate the widespread irritancy of test chemicals by applying the TEER assay system to a HCE model fabricated in the CVM chamber. HCE-T cells (a HCE-derived cell strain) were cultured in the CVM chamber for 6 days, and consequently, the Vitrigel-HCE model possessing the following characteristics of HCE in vivo was formed: six cell layers with specific protein expressions and their barrier function. Time-dependent profiles of TEER values after exposing 30 test chemicals to the HCE model were converted into the scores of three indexes (time lag, intensity, and plateau level), and each chemical was successfully classified into irritant or nonirritant category by utilizing the criteria for the indexes, resulting in the excellent correlation with Globally Harmonized System of Classification and Labelling of Chemicals (GHS) classification (sensitivity: 100%, specificity: 75%, accuracy: 90%). These data suggest that the widespread eye irritancy of chemicals can be predicted without false negatives by the Vitrigel-EIT method. Interestingly, the disruption of tight junctions was immunohistologically observed after exposing not only irritants but also three

  9. CON4EI: Slug Mucosal Irritation (SMI) test method for hazard identification and labelling of serious eye damaging and eye irritating chemicals.

    PubMed

    Adriaens, E; Guest, R; Willoughby, J A; Fochtman, P; Kandarova, H; Verstraelen, S; Van Rompay, A R

    2018-06-01

    Assessment of ocular irritancy is an international regulatory requirement in the safety evaluation of industrial and consumer products. Although many in vitro ocular irritation assays exist, alone they are incapable of fully categorizing chemicals. The objective of CEFIC-LRI-AIMT6-VITO CON4EI (CONsortium for in vitro Eye Irritation testing strategy) project was to develop tiered testing strategies for eye irritation assessment that can lead to complete replacement of the in vivo Draize rabbit eye test (OECD TG 405). A set of 80 reference chemicals was tested with seven test methods, one method was the Slug Mucosal Irritation (SMI) test method. The method measures the amount of mucus produced (MP) during a single 1-hour contact with a 1% and 10% dilution of the chemical. Based on the total MP, a classification (Cat 1, Cat 2, or No Cat) is predicted. The SMI test method correctly identified 65.8% of the Cat 1 chemicals with a specificity of 90.5% (low over-prediction rate for in vivo Cat 2 and No Cat chemicals). Mispredictions were predominantly unidirectional towards lower classifications with 26.7% of the liquids and 40% of the solids being underpredicted. In general, the performance was better for liquids than for solids with respectively 76.5% vs 57.1% (Cat 1), 61.5% vs 50% (Cat 2), and 87.5% vs 85.7% (No Cat) being identified correctly. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Characterization of new eye drops with choline salicylate and assessment of their irritancy by in vitro short time exposure tests.

    PubMed

    Wroblewska, Katarzyna; Kucinska, Małgorzata; Murias, Marek; Lulek, Janina

    2015-09-01

    The aim of our study was to examine the irritation potential of new eye drops containing 2% choline salicylate (CS) as an active pharmaceutical ingredient (API) and various polymers increasing eye drop viscosity (hydroxyethylcellulose, hydroxypropyl methylcellulose, methylcellulose, polyvinyl alcohol, polyvinylpyrrolidone). The standard method for assessing the potential of irritating substances has been the Draize rabbit eye test. However the European Centre for Validation of Alternative Methods and the Coordinating Committee for Validation of Alternative Methods recommend, short time exposure (STE) in vitro tests as an alternative method for assessing eye irritation. The eye irritation potential was determined using cytotoxicity test methods for rabbit corneal cell line (SIRC) after 5 min exposure. The viability of cells was determined using two cytotoxicity assays: MTT and Neutral Red Uptake. According to the irritation rankings for the short time exposure test, all tested eye drops are classified as non-irritating (cell viability >70%).

  11. Characterization of new eye drops with choline salicylate and assessment of their irritancy by in vitro short time exposure tests

    PubMed Central

    Wroblewska, Katarzyna; Kucinska, Małgorzata; Murias, Marek; Lulek, Janina

    2014-01-01

    The aim of our study was to examine the irritation potential of new eye drops containing 2% choline salicylate (CS) as an active pharmaceutical ingredient (API) and various polymers increasing eye drop viscosity (hydroxyethylcellulose, hydroxypropyl methylcellulose, methylcellulose, polyvinyl alcohol, polyvinylpyrrolidone). The standard method for assessing the potential of irritating substances has been the Draize rabbit eye test. However the European Centre for Validation of Alternative Methods and the Coordinating Committee for Validation of Alternative Methods recommend, short time exposure (STE) in vitro tests as an alternative method for assessing eye irritation. The eye irritation potential was determined using cytotoxicity test methods for rabbit corneal cell line (SIRC) after 5 min exposure. The viability of cells was determined using two cytotoxicity assays: MTT and Neutral Red Uptake. According to the irritation rankings for the short time exposure test, all tested eye drops are classified as non-irritating (cell viability >70%). PMID:27134543

  12. Investigation of the predictive validity of laser-EPs in normal, UVB-inflamed and capsaicin-irritated skin with four analgesic compounds in healthy volunteers.

    PubMed

    Schaffler, Klaus; Nicolas, Laurent B; Borta, Andreas; Brand, Tobias; Reitmeir, Peter; Roebling, Robert; Scholpp, Joachim

    2017-07-01

    The aim of the present study was to assess the predictivity of laser-(radiant-heat)-evoked potentials (LEPs) from the vertex electroencephalogram, using an algesimetric procedure, testing the anti-nociceptive/anti-hyperalgesic effects of single oral doses of four marketed analgesics (of different compound classes) vs. placebo, in healthy volunteers with three skin types. This was a randomized, placebo-controlled, single-blind, five-way-crossover trial. Twenty-five healthy male/female Caucasians were included (receiving celecoxib 200 mg, pregabalin 150 mg, duloxetine 60 mg, lacosamide 100 mg or placebo) in a Williams design, with CO 2 laser-induced painful stimuli to normal, ultraviolet (UV) B-inflamed and capsaicin-irritated skin. LEPs and visual analogue scale ratings were taken at baseline and hourly for 6 h postdose from all three skin types. In normal skin, the averaged postdose LEP peak-to-peak-(PtP)-amplitudes were reduced by pregabalin (-2.68 μV; 95% confidence interval (CI) -4.16, 1.19) and duloxetine (-1.73 μV; 95% CI -3.21, -0.26) but not by lacosamide and celecoxib vs. placebo. On UVB-irradiated skin, reflecting inflammatory pain, celecoxib induced a pronounced reduction in LEP PtP amplitudes vs. placebo (-6.2 μV; 95% CI -7.88, -4.51), with a smaller reduction by duloxetine (-4.54 μV; 95% CI -6.21, -2.87) and pregabalin (-3.72 μV; 95% CI -5.40, -2.04), whereas lacosamide was inactive. LEP PtP amplitudes on capsaicin-irritated skin, reflecting peripheral/spinal sensitization, as in neuropathic pain, were reduced by pregabalin (-3.78 μV; 95% CI -5.31, -2.25) and duloxetine (-2.32 μV; 95% CI -3.82, -0.82) but not by celecoxib or lacosamide vs. placebo, which was in agreement with known clinical profiles. Overall, PtP amplitude reductions were in agreement with subjective ratings. LEP algesimetry is sensitive to analgesics with different modes of action and may enable the effects of novel analgesics to be assessed during early clinical

  13. Effects of JP-8 on Molecular and Histological Parameters Related to Acute Skin Irritation

    DTIC Science & Technology

    2000-06-01

    in irritant dermatitis are understood. Cytokines are cell signaling molecules that are involved in the inflammatory response. These include the...are involved in inflammatory responses in contact dermatitis (Figure 2, Ormerod et al., 1997). The analysis of iNOS mRNA or protein, as well as the...placed into a Bessman steel tissue pulverizer (Fisher Scientific, Cat # 08-418-2) that was pre-chilled in liquid nitrogen. Using a lead hammer

  14. CON4EI: EpiOcular™ Eye Irritation Test (EpiOcular™ EIT) for hazard identification and labelling of eye irritating chemicals.

    PubMed

    Kandarova, H; Letasiova, S; Adriaens, E; Guest, R; Willoughby, J A; Drzewiecka, A; Gruszka, K; Alépée, Nathalie; Verstraelen, Sandra; Van Rompay, An R

    2018-06-01

    Assessment of the acute eye irritation potential is part of the international regulatory requirements for testing of chemicals. The objective of the CON4EI project was to develop tiered testing strategies for eye irritation assessment. A set of 80 reference chemicals (38 liquids and 42 solids) was tested with eight different methods. Here, the results obtained with the EpiOcular™ Eye Irritation Test (EIT), adopted as OECD TG 492, are shown. The primary aim of this study was to evaluate of the performance of the test method to discriminate between chemicals not requiring classification for serious eye damage/eye irritancy (No Category) and chemicals requiring classification and labelling. In addition, the predictive capacity in terms of in vivo drivers of classification (i.e. corneal opacity, conjunctival redness and persistence at day 21) was investigated. EpiOcular™ EIT achieved a sensitivity of 97%, a specificity of 87% and accuracy of 95% and also confirmed its excellent reproducibility (100%) from the original validation. The assay was applicable to all chemical categories tested in this project and its performance was not limited to the particular driver of the classification. In addition to the existing prediction model for dichotomous categorization, a new prediction model for Cat 1 is suggested. Copyright © 2017. Published by Elsevier Ltd.

  15. Managing Occupational Irritant Contact Dermatitis Using a Two-Step Skincare Regimen Designed to Prevent Skin Damage and Support Skin Recovery.

    PubMed

    von Grote, Erika C; Palaniswarmy, Kiruthi; Meckfessel, Matthew H

    2016-12-01

    Occupational irritant contact dermatitis (ICD) affecting the hands is a common and difficult-to-manage condition. Occupations that necessitate contact with harsh chemicals, use of alcohol-based disinfectants, and frequent hand washing elevate the risk of ICD. Management strategies that do not adequately prevent accumulated damage and repair skin, can develop into chronic dermatoses which negatively impact work productivity and quality of life. A 2-step skin-care regimen (Excipial Daily Protection Hand Cream (EP) and Excipial Rapid Repair Hand Cream (ER), Galderma Laboratories, L.P.) has been developed as a daily-use management strategy to protect and repair vulnerable hands. The protective barrier cream is formulated with aluminum chlorohydrate and designed for pre-exposure application to enhance the skin's natural protective barrier and minimize excessive moisture while wearing protective gloves. The repair cream, a lipid-rich formulation, is intended for post-exposure application to rehydrate and facilitate the skin's natural healing process. The results of 3 clinical studies highlighted in this review demonstrate how the use of a 2-step skin-care regimen offers a greater protective effect against ICD than the use of barrier cream alone, and also how the formulation of the barrier cream used in these studies helps minimize the occlusion effect caused by gloves and does not interfere with the antibacterial efficacy of an alcohol-based hand sanitizer. This 2-step skin-care regimen is effectively designed to manage and minimize the risk of ICD development in a variety of patients and provides clinicians an additional tool for helping patients manage ICD. J Drugs Dermatol. 2016;15(12):1504-1510.

  16. Novel isotretinoin microemulsion-based gel for targeted topical therapy of acne: formulation consideration, skin retention and skin irritation studies

    NASA Astrophysics Data System (ADS)

    Patel, Mrunali R.; Patel, Rashmin B.; Parikh, Jolly R.; Patel, Bharat G.

    2016-04-01

    Isotretinoin was formulated in novel microemulsion-based gel formulation with the aim of improving its solubility, skin tolerability, therapeutic efficacy, skin-targeting efficiency and patient compliance. Microemulsion was formulated by the spontaneous microemulsification method using 8 % isopropyl myristate, 24 % Labrasol, 8 % plurol oleique and 60 % water as an external phase. All plain and isotretinoin-loaded microemulsions were clear and showed physicochemical parameters for the desired topical delivery and stability. The permeation profiles of isotretinoin through rat skin from selected microemulsion formulation followed zero-order kinetics. Microemulsion-based gel was prepared by incorporating Carbopol®971 in optimized microemulsion formulation having suitable skin permeation rate and skin uptake. Microemulsion-based gel showed desired physicochemical parameters and demonstrated advantage over marketed formulation in improving the skin tolerability of isotretinoin, indicating its potential in improving topical delivery of isotretinoin. The developed microemulsion-based gel may be a potential drug delivery vehicle for targeted topical delivery of isotretinoin in the treatment of acne.

  17. Measurement of cytotoxicity and irritancy potential of sugar-based surfactants on skin-related 3D models.

    PubMed

    Lu, Biao; Miao, Yong; Vigneron, Pascale; Chagnault, Vincent; Grand, Eric; Wadouachi, Anne; Postel, Denis; Pezron, Isabelle; Egles, Christophe; Vayssade, Muriel

    2017-04-01

    Sugar-based surfactants present surface-active properties and relatively low cytotoxicity. They are often considered as safe alternatives to currently used surfactants in cosmetic industries. In this study, four sugar-based surfactants, each with an eight carbon alkyl chain bound to a glucose or a maltose headgroup through an amide linkage, were synthesized and compared to two standard surfactants. The cytotoxic and irritant effects of surfactants were evaluated using two biologically relevant models: 3D dermal model (mouse fibroblasts embedded in collagen gel) and reconstituted human epidermis (RHE, multi-layered human keratinocytes). Results show that three synthesized surfactants possess lower cytotoxicity compared to standard surfactants as demonstrated in the 3D dermal model. Moreover, the IC50s of surfactants against the 3D dermal model are higher than IC50s obtained with the 2D dermal model (monolayer mouse fibroblasts). Both synthesized and standard surfactants show no irritant effects after 48h of topical application on RHE. Throughout the study, we demonstrate the difficulty to link the physico-chemical properties of surfactants and their cytotoxicity in complex models. More importantly, our data suggest that, prior to in vivo tests, a complete understanding of surfactant cytotoxicity or irritancy potential requires a combination of cellular and tissue models. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. Skin corrosion test: a comparison between reconstructed human epidermis and full thickness skin models.

    PubMed

    Catarino, Carolina Motter; do Nascimento Pedrosa, Tatiana; Pennacchi, Paula Comune; de Assis, Silvia Romano; Gimenes, Fabrícia; Consolaro, Márcia Edilaine Lopes; de Moraes Barros, Silvia Berlanga; Maria-Engler, Silvya Stuchi

    2018-04-01

    Currently, there is a strong global trend towards the development of in vitro models to replace the use of animals in safety evaluation tests. Reconstructed Human Epidermis (RHE) models have been employed as an alternative method to animal testing of skin corrosion and irritation potential of chemical compounds. However, the consequences of an absence of the dermal compartment in these models should be considered since the cross-talk between fibroblasts and keratinocytes is fundamental for promoting proper epidermal stratification, homeostasis, inflammatory response and wound healing. In this study, we compare in-house developed models of Reconstructed Human Epidermis (i.e. USP-RHE) and full thickness skin (i.e. USP-FTS) regarding their response when submitted to skin corrosion assays, based on Guideline 431 (OECD). The results show that both models correctly classified the four substances tested (2-phenylethyl bromide, benzylacetone, lactic acid, octanoic acid) as corrosive or non-corrosive. Furthermore, we have demonstrated higher cell viability of the USP-FTS model compared to the USP-RHE model, a sign of its improved barrier function, following the exposure to the substances test on the corrosion assay. This emphasizes the importance of employing in vitro models that are more physiologically relevant and that better mimic the in vivo situation for the toxicological screening of substances. Copyright © 2018 Elsevier B.V. All rights reserved.

  19. Validation of artificial skin equivalents as in vitro testing systems

    NASA Astrophysics Data System (ADS)

    Schmitt, Robert; Marx, Ulrich; Walles, Heike; Schober, Lena

    2011-03-01

    With the increasing complexity of the chemical composition of pharmaceuticals, cosmetics and everyday substances, the awareness of potential health issues and long term damages for humanoid organs is shifting into focus. Artificial in vitro testing systems play an important role in providing reliable test conditions and replacing precarious animal testing. Especially artificial skin equivalents ASEs are used for a broad spectrum of studies like penetration, irritation and corrosion of substances. One major challenge in tissue engineering is the qualification of each individual ASE as in vitro testing system. Due to biological fluctuations, the stratum corneum hornified layer of some ASEs may not fully develop or other defects might occur. For monitoring these effects we developed an fully automated Optical Coherence Tomography device. Here, we present different methods to characterize and evaluate the quality of the ASEs based on image and data processing of OCT B-scans. By analysing the surface structure, defects, like cuts or tears, are detectable. A further indicator for the quality of the ASE is the morphology of the tissue. This allows to determine if the skin model has reached the final growth state. We found, that OCT is a well suited technology for automatically characterizing artificial skin equivalents and validating the application as testing system.

  20. 16 CFR 1500.42 - Test for eye irritants.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... noted below. (2) The eyes are examined and the grade of ocular reaction is recorded at 24, 48, and 72 hours. Reading of reactions is facilitated by use of a binocular loupe, hand slit-lamp, or other expert... positive reaction if the test substance produces at any of the readings ulceration of the cornea (other...

  1. Effect of different alcohols on stratum corneum kallikrein 5 and phospholipase A2 together with epidermal keratinocytes and skin irritation.

    PubMed

    Cartner, T; Brand, N; Tian, K; Saud, A; Carr, T; Stapleton, P; Lane, M E; Rawlings, A V

    2017-04-01

    The aim of this exploratory study was to investigate the effect of ethanol, isopropanol and n-propanol on stratum corneum (SC) enzymes and keratinocytes in vitro together with their effects on skin condition and function. Activities of kallikrein 5 (KLK5) and phospholipase A2 (PLA2) as well as keratinocyte metabolic activity, interleukin-1α (IL-1α) and tumor necrosis factor-α (TNF-α) were measured in vitro in the presence and absence of the different alcohols. We also measured transepidermal water loss (TEWL), skin capacitance, visual dryness and visual redness on the volar forearms of 25 Caucasian women following application of the alcohols 20 and 100 times per day over a period of 14 days in a clinical study. Reduced activities of KLK5 and PLA2 were observed in the presence of the alcohols. The greatest denaturing effect was always observed for n-propanol (P < 0.001), and in the case of PLA2, the effect of isopropanol was greater than ethanol (P < 0.001). Equally, ethanol had the mildest effects on keratinocyte metabolic activity and cytokine secretion (P < 0.001) and n-propanol always produced the most severe changes in normal and differentiated keratinocytes. These in vitro findings supported the clinical results where the major effects were on the induction of skin irritation (increased dropout rates) and ranked the intolerance of the different alcohols as follows: n-propanol > isopropanol > ethanol. At the high application frequencies, the effect of the different alcohols on transepidermal water loss (TEWL) and skin capacitance was similar, but at the low application frequencies, n-propanol had a significant effect on TEWL and capacitance values (P < 0.05). Equally, n-propanol and isopropanol produced significantly more skin redness at the low application frequencies. Clearly, isopropanol and n-propanol caused significant SC and keratinocyte perturbation in vitro together with damage to skin condition and function in vivo whereas ethanol

  2. Use of the cytosensor microphysiometer to predict results of a 21-day cumulative irritation patch test in humans.

    PubMed

    Landin, Wendell E; Mun, Greg C; Nims, Raymond W; Harbell, John W

    2007-09-01

    The cytosensor microphysiometer (mu phi) was investigated as a rapid, relatively inexpensive test to predict performance of skin cleansing wipes on the human 21-day cumulative irritation patch test (21CIPT). It indirectly measures metabolic rate changes in L929 cells as a function of test article dose, by measuring the acidification rate in a low-buffer medium. The dose producing a 50% reduction in metabolic rate (MRD50), relative to the baseline rate, is used as a measure of toxicity. The acute toxicity of the mu phi assay can be compared to the chronic toxicity of the 21CIPT, which is based largely on the exposure of test agents to the epidermal cells, resulting in damage and penetration of the stratum corneum leading to cell toxicity. Two series of surfactant-based cleansing wipe products were tested via the mu phi assay and 21CIPT. The first series, consisting of 20 products, was used to determine a prediction model. The second series of 38 products consisted of routine product development formulas or marketed products. Comparing the results from both tests, samples with an MRD50 greater than 50 mg/ml provided a 21CIPT score consistent with a product that performs satisfactorily in the market. When the MRD50 was greater than 78 mg/ml, the 21CIPT score was usually zero. The mu phi may be more sensitive than the 21CIPT for ranking minimally irritating materials. The mu phi assay is useful as a screen for predicting the performance of a wet wipes formula on the 21CIPT, and concurrently reduces the use of animals for safety testing in a product development program for cleansing wipes.

  3. The three moments of skin cream application: an evidence-based proposal for use of skin creams in the prevention of irritant contact dermatitis in the workplace.

    PubMed

    Hines, J; Wilkinson, S M; John, S M; Diepgen, T L; English, J; Rustemeyer, T; Wassilew, S; Kezic, S; Maibach, H I

    2017-01-01

    Contact dermatitis is one of the most common occupational diseases, with serious impact on quality of life, lost days at work and a condition that may be chronically relapsing. Regular prophylactic skin cream application is widely acknowledged to be an effective prevention strategy against occupational contact dermatitis; however, compliance rates remain low. To present a simple programme for skin cream application in the workplace with focus on implementation to drive down the rate of occupational irritant contact dermatitis, an expert panel of eight international dermatologists combined personal experience with extensive literature review. The recommendations are based on clinical experience as supported by evidence-based data from interventional studies. The authors identified three moments for skin cream application in the work place: (i) before starting a work period; (ii) after washing hands; and (iii) after work. Affecting behaviour change requires systematic communications, monitoring and reporting, which is proposed through Kotter's principles of organizational change management. Measurement tools are provided in the appendix. Interventional data based on application of this proposal is required to demonstrate its effectiveness. © 2016 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.

  4. Biocompatible microemulsions of a model NSAID for skin delivery: A decisive role of surfactants in skin penetration/irritation profiles and pharmacokinetic performance.

    PubMed

    Todosijević, Marija N; Savić, Miroslav M; Batinić, Bojan B; Marković, Bojan D; Gašperlin, Mirjana; Ranđelović, Danijela V; Lukić, Milica Ž; Savić, Snežana D

    2015-12-30

    To elaborate the decisive role of surfactants in promotion of aceclofenac' skin absorption, potentially avoiding irritation, we developed non-ionic microemulsions varying natural or synthetic surfactants: sucrose esters (laurate or myristate) vs. polysorbate 80. A comprehensive physicochemical characterization indicated no significant influence of the solubilized nonsteroidal anti-inflammatory drug on the bicontinuous structure of blank formulations. To evaluate skin tolerability of isopropyl alcohol, a sucrose ester-based microemulsion containing transcutol P as a cosurfactant was also developed. The measured skin parameters strongly depended on the (co)surfactant type, showing higher compatibility of the microemulsions containing sucrose ester and isopropyl alcohol. In vitro release results, in vivo tape stripping and pharmacokinetics in rats confirmed superiority of the sucrose ester- over polysorbate-based microemulsions (total amounts of aceclofenac penetrated 60.81±5.97 and 60.86±3.67 vs. 27.00±5.09μg/cm(2), and its maximum plasma concentrations 275.57±109.49 and 281.31±76.76 vs. 150.23±69.74ng/ml for sucrose laurate- and myristate- vs. polysorbate 80-based microemulsions, respectively). Hence, sugar-based excipients increased delivery of aceclofenac through stratum corneum by increasing its fluidity, showing overall more satisfying safety profiles. In conclusion, sucrose ester-based microemulsions proved to be promising carriers for dermal/transdermal aceclofenac delivery. Copyright © 2015 Elsevier B.V. All rights reserved.

  5. The EpiOcular™ Eye Irritation Test is the Method of Choice for the In Vitro Eye Irritation Testing of Agrochemical Formulations: Correlation Analysis of EpiOcular Eye Irritation Test and BCOP Test Data According to the UN GHS, US EPA and Brazil ANVISA Classification Schemes.

    PubMed

    Kolle, Susanne N; Rey Moreno, Maria Cecilia; Mayer, Winfried; van Cott, Andrew; van Ravenzwaay, Bennard; Landsiedel, Robert

    2015-07-01

    The Bovine Corneal Opacity and Permeability (BCOP) test is commonly used for the identification of severe ocular irritants (GHS Category 1), but it is not recommended for the identification of ocular irritants (GHS Category 2). The incorporation of human reconstructed tissue model-based tests into a tiered test strategy to identify ocular non-irritants and replace the Draize rabbit eye irritation test has been suggested (OECD TG 405). The value of the EpiOcular™ Eye Irritation Test (EIT) for the prediction of ocular non-irritants (GHS No Category) has been demonstrated, and an OECD Test Guideline (TG) was drafted in 2014. The purpose of this study was to evaluate whether the BCOP test, in conjunction with corneal histopathology (as suggested for the evaluation of the depth of the injury( and/or the EpiOcular-EIT, could be used to predict the eye irritation potential of agrochemical formulations according to the UN GHS, US EPA and Brazil ANVISA classification schemes. We have assessed opacity, permeability and histopathology in the BCOP assay, and relative tissue viability in the EpiOcular-EIT, for 97 agrochemical formulations with available in vivo eye irritation data. By using the OECD TG 437 protocol for liquids, the BCOP test did not result in sufficient correct predictions of severe ocular irritants for any of the three classification schemes. The lack of sensitivity could be improved somewhat by the inclusion of corneal histopathology, but the relative viability in the EpiOcular-EIT clearly outperformed the BCOP test for all three classification schemes. The predictive capacity of the EpiOcular-EIT for ocular non-irritants (UN GHS No Category) for the 97 agrochemical formulations tested (91% sensitivity, 72% specificity and 82% accuracy for UN GHS classification) was comparable to that obtained in the formal validation exercise underlying the OECD draft TG. We therefore conclude that the EpiOcular-EIT is currently the best in vitro method for the prediction

  6. International regulatory requirements for skin sensitization testing.

    PubMed

    Daniel, Amber B; Strickland, Judy; Allen, David; Casati, Silvia; Zuang, Valérie; Barroso, João; Whelan, Maurice; Régimbald-Krnel, M J; Kojima, Hajime; Nishikawa, Akiyoshi; Park, Hye-Kyung; Lee, Jong Kwon; Kim, Tae Sung; Delgado, Isabella; Rios, Ludmila; Yang, Ying; Wang, Gangli; Kleinstreuer, Nicole

    2018-06-01

    Skin sensitization test data are required or considered by chemical regulation authorities around the world. These data are used to develop product hazard labeling for the protection of consumers or workers and to assess risks from exposure to skin-sensitizing chemicals. To identify opportunities for regulatory uses of non-animal replacements for skin sensitization tests, the needs and uses for skin sensitization test data must first be clarified. Thus, we reviewed skin sensitization testing requirements for seven countries or regions that are represented in the International Cooperation on Alternative Test Methods (ICATM). We noted the type of skin sensitization data required for each chemical sector and whether these data were used in a hazard classification, potency classification, or risk assessment context; the preferred tests; and whether alternative non-animal tests were acceptable. An understanding of national and regional regulatory requirements for skin sensitization testing will inform the development of ICATM's international strategy for the acceptance and implementation of non-animal alternatives to assess the health hazards and risks associated with potential skin sensitizers. Copyright © 2018 Elsevier Inc. All rights reserved.

  7. A new 3D reconstituted human corneal epithelium model as an alternative method for the eye irritation test.

    PubMed

    Jung, Kyoung-Mi; Lee, Su-Hyon; Ryu, Yang-Hwan; Jang, Won-Hee; Jung, Haeng-Sun; Han, Ju-Hee; Seok, Seung-Hyeok; Park, Jae-Hak; Son, Youngsook; Park, Young-Ho; Lim, Kyung-Min

    2011-02-01

    Many efforts are being made to develop new alternative in vitro test methods for the eye irritation test. Here we report a new reconstructed human corneal epithelial model (MCTT HCE model) prepared from primary-cultured human limbal epithelial cells as a new alternative in vitro eye irritation test method. In histological and immunohistochemical observation, MCTT HCE model displayed a morphology and biomarker expressions similar to intact human cornea. Moreover, the barrier function was well preserved as measured by high transepithelial electrical resistance, effective time-50 for Triton X-100, and corneal thickness. To employ the model as a new alternative method for eye irritation test, protocol refinement was performed and optimum assay condition was determined including treatment time, treatment volume, post-incubation time and rinsing method. Using the refined protocol, 25 reference chemicals with known eye irritation potentials were tested. With the viability cut-off value at 50%, chemicals were classified to irritant or non-irritant. When compared with GHS classification, the MCTT HCE model showed the accuracy of 88%, sensitivity of 100% and specificity of 77%. These results suggest that the MCTT HCE model might be useful as a new alternative eye irritation test method. Copyright © 2010 Elsevier Ltd. All rights reserved.

  8. The irritation potential and reservoir effect of mild soaps.

    PubMed

    Lodén, Marie; Buraczewska, Izabela; Edlund, Fredrik

    2003-08-01

    Identification and reduction of external noxious factors is one key point in the strategy for the treatment and reduction of contact dermatitis. A wide variety of soaps on the market are claimed to be suitable for the use on sensitive skin due to their mildness. The aim of the present study was to illustrate possible differences in the irritation potential of 8 products and to investigate whether surfactant residues may form an irritant reservoir on the skin. The study was double-blind, randomized using healthy human volunteers. The inherent capacity of the products to induce irritation was determined using conventional patch test technique, whereas detection of potential surfactant residues on the skin was done using a methodology developed in the 1960s for detection of the corticosteroid reservoir in the stratum corneum. The method comprised the release of active substance from the stratum corneum reservoir by occlusion of the skin with an aluminium chamber, followed by evaluation of the biological response. In the present study, the soap-treated area was rinsed with water and then occluded. Instrumental measurements of the transepidermal water loss and superficial skin blood flow served as indicators of the injurious effects of the products. The results showed large differences in irritation potential between the products, and some of them demonstrated considerable damaging effect. Moreover, the study proved the presence of barrier-impairing residues on the skin after rinsing with water. Subclinical skin damage can make the skin vulnerable to further irritation and delay recovery of chronic irritant contact dermatitis.

  9. Epidermal-skin-test 1,000 (EST-1,000)--a new reconstructed epidermis for in vitro skin corrosivity testing.

    PubMed

    Hoffmann, J; Heisler, E; Karpinski, S; Losse, J; Thomas, D; Siefken, W; Ahr, H-J; Vohr, H-W; Fuchs, H W

    2005-10-01

    The determination of a possible corrosive or irritative potential of certain products and ingredients is necessary for their classification and labeling requirements. Reconstructed skin as a model system provides fundamental advantages to single cell culture testing and leads to promising results as shown by different validation studies (for review: Fentem, J.H., Botham, P.A., 2002. ECVAM's activities in validating alternative tests for skin corrosion and irritation. ATLA 30(Suppl. 2), 61-67). In this study we introduce our new reconstructed epidermis "Epidermal-Skin-Test" (EST-1,000). This fully grown epidermis consists of proliferating as well as differentiating keratinocytes. EST-1,000 shows a high comparability to normal human skin as shown by histological and immunohistochemical data. Characteristic markers (KI-67, CK 1/10/5/14, transglutaminase, collagen IV, involucrin, beta 1 integrin) can be identified easily. The main focus of this work was to characterize EST-1,000 especially with respect to its barrier function by testing several substances of known corrosive potential. Skin corrosion was detected by the cytotoxic effect of the substances on a reconstructed epidermis after short-term application to the stratum corneum. The effect was determined by standard MTT assay and accompanying histological analysis. Hence EST-1,000 shows a very high predictive potential and closes the gap between animal testing and the established full-thickness model Advanced-Skin-Test 2,000 (AST-2,000) (Noll, M., Merkle, M.-L., Kandsberger, M., Matthes, T., Fuchs, H., Graeve, T., 1999. Reconstructed human skin (AST-2,000) as a tool for pharmaco-toxicology. ATLA 27, 302).

  10. Norartocarpetin from a folk medicine Artocarpus communis plays a melanogenesis inhibitor without cytotoxicity in B16F10 cell and skin irritation in mice

    PubMed Central

    2013-01-01

    Background Many natural products used in preventive medicine have also been developed as cosmeceutical ingredients in skin care products, such as Scutellaria baicalensis and Gardenia jasminoides. Norartocarpetin is one of the antioxidant and antityrosinase activity compound in Artocarpus communis; however, the cytotoxicity, skin irritation and antimelanogenesis mechanisms of norartocarpetin have not been investigated yet. Methods In the present study, cell viability in vitro and skin irritation in vivo are used to determine the safety of norartocarpetin. The melanogenesis inhibition of norartocarpetin was determined by cellular melanin content and tyrosinase in B16F10 melanoma cell. Moreover, we examined the related-melanogenesis protein by western blot analysis for elucidating the antimelanogenesis mechanism of norartocarpin. Results The result of the present study demonstrated that norartocarpetin not only present non-cytotoxic in B16F10 and human fibroblast cells but also non-skin irritation in mice. Moreover, our result also first found that norartocarpetin downregulated phospho-cAMP response element-binding (phospho-CREB) and microphthalmia-associated transcription factor (MITF) expression, which in turn decreased both synthesis of tyrosinases (TRP-1 and TRP-2) and cellular melanin content. This process is dependent on norartocarpetin phosphorylation by mitogen-activated protein kinases such as phospho-JNK and phospho-p38, and it results in decreased melanogenesis. Conclusion The present study suggests that norartocarpetin could be used as a whitening agent in medicine and/or cosmetic industry and need further clinical study. PMID:24325567

  11. Oral administration of glucosylceramide ameliorates inflammatory dry-skin condition in chronic oxazolone-induced irritant contact dermatitis in the mouse ear.

    PubMed

    Yeom, Mijung; Kim, Sung-Hun; Lee, Bombi; Han, Jeong-Jun; Chung, Guk Hoon; Choi, Hee-Don; Lee, Hyejung; Hahm, Dae-Hyun

    2012-08-01

    Irritant contact dermatitis (ICD) is an inflammatory skin disease triggered by exposure to a chemical that is toxic or irritating to the skin. A major characteristic of chronic ICD is an inflammatory dry-skin condition with associated itching. Although glucosylceramide (GlcCer) is known to improve the skin barrier function, its mechanism of action is unknown. Using a mouse model of oxazolone-induced chronic ICD, this study investigated the effects of oral administration of GlcCer on inflammatory dry skin. Chronic ICD was induced by repeated application of oxazolone in mice. GlcCer was orally administered once daily throughout the elicitation phase. The beneficial efficacy of GlcCer on cutaneous inflammation was evaluated by assessing ear thickness, lymph node weight, histological findings, and mRNA expression of pro-inflammatory cytokines such as IL-1β and IL-6. Additionally, parameters of the itch-associated response, including scratching behavior, water content of the skin, and aquaporin-3 levels in the lesional ear, were measured. Oral GlcCer administration significantly suppressed mRNA expression of the pro-inflammatory cytokines IL-1β and IL-6. GlcCer also suppressed ear swelling, lymph node weight gains, and infiltration of leukocytes and mast cells in ICD mice. In oxazolone-induced ICD mice, GlcCer significantly inhibited irritant-related scratching behavior and dehydration of the stratum corneum, and decreased aquaporin-3 expression. Our results indicate that GlcCer suppressed inflammation not only by inhibiting cytokine production but also by repairing the skin barrier function, suggesting a potential beneficial role for GlcCer in the improvement of chronic ICD. Copyright © 2012 Japanese Society for Investigative Dermatology. Published by Elsevier Ireland Ltd. All rights reserved.

  12. A double-blind, randomized, bilateral comparison of skin irritancy following application of the combination acne products clindamycin/tretinoin and benzoyl peroxide/adapalene.

    PubMed

    Goreshi, Renato; Samrao, Aman; Ehst, Benjamin D

    2012-12-01

    The use of topical medications for acne vulgaris is often limited by their irritant properties. Newer combination preparations are available and offer convenience, but irritant potential may still be a hindrance, perhaps more so with the combination of 2 agents. Few studies have compared these formulations directly for tolerability. We sought to compare the tolerability of 2 combination topical acne products, clindamycin 1.2%-tretinoin 0.025% (CLIN/RA) gel and benzoyl peroxide 2.5%-adapalene 0.1% (BPO/ADA) gel. CLIN/RA and BPO/ADA were applied daily to opposite sides of a subject's face for 21 days in a double-blinded fashion. Investigators' Global Assessments and study subject self-assessments of burning/stinging, itching, erythema, and dryness/scaling were collected. Transepidermal water loss (TEWL) was also measured as an objective measure of skin irritation. A mixed model analysis and repeated-measures analysis of variance were used to compare outcomes for both acne formulations. CLIN/RA produced significantly less burning/stinging than BPO/ADA (P<.001) as well as significantly less pruritus than BPO/ ADA (P<.001). BPO/ADA caused significantly more TEWL than CLIN/RA (P=.005). There was no significant difference in the amount of erythema or the amount of dryness/scaling caused by either formulation. CLIN/RA produced significantly less skin irritancy and TEWL than BPO/ADA.

  13. Skin prick tests and allergy diagnosis.

    PubMed

    Antunes, João; Borrego, Luís; Romeira, Ana; Pinto, Paula

    2009-01-01

    Skin testing remains an essential diagnostic tool in modern allergy practice. A significant variability has been reported regarding technical procedures, interpretation of results and documentation. This review has the aim of consolidating methodological recommendations through a critical analysis on past and recent data. This will allow a better understanding on skin prick test (SPT) history; technique; (contra-) indications; interpretation of results; diagnostic pitfalls; adverse reactions; and variability factors.

  14. In vivo immunomodulatory, cumulative skin irritation, sensitization and effect of d-limonene on permeation of 6-mercaptopurine through transdermal drug delivery.

    PubMed

    Chandrashekar, N S; Hiremath, Shobha Rani Rajeev

    2008-04-01

    Using skin as a port for systemic drug administration, transdermal drug delivery has expanded greatly over the last two decades. Our aim was to formulate the single layer drug-in-adhesive transdermal patch for 6-mercaptopurine (6-MP). In vitro permeation study was carried out using modified Franz diffusion cell with and without of different concentration of d-limonene in human cadaver skin. In vivo immunomodulatory was carried out in mice, cumulative skin irritation, sensitization and patch adherence study was done in both mice and human subjects. 6-MP flux increased from 43+/-12.2 microg/cm2h (control) to 162.8+/-32.2 microg/cm2h (6% w/v d-limonene) data was significant (p<0.05), with decrease in the lag time to 35+/-9.3 min compared to control of 90 +/-15.3 min. In vivo immunomodulatory effect was shown in the Balb/c mice with 100 mumol/kg/body wt of animal for 5d (one dose/d) of d-limonene. WBC count of 13469 cells/mm peak was observed on 12th day, bone marrow cells of 26.3 x 10(6) cells/femur and alpha-esterase positive cells of 1259+/-328.4 cells/4000 bone marrow cells. Cumulative skin irritation, sensitisation and patch adherence in animals and human subjects showed no skin irritation and sensitization. Patch adhesion was greater than 90.0% respectively in both human subjects and mice. The percentage of human subjects with adhesive residue was significantly less with scores of zero. d-Limonene proved as good chemical enhancer by increasing in the skin permeability with shortened the lag time. It proved that therapeutic amount of 6-MP can be delivered through transdermal drug delivery.

  15. In vitro eye irritation testing using the open source reconstructed hemicornea - a ring trial.

    PubMed

    Mewes, Karsten R; Engelke, Maria; Zorn-Kruppa, Michaela; Bartok, Melinda; Tandon, Rashmi; Brandner, Johanna M; Petersohn, Dirk

    2017-01-01

    The aim of the present ring trial was to test whether two new methodological approaches for the in vitro classification of eye irritating chemicals can be reliably transferred from the developers' laboratories to other sites. Both test methods are based on the well-established open source reconstructed 3D hemicornea models. In the first approach, the initial depth of injury after chemical treatment in the hemicornea model is derived from the quantitative analysis of histological sections. In the second approach, tissue viability, as a measure for corneal damage after chemical treatment, is analyzed separately for epithelium and stroma of the hemicornea model. The three independent laboratories that participated in the ring trial produced their own hemicornea models according to the test producer's instructions, thus supporting the open source concept. A total of 9 chemicals with different physicochemical and eye-irritating properties were tested to assess the between-laboratory reproducibility (BLR), the predictive performance, as well as possible limitations of the test systems. The BLR was 62.5% for the first and 100% for the second method. Both methods enabled to discriminate Cat. 1 chemicals from all non-Cat. 1 substances, which qualifies them to be used in a top-down approach. However, the selectivity between No Cat. and Cat. 2 chemicals still needs optimization.

  16. Skin Prick Test in Patients with Chronic Allergic Skin Disorders

    PubMed Central

    Bains, Pooja; Dogra, Alka

    2015-01-01

    Background: Chronic allergic skin disorders are the inflammatory and proliferative conditions in which both genetic and environmental factors play important roles. Chronic idiopathic urticaria (CIU) and atopic dermatitis (AD) are among the most common chronic allergic skin disorders. These can be provoked by various food and aeroallergens. Skin prick tests (SPTs) represent the cheapest and most effective method to diagnose type I hypersensitivity. Positive skin tests with a history suggestive of clinical sensitivity strongly incriminate the allergen as a contributor to the disease process. Aims and Objectives: To determine the incidence of positive SPT in patients with chronic allergic skin disorders and to identify the various allergens implicated in positive SPT. Methods: Fifty patients of chronic allergic disorders were recruited in this study. They were evaluated by SPT with both food and aeroallergens. Results: In our study, SPT positivity in patients of CIU was 63.41% and in AD was 77.78%. Out of the 41 patients of CIU, the most common allergen groups showing SPT positivity were dust and pollen, each comprising 26.83% patients. SPT reaction was positive with food items (21.6%), insects (17.07%), fungus (12.20%), and Dermatophagoides farinae, that is, house dust mite (HDM) (7.32%). The allergen which showed maximum positivity was grain dust wheat (19.51%). Among nine patients of AD, maximum SPT positivity was seen with Dermatophagoides farinae, pollen Amaranthus spinosus, grain dust wheat, and cotton mill dust; each comprising 22.22% of patients. Conclusion: Our study showed that a significant number of patients of CIU and AD showed sensitivity to dust, pollen, insects, Dermatophagoides farinae, and fungi on SPT. Thus, it is an important tool in the diagnosis of CIU and AD. PMID:25814704

  17. Eye Irritation Test (EIT) for Hazard Identification of Eye Irritating Chemicals using Reconstructed Human Cornea-like Epithelial (RhCE) Tissue Model.

    PubMed

    Kaluzhny, Yulia; Kandárová, Helena; d'Argembeau-Thornton, Laurence; Kearney, Paul; Klausner, Mitchell

    2015-08-23

    To comply with the Seventh Amendment to the EU Cosmetics Directive and EU REACH legislation, validated non-animal alternative methods for reliable and accurate assessment of ocular toxicity in man are needed. To address this need, we have developed an eye irritation test (EIT) which utilizes a three dimensional reconstructed human cornea-like epithelial (RhCE) tissue model that is based on normal human cells. The EIT is able to separate ocular irritants and corrosives (GHS Categories 1 and 2 combined) and those that do not require labeling (GHS No Category). The test utilizes two separate protocols, one designed for liquid chemicals and a second, similar protocol for solid test articles. The EIT prediction model uses a single exposure period (30 min for liquids, 6 hr for solids) and a single tissue viability cut-off (60.0% as determined by the MTT assay). Based on the results for 83 chemicals (44 liquids and 39 solids) EIT achieved 95.5/68.2/ and 81.8% sensitivity/specificity and accuracy (SS&A) for liquids, 100.0/68.4/ and 84.6% SS&A for solids, and 97.6/68.3/ and 83.1% for overall SS&A. The EIT will contribute significantly to classifying the ocular irritation potential of a wide range of liquid and solid chemicals without the use of animals to meet regulatory testing requirements. The EpiOcular EIT method was implemented in 2015 into the OECD Test Guidelines as TG 492.

  18. Eye Irritation Test (EIT) for Hazard Identification of Eye Irritating Chemicals using Reconstructed Human Cornea-like Epithelial (RhCE) Tissue Model

    PubMed Central

    Kaluzhny, Yulia; Kandárová, Helena; d’Argembeau-Thornton, Laurence; Kearney, Paul; Klausner, Mitchell

    2015-01-01

    To comply with the Seventh Amendment to the EU Cosmetics Directive and EU REACH legislation, validated non-animal alternative methods for reliable and accurate assessment of ocular toxicity in man are needed. To address this need, we have developed an eye irritation test (EIT) which utilizes a three dimensional reconstructed human cornea-like epithelial (RhCE) tissue model that is based on normal human cells. The EIT is able to separate ocular irritants and corrosives (GHS Categories 1 and 2 combined) and those that do not require labeling (GHS No Category). The test utilizes two separate protocols, one designed for liquid chemicals and a second, similar protocol for solid test articles. The EIT prediction model uses a single exposure period (30 min for liquids, 6 hr for solids) and a single tissue viability cut-off (60.0% as determined by the MTT assay). Based on the results for 83 chemicals (44 liquids and 39 solids) EIT achieved 95.5/68.2/ and 81.8% sensitivity/specificity and accuracy (SS&A) for liquids, 100.0/68.4/ and 84.6% SS&A for solids, and 97.6/68.3/ and 83.1% for overall SS&A. The EIT will contribute significantly to classifying the ocular irritation potential of a wide range of liquid and solid chemicals without the use of animals to meet regulatory testing requirements. The EpiOcular EIT method was implemented in 2015 into the OECD Test Guidelines as TG 492. PMID:26325674

  19. The EpiOcular Eye Irritation Test (EIT) for hazard identification and labelling of eye irritating chemicals: protocol optimisation for solid materials and the results after extended shipment.

    PubMed

    Kaluzhny, Yulia; Kandárová, Helena; Handa, Yuki; DeLuca, Jane; Truong, Thoa; Hunter, Amy; Kearney, Paul; d'Argembeau-Thornton, Laurence; Klausner, Mitchell

    2015-05-01

    The 7th Amendment to the EU Cosmetics Directive and the EU REACH Regulation have reinforced the need for in vitro ocular test methods. Validated in vitro ocular toxicity tests that can predict the human response to chemicals, cosmetics and other consumer products are required for the safety assessment of materials that intentionally, or inadvertently, come into contact with the eye. The EpiOcular Eye Irritation Test (EIT), which uses the normal human cell-based EpiOcular™ tissue model, was developed to address this need. The EpiOcular-EIT is able to discriminate, with high sensitivity and accuracy, between ocular irritant/corrosive materials and those that require no labelling. Although the original EpiOcular-EIT protocol was successfully pre-validated in an international, multicentre study sponsored by COLIPA (the predecessor to Cosmetics Europe), data from two larger studies (the EURL ECVAM-COLIPA validation study and an independent in-house validation at BASF SE) resulted in a sensitivity for the protocol for solids that was below the acceptance criteria set by the Validation Management Group (VMG) for eye irritation, and indicated the need for improvement of the assay's sensitivity for solids. By increasing the exposure time for solid materials from 90 minutes to 6 hours, the optimised EpiOcular-EIT protocol achieved 100% sensitivity, 68.4% specificity and 84.6% accuracy, thereby meeting all the acceptance criteria set by the VMG. In addition, to satisfy the needs of Japan and the Pacific region, the EpiOcular-EIT method was evaluated for its performance after extended shipment and storage of the tissues (4-5 days), and it was confirmed that the assay performs with similar levels of sensitivity, specificity and reproducibility in these circumstances. 2015 FRAME.

  20. CON4EI: Development of testing strategies for hazard identification and labelling for serious eye damage and eye irritation of chemicals.

    PubMed

    Adriaens, E; Verstraelen, S; Alépée, N; Kandarova, H; Drzewiecka, A; Gruszka, K; Guest, R; Willoughby, J A; Van Rompay, A R

    2018-06-01

    Assessment of acute eye irritation potential is part of the international regulatory requirements for safety testing of chemicals. In the last decades, many efforts have been made in the search for alternative methods to replace the regulatory in vivo Draize rabbit eye test (OECD TG 405). Success in terms of complete replacement of the regulatory in vivo Draize rabbit eye test has not yet been achieved. The main objective of the CEFIC-LRI-AIMT6-VITO CON4EI (CONsortium for in vitro Eye Irritation testing strategy) project was to develop tiered testing strategies for serious eye damage and eye irritation assessment that can lead to complete replacement of OECD TG 405. A set of 80 reference chemicals (e.g. balanced by important driver of classification and physical state), was tested with seven test methods. Based on the results of this project, three different strategies were suggested. We have provided a standalone (EpiOcular ET-50), a two-tiered and three-tiered strategy, that can be used to distinguish between Cat 1 and Cat 2 chemicals and chemicals that do not require classification (No Cat). The two-tiered and three-tiered strategies use an RhCE test method (EpiOcular EIT or SkinEthic™ EIT) at the bottom (identification No Cat) in combination with the BCOP LLBO (two-tiered strategy) or BCOP OP-KIT and SMI (three-tiered strategy) at the top (identification Cat 1). For our proposed strategies, 71.1% - 82.9% Cat 1, 64.2% - 68.5% Cat 2 and ≥80% No Cat chemicals were correctly identified. Also, similar results were obtained for the Top-Down and Bottom-Up approach. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Significance of hair-dye base-induced sensory irritation.

    PubMed

    Fujita, F; Azuma, T; Tajiri, M; Okamoto, H; Sano, M; Tominaga, M

    2010-06-01

    Oxidation hair-dyes, which are the principal hair-dyes, sometimes induce painful sensory irritation of the scalp caused by the combination of highly reactive substances, such as hydrogen peroxide and alkali agents. Although many cases of severe facial and scalp dermatitis have been reported following the use of hair-dyes, sensory irritation caused by contact of the hair-dye with the skin has not been reported clearly. In this study, we used a self-assessment questionnaire to measure the sensory irritation in various regions of the body caused by two model hair-dye bases that contained different amounts of alkali agents without dyes. Moreover, the occipital region was found as an alternative region of the scalp to test for sensory irritation of the hair-dye bases. We used this region to evaluate the relationship of sensitivity with skin properties, such as trans-epidermal water loss (TEWL), stratum corneum water content, sebum amount, surface temperature, current perception threshold (CPT), catalase activities in tape-stripped skin and sensory irritation score with the model hair-dye bases. The hair-dye sensitive group showed higher TEWL, a lower sebum amount, a lower surface temperature and higher catalase activity than the insensitive group, and was similar to that of damaged skin. These results suggest that sensory irritation caused by hair-dye could occur easily on the damaged dry scalp, as that caused by skin cosmetics reported previously.

  2. Mammalian Toxicity of Munition Compounds. Phase 1. Acute Oral Toxicity Primary Skin and Eye Irritation, Dermal Sensitization, and Disposition and Metabolism

    DTIC Science & Technology

    1975-07-22

    Mononitroglycerins Nitrocellulose White Phosphor 20. ABSTRACT (C^nllnu eery and Identify by block number) 0D | jSJ’TJ M73 EDITION OF I NOV 6» IS...White Phosphorus 2. Synthesis of DNGs and MNGs 3. Analysis of Chemicals . C. Acute LD D. Primary Skin and Eye Irritation E. Dermal...by the Radford Army Ammunition Plant (Radford, Virginia). 2. Synthesis of DNGs and MNGs a. 1,2-DNG: to that of Dunstan et al.— The sample was

  3. Suitability of macrophage inflammatory protein-1beta production by THP-1 cells in differentiating skin sensitizers from irritant chemicals.

    PubMed

    Lim, Yeon-Mi; Moon, Seong-Joon; An, Su-Sun; Lee, Soo-Jin; Kim, Seo-Young; Chang, Ih-Seop; Park, Kui-Lea; Kim, Hyoung-Ah; Heo, Yong

    2008-04-01

    Worldwide restrictions in animal use for research have driven efforts to develop alternative methods. The study aimed to test the efficacy of the macrophage inflammatory protein-1beta (MIP-1beta) assay for testing chemicals' skin-sensitizing capacity. The assay was performed using 9 chemicals judged to be sensitizing and 7 non-sensitizing by the standard in vivo assays. THP-1 cells were cultured in the presence or absence of 4 doses, 0.01x, 0.1x, 0.5x, or 1x IC(50) (50% inhibitory concentration for THP-1 cell proliferation) of these chemicals for 24 hr, and the MIP-1beta level in the supernatants was determined. Skin sensitization by the test chemicals was determined by MIP-1beta production rates. The MIP-1beta production rate was expressed as the relative increase in MIP-1beta production in response to chemical treatment compared with vehicle treatment. When the threshold MIP-1beta production rate used was 100% or 105% of dimethyl sulfoxide, all the sensitizing chemicals tested (dinitrochlorobenzene, hexyl cinnamic aldehyde, eugenol, hydroquinone, dinitrofluorobenzene, benzocaine, nickel, chromium, and 5-chloro-2-methyl-4-isothiazolin-3-one) were positive, and all the non-sensitizing chemicals (methyl salicylate, benzalkonium chloride, lactic acid, isopropanol, and salicylic acid), with the exception of sodium lauryl sulfate, were negative for MIP-1beta production. These results indicate that MIP-1beta could be a biomarker for classification of chemicals as sensitizers or non-sensitizers.

  4. Evaluation of sex-related changes in skin topography and structure using innovative skin testing equipment.

    PubMed

    Dąbrowska, M; Mielcarek, A; Nowak, I

    2018-04-29

    Evaluation of skin condition on the basis of parametrization and objective measurements of the parameters has become obligatory. The aim of this study was to assess sex-related changes in skin topography and structure using the skin testing equipment. The study was carried out on the group of 40 volunteers (20 females and 20 males) of the mean age 24 ± 3 years. The skin parameters were measured using 3 devices: Visioscan ®  VC 98 (skin topography), Visioline ® VL 650 (skin macro relief) and Ultrascan UC22 (ultrasound imaging of the skin). All measurements were performed on the inner part of the left forearm. The skin parameters measured revealed significant differences in skin surface and structure between females and males. The skin of all women subjects was more homogenous in its structure with the presence of more abundant superficial skin lines and wrinkles in comparison to male skin. The higher number of skin furrows in the skin of women is in agreement with literature reports claiming that men's skin has lower number of wrinkles which are deeper and more pronounced. Ultrasound imaging of the skin indicated greater thickness and lower density of the dermis of men subjects compared to those of females. Non-invasive methods of skin testing using new and advanced equipment have provided a possibility of objective parametrization and evaluation of sex-related changes in skin topography and structure. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  5. Tretinoin cyclodextrin complex (RA/CyD) causes less irritation with an equal antiwrinkle effect compared with conventional tretinoin: clinical and histologic studies of photoaged skin.

    PubMed

    Miura, Tomoe; Takada, Akiyoshi; Ooe, Masahiko

    2012-08-01

    Topical tretinoin [all-trans-retinoic acid (RA)] currently is widely used to treat photoaged skin. However, undesirable side effects such as erythema, irritation, and scaling are unavoidable and limit the use of tretinoin. To address these issues, the authors developed the tretinoin cyclodextrin complex (RA/CyD), which is tretinoin encapsulated by cyclodextrin. Cyclodextrins are cyclic oligosaccharides commonly used in food additives and fabric fresheners. This study aimed to evaluate the antiwrinkle effect of RA/CyD and alleviation of the side effects compared with RA treatment alone. In this study, 12 photoaged patients completed an 8 week study using RA and RA/CyD in a double-blind manner. Before and after the treatment, the patients' evaluations, wrinkle scores, skin elasticity, and wrinkle area measurement using skin replica were evaluated. Three men were recruited for histologic analysis. The patients reported that undesirable irritant reactions were more moderate with RA/CyD than with RA. In the assessment of wrinkle scores, skin elasticity, and wrinkle area measurement, RA/CyD demonstrated an antiwrinkle effect statistically equal to that of RA. In histology, both RA/CyD and RA demonstrated epidermal hyperplasia. In immunohistochemistry, inflammation induced by RA/CyD was more moderate than that induced by RA. The findings show that RA and RA/CyD result in the equivalent clinical improvement for patients with photoaging. The use of RA/CyD overcomes the drawbacks of RA while possessing equal effect. It is expected that CyD will broaden tretinoin treatment. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors at www.springer.com/00266.

  6. Rapid analysis of the skin irritant p-phenylenediamine (PPD) in henna products using atmospheric solids analysis probe mass spectrometry.

    PubMed

    Chen, Weiyang; Nkosi, Thobile A N; Combrinck, Sandra; Viljoen, Alvaro M; Cartwright-Jones, Catherine

    2016-09-05

    Henna (Lawsonia inermis) is applied to stain keratin, present in hair, skin and fingernails, a red-orange or rust colour. Producers of temporary tattoos mix the aromatic amine compound, para-phenylenediamine (PPD) into natural henna to create 'black henna' that rapidly stains the skin black. However, PPD may cause severe delayed hypersensitivity reactions following skin contact. This study proposes a rapid direct-analysis method to detect and identify PPD using an atmospheric solids analysis probe (ASAP) coupled to a Q-ToF mass spectrometer (MS). Since laborious, multistep methods of analysis to determine PPD are undesirable, due to the instability of the compound in solution, a screening method involving no sample preparation steps was developed. Experiments were carried out to optimise the corona current, sample cone voltage, source temperature, and desolvation gas temperature to determine ideal ASAP-Q-ToF-MS analysing conditions. Eleven of the 109 henna samples, originating from various countries, tested positive for PPD when henna products were screened using ASAP-MS, without any form of sample preparation other than grinding. Ultra-performance liquid chromatography electrospray ionisation-mass spectrometry (UPLC-Q-ToF-MS) was subsequently used to confirm the results from ASAP and to determine the concentrations of PPD in henna products. The allergen was detected in the same eleven samples, with concentrations ranging from 0.05-4.21% (w/w). It can be concluded that the sensitivity of the ASAP-MS technique is sufficient (limit of detection=0.025% w/w) to allow screening of henna samples for the presence of PPD. This relatively new technique can be applied to commercial products without extraction, sample treatment or chromatographic separation. Copyright © 2016 Elsevier B.V. All rights reserved.

  7. Are Cosmetics Used in Developing Countries Safe? Use and Dermal Irritation of Body Care Products in Jimma Town, Southwestern Ethiopia

    PubMed Central

    Amasa, Wayessa; Santiago, Dante; Mekonen, Seblework; Ambelu, Argaw

    2012-01-01

    Background. Rabbit skin model was used to test skin irritation of the most commonly used cosmetic products in Jimma town, southwestern Ethiopia. The most commonly used cosmetics were Dove, Glysolid, College, Top Society, Fair and Lovely, Nivea, Lux, Magic fruit world, Solea, Body talk, Kris, Holly, Victoria, and Sweet Heart. Methods. Intact and abraded rabbit skins were tested for erythema and edema under shade and under sun exposure. Draize Primary Irritation Index (PII) was used to calculate skin irritation of each cosmetic. Cosmetic ingredients were analyzed from the labels. Results and Discussion. Only Dove cream caused no skin irritation except for an abraded skin under sun exposure for five consecutive days. It has been identified that application of cosmetics on abraded skin under sunny condition worsens the irritation. Cosmetic labels revealed that most ingredients used in all products were those restricted chemicals due to their adverse health effects. Conclusion. This study has concluded that use of cosmetics under sunshine and also on abraded skin increases skin irritation. Hence, those users who have abraded skin are advised not to apply those cosmetics on continuous basis specifically under sun exposure. PMID:23209460

  8. Mechanistic Analysis of Human Skin Distribution and Follicular Targeting of Adapalene-Loaded Biodegradable Nanospheres With an Insight Into Hydrogel Matrix Influence, In Vitro Skin Irritation, and In Vivo Tolerability.

    PubMed

    Sallam, Marwa Ahmed; Marín Boscá, María Teresa

    2017-10-01

    This work aimed at the development of a biocompatible, non-oily nanomedicine for follicular delivery of adapalene (AD) ameliorating its irritation potential for convenient localized topical treatment of acne vulgaris. AD was efficiently incorporated into poly-ε-caprolactone nanospheres (NS) with an encapsulation efficiency of 84.73% ± 1.52%, a particle size of 107.5 ± 8.19 nm, and zeta potential of -13.1 mV demonstrating a sustained-release behavior. The AD-NS were embedded in either hydroxypropyl methylcellulose (HPMC) or hyaluronate (HA) gel. The ex vivo human skin dermatokinetics of AD from each system was studied. The nanoparticles dispersion showed significantly higher AD retention in the epidermis and dermis than AD suspension. NS-HPMC decreased whereas NS-HA increased AD retained in all the skin layers. The fate of the NS and the role of the hydrogel in modulating skin distribution was evaluated by confocal laser scanning microscopy (CLSM) imaging of fluorescently labeled NS. CLSM illustrated follicular localization of the florescent NS. HPMC gel restricted the presence of NS to the stratum corneum and epidermis. HA gel enhanced the penetration of NS to all the skin layers. In vitro skin irritation using human dermal fibroblasts and in vivo animal tolerability studies were performed. Accordingly, HA gel-dispersed AD-NS presented a nonirritant compromised cosmeceutical formulation suitable for oily acneic skin. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  9. The skin prick test – European standards

    PubMed Central

    2013-01-01

    Skin prick testing is an essential test procedure to confirm sensitization in IgE-mediated allergic disease in subjects with rhinoconjunctivitis, asthma, urticaria, anapylaxis, atopic eczema and food and drug allergy. This manuscript reviews the available evidence including Medline and Embase searches, abstracts of international allergy meetings and position papers from the world allergy literature. The recommended method of prick testing includes the appropriate use of specific allergen extracts, positive and negative controls, interpretation of the tests after 15 – 20 minutes of application, with a positive result defined as a wheal ≥3 mm diameter. A standard prick test panel for Europe for inhalants is proposed and includes hazel (Corylus avellana), alder (Alnus incana), birch (Betula alba), plane (Platanus vulgaris), cypress (Cupressus sempervirens), grass mix (Poa pratensis, Dactilis glomerata, Lolium perenne, Phleum pratense, Festuca pratensis, Helictotrichon pretense), Olive (Olea europaea), mugwort (Artemisia vulgaris), ragweed (Ambrosia artemisiifolia), Alternaria alternata (tenuis), Cladosporium herbarum, Aspergillus fumigatus, Parietaria, cat, dog, Dermatophagoides pteronyssinus, Dermatophagoides farinae, and cockroach (Blatella germanica). Standardization of the skin test procedures and standard panels for different geographic locations are encouraged worldwide to permit better comparisons for diagnostic, clinical and research purposes. PMID:23369181

  10. Assessment of ocular discomfort caused by 5 shampoos using the Slug Mucosal Irritation test.

    PubMed

    Petit, Jean-Yanique; Doré, Vanessa; Marignac, Geneviève; Perrot, Sébastien

    2017-04-01

    Assessment of ocular discomfort caused by veterinary care products is less legitimately regulated than that caused by human care products. The Slug Mucosal Irritation (SMI) assay was adapted to evaluate canine hygiene shampoos to predict ocular discomfort. Experiments were performed using four commercial canine shampoos, a baby care product, and two controls (ArtTear® and BAC1%). Groups of 3 slugs were tested with 5% dilution of the 7 test substances. The negative control (ArtTear®) was the best tolerated. The baby care product Mixa bébé as well as Douxo Entretien Démêlant and Phlox Shampooing Entretien were classified to cause mild ocular discomfort. Together with the positive control (BAC 1%), Shampooing Physiologique Virbac and Physiovet Shampooing were considered to cause severe ocular discomfort. Different intensities of ocular discomfort were measured for veterinary care products. The SMI model was considered as a reproducible and adaptable evaluation method for screening veterinary care products causing ocular discomfort. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Analysis of Draize Eye Irritation Testing and its Prediction by Mining Publicly Available 2008–2014 REACH Data

    PubMed Central

    Luechtefeld, Thomas; Maertens, Alexandra; Russo, Daniel P.; Rovida, Costanza; Zhu, Hao; Hartung, Thomas

    2017-01-01

    Summary Public data from ECHA online dossiers on 9,801 substances encompassing 326,749 experimental key studies and additional information on classification and labeling were made computable. Eye irritation hazard, for which the rabbit Draize eye test still represents the reference method, was analyzed. Dossiers contained 9,782 Draize eye studies on 3,420 unique substances, indicating frequent retesting of substances. This allowed assessment of the test’s reproducibility based on all substances tested more than once. There was a 10% chance of a non-irritant evaluation after a prior severe-irritant result according to UN GHS classification criteria. The most reproducible outcomes were the results negative (94% reproducible) and severe eye irritant (73% reproducible). To evaluate whether other GHS categorizations predict eye irritation, we built a dataset of 5,629 substances (1,931 “irritant” and 3,698 “non-irritant”). The two best decision trees with up to three other GHS classifications resulted in balanced accuracies of 68% and 73%, i.e., in the rank order of the Draize rabbit eye test itself, but both use inhalation toxicity data (“May cause respiratory irritation”), which is not typically available. Next, a dataset of 929 substances with at least one Draize study was mapped to PubChem to compute chemical similarity using 2D conformational fingerprints and Tanimoto similarity. Using a minimum similarity of 0.7 and simple classification by the closest chemical neighbor resulted in balanced accuracy from 73% over 737 substances to 100% at a threshold of 0.975 over 41 substances. This represents a strong support of read-across and (Q)SAR approaches in this area. PMID:26863293

  12. Association between Symptoms of Irritable Bowel Syndrome and Methane and Hydrogen on Lactulose Breath Test

    PubMed Central

    Lee, Kang Nyeong; Koh, Dong Hee; Sohn, Won; Lee, Sang Pyo; Jun, Dae Won; Lee, Hang Lak; Yoon, Byung Chul; Choi, Ho Soon; Hahm, Joon Soo

    2013-01-01

    Whether hydrogen and methane gas produced during lactulose breath test (LBT) are associated with symptoms of irritable bowel syndrome (IBS) is not determined. We aimed to investigate whether hydrogen and methane on LBT are associated with IBS symptoms. Sixty-eight IBS patients meeting the Rome III criteria for IBS, and 55 healthy controls, underwent LBT. The IBS subjects recorded their customary gastrointestinal symptoms on a questionnaire using visual analogue scales. LBT positivity was defined to be above 20 ppm rise of hydrogen or 10 ppm rise of methane within 90 min. Gas amounts produced during LBT were determined by calculating area under the curve of hydrogen and methane excretion. Symptom severity scores were not different between the LBT (+) IBS and LBT (-) IBS subjects and also between methane producers and non-methane producers. Gas amounts produced during LBT were not associated with IBS symptoms, except a weak correlation between total gas amounts and a few IBS symptoms such as bloating (r = 0.324, P = 0.039), flatulence (r = 0.314, P = 0.046) and abdominal pain (r = 0.364, P = 0.018) only in LBT (+) IBS. In conclusion, hydrogen and methane gas on LBT are not useful for predicting the customary symptoms and subtypes of IBS. PMID:23772156

  13. Skin Conditions

    MedlinePlus

    Your skin is your body's largest organ. It covers and protects your body. Your skin Holds body fluids in, preventing dehydration Keeps harmful ... it Anything that irritates, clogs, or inflames your skin can cause symptoms such as redness, swelling, burning, ...

  14. Reactions to prick and intradermal skin tests.

    PubMed

    Bagg, Andrew; Chacko, Thomas; Lockey, Richard

    2009-05-01

    Allergy skin testing is a common procedure for the diagnosis of atopic diseases with a small risk of systemic reactions. To determine the 12-month incidence of systemic reactions (SRs) to skin prick testing (SPT) and intradermal skin testing (ST) and the symptoms and response to immediate treatment with epinephrine intramuscularly. A prospective study was conducted to evaluate SRs from ST in 1,456 patients. A standard form was used to record symptoms, signs, and treatment. The SRs are defined as any sign or symptom other than a local reaction thought to be secondary to ST. No vasovagal reactions were included. Nurses, as instructed by attending physicians, administered epinephrine (0.2 mL of a 1:1,000 dilution) intramuscularly in the deltoid as soon as any remote signs or symptoms occurred. Fifty-two patients (3.6%) had SRs (6 SPT and 46 intradermal): 43 (83%) were female, and 17 (33%) had asthma. Systemic symptoms included (SPT/intradermal) pruritic eyes, nose, or pharynx (0%/46%); worsening cough (50%/26%); sensation of difficulty swallowing (0%/20%); worsening nasal congestion (17%/15%); rhinorrhea (17%/13%); chest tightness or shortness of breath (33%/11%); generalized pruritus (17%/11%); sneezing (33%/9%); wheeze (0%/4%); and urticaria (17%/2%). No severe asthma, shock, hypotension, unconsciousness, or biphasic reactions occurred. All 52 patients received epinephrine intramuscularly, 48 (92%) oral prednisone, 9 (17%) oral prednisone to take 6 to 8 hours after a reaction, 50 (96%) oral antihistamine, and 6 (12%) nebulized beta-agonist. Of patients who underwent ST, SRs occurred in 3.6% (0.4% for SPT and 3.2% for intradermal ST), all of whom readily responded to epinephrine intramuscularly in the deltoid. This immediate administration of epinephrine seems to prevent more serious and biphasic reactions.

  15. Penicillin skin testing in cardiac surgery.

    PubMed

    Cook, David J; Barbara, David W; Singh, Karen E; Dearani, Joseph A

    2014-06-01

    Penicillin is the most commonly reported allergy in cardiac surgical patients and a history of penicillin allergy frequently results in the use of vancomycin for antibiotic prophylaxis. However, clinical history is unreliable and true allergy is rare. Penicillin allergy testing has the potential to reduce vancomycin use and indirectly the potential for selection of vancomycin-resistant organisms, a national priority. After the publication of the 2007 Society of Thoracic Surgeons practice guideline report, we initiated a penicillin allergy testing service for cardiac surgical patients in 2009. We sought to determine the true incidence of penicillin allergy in the tested population, whether testing availability reduced vancomycin use in those tested, and if vancomycin use was reduced in the entire cardiac surgical population as a whole. A total of 276 patients were skin tested for allergy to penicillin or cephalosporin. Testing recommended no penicillin use in 13.8% of those tested giving a true penicillin allergy incidence of 0.9%. Only 24 of the 276 patients tested (9%) received vancomycin. However, given the small percentage of the total population that underwent allergy testing, the overall use of vancomycin in the cardiac surgery practice was not reduced in the posttesting period. The true rate of contraindication to penicillin in a cardiac surgical population is very low. Penicillin allergy testing can reduce vancomycin use in the tested population, but better means of conducting the testing and making the results available are necessary to reduce unnecessary vancomycin use in a broader cardiac surgical population. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  16. Winter season, frequent hand washing, and irritant patch test reactions to detergents are associated with hand dermatitis in healthcare workers

    PubMed Central

    Callahan, Adrienne; Baron, Elma; Fekedulegn, Desta; Kashon, Michael; Yucesoy, Berran; Johnson, Victor J.; Santo Domingo, Diana; Kirkland, Brent; Luster, Michael I.; Nedorost, Susan

    2013-01-01

    Background Irritant hand dermatitis (IHD) is common in healthcare workers. Objective We studied endogenous irritant contact dermatitis threshold by patch testing, and exogenous factors such as season and hand washing for their association with IHD in healthcare workers. Methods Irritant patch testing with sodium lauryl sulfate (SLS), sodium hydroxide (NaOH) and benzalkonium chloride (BAK) at varying concentrations was measured in 113 healthcare workers. Examination for hand dermatitis occurred at one month intervals for a period of six months in the Midwestern US. Results Positive patch testing to low concentration SLS was associated with IHD (p=0.0310) after adjusting for age, gender, ethnicity, season, history of childhood flexural dermatitis, mean indoor relative humidity, glove and hand sanitizer usage). Subjects with a positive patch test to SLS were 78% more likely to have occurrence of IHD (IRR=1.78, 95% CI: 0.92, 3.45). Hand washing frequency (≥ 10 times a day; IRR=1.55, 95% CI: 1.01, 2.39) and cold season (IRR=2.76, 95% CI: 1.35, 5.65) were associated with IHD. No association was found between history of childhood flexural dermatitis and IHD in this population. Conclusions Both genetic and environmental factors are important in the etiology of IHD and should be considered in designing strategies to protect, educate and treat susceptible individuals. PMID:23857011

  17. Seeking Clearer Recommendations for Hand Hygiene in Communities Facing Ebola: A Randomized Trial Investigating the Impact of Six Handwashing Methods on Skin Irritation and Dermatitis.

    PubMed

    Wolfe, Marlene K; Wells, Emma; Mitro, Brittany; Desmarais, Anne Marie; Scheinman, Pamela; Lantagne, Daniele

    2016-01-01

    To prevent disease transmission, 0.05% chlorine solution is commonly recommended for handwashing in Ebola Treatment Units. In the 2014 West Africa outbreak this recommendation was widely extended to community settings, although many organizations recommend soap and hand sanitizer over chlorine. To evaluate skin irritation caused by frequent handwashing that may increase transmission risk in Ebola-affected communities, we conducted a randomized trial with 91 subjects who washed their hands 10 times a day for 28 days. Subjects used soap and water, sanitizer, or one of four chlorine solutions used by Ebola responders (calcium hypochlorite (HTH), sodium dichloroisocyanurate (NaDCC), and generated or pH-stabilized sodium hypochlorite (NaOCl)). Outcomes were self-reported hand feel, irritation as measured by the Hand Eczema Score Index (HECSI) (range 0-360), signs of transmission risk (e.g., cracking), and dermatitis diagnosis. All groups experienced statistically significant increases in HECSI score. Subjects using sanitizer had the smallest increases, followed by higher pH chlorine solutions (HTH and stabilized NaOCl), and soap and water. The greatest increases were among neutral pH chlorine solutions (NaDCC and generated NaOCl). Signs of irritation related to higher transmission risk were observed most frequently in subjects using soap and least frequently by those using sanitizer or HTH. Despite these irritation increases, all methods represented minor changes in HECSI score. Average HECSI score was only 9.10 at endline (range 1-33) and 4% (4/91) of subjects were diagnosed with dermatitis, one each in four groups. Each handwashing method has benefits and drawbacks: soap is widely available and inexpensive, but requires water and does not inactivate the virus; sanitizer is easy-to use and effective but expensive and unacceptable to many communities, and chlorine is easy-to-use but difficult to produce properly and distribute. Overall, we recommend Ebola responders and

  18. Quiz: Test Your Skin Cancer IQ

    MedlinePlus

    ... three main types of skin cancer: basal cell carcinoma, squamous cell carcinoma, and melanoma. They can develop from the uncontrolled growth of three different types of skin cells: basal cells, squamous cells, and melanocytes, respectively. A is the correct answer. ...

  19. The Ex vivo Eye Irritation Test (EVEIT) model as a mean of improving venom ophthalmia understanding.

    PubMed

    Delafontaine, Marie; Panfil, Claudia; Spöler, Felix; Kray, Stefan; Burgher, François; Mathieu, Laurence; Blomet, Joël; Schrage, Norbert F; Tambourgi, Denise V

    2018-06-08

    Snakes belonging to the genus Naja (Elapid family), also known as "spitting cobras", can spit venom towards the eyes of the predator as a defensive strategy, causing painful and potentially blinding ocular envenoming. Venom ophthalmia is characterized by pain, hyperemia, blepharitis, blepharospasm and corneal erosions. Elapid venom ophthalmia is not well documented and no specific treatment exists. Furthermore, accidental ejection of venom by non-spitting vipers, as Bothrops, also occurs. The Ex vivo Eye Irritation Test model (EVEIT) has enabled important progress in the knowledge of chemical ocular burns. Considering the lack of experimental animal model, we adapted the EVEIT to study venom ophthalmia mechanisms. Ex vivo rabbit corneas were exposed to venoms from spitting (Naja mossambica, Naja nigricollis) and non-spitting (Naja naja, Bothrops jararaca and Bothrops lanceolatus) snakes, and rinsed or not with water. The corneal thickness and the depth of damage were assessed using high-resolution optical coherence tomography (HR-OCT) imaging and histological analysis. All Naja venoms induced significant corneal edema, collagen structure disorganization and epithelial necrosis. Corneas envenomed by African N. mossambica and N. nigricollis venoms were completely opaque. Opacification was not observed in corneas treated with venoms from non-spitting snakes, such as the Asian cobra, N. naja, and the vipers, B. jararaca and B. lanceolatus. Moreover, Bothrops venoms were able to damage the epithelium and cause collagen structure disorganization, but not edema. Immediate water rinsing improved corneal status, though damage and edema could still be observed. In conclusion, the present study shows that the EVEIT model was successfully adapted to set a new experimental ex vivo animal model of ophthalmia, caused by snake venoms, which will enable to explore new therapies for venom ophthalmia. Copyright © 2018. Published by Elsevier Ltd.

  20. Clinical history as a predictor of penicillin skin test outcome.

    PubMed

    Wong, Benjamin B L; Keith, Paul K; Waserman, Susan

    2006-08-01

    Up to 10% of the population reports an "allergy" to penicillin, whereas approximately 1.1% has positive penicillin skin test results. Where penicillin skin tests are unavailable, some have advocated using history to decide whether to use a penicillin-related antibiotic. To determine if clinical history predicts penicillin skin test results. Retrospective medical record review of 94 consecutive patients who had previously taken penicillin referred for penicillin allergy. Case histories were taken, penicillin skin tests performed, and an oral challenge recommended if skin test results were negative. Of 91 cases studied, the average patient age was 27 years (range, 6 months to 82 years; 36% female). Fifty-two (57%) experienced hives as their main adverse reaction. Sixteen (18%) had at least 1 positive test result. Of this group, 9 had hives as their main symptom, whereas 1 had respiratory problems and 1 had angioedema. Most patients with positive skin test results had experienced their reaction at least 3 years ago. Regression analysis showed that age, sex, and clinical history, including type of reaction, time of reaction after penicillin ingestion, or time since the last reaction, were not associated with skin test positivity. Seventy-two (96%) of the 75 patients who had negative skin test results underwent oral challenge. Seventy had negative challenge results. The negative predictive value of a negative penicillin skin test result was 97%. Clinical history was not predictive of subsequent penicillin skin test results.

  1. Cumulative irritation potential of topical retinoid formulations.

    PubMed

    Leyden, James J; Grossman, Rachel; Nighland, Marge

    2008-08-01

    Localized irritation can limit treatment success with topical retinoids such as tretinoin and adapalene. The factors that influence irritant reactions have been shown to include individual skin sensitivity, the particular retinoid and concentration used, and the vehicle formulation. To compare the cutaneous tolerability of tretinoin 0.04% microsphere gel (TMG) with that of adapalene 0.3% gel and a standard tretinoin 0.025% cream. The results of 2 randomized, investigator-blinded studies of 2 to 3 weeks' duration, which utilized a split-face method to compare cumulative irritation scores induced by topical retinoids in subjects with healthy skin, were combined. Study 1 compared TMG 0.04% with adapalene 0.3% gel over 2 weeks, while study 2 compared TMG 0.04% with tretinoin 0.025% cream over 3 weeks. In study 1, TMG 0.04% was associated with significantly lower cumulative scores for erythema, dryness, and burning/stinging than adapalene 0.3% gel. However, in study 2, there were no significant differences in cumulative irritation scores between TMG 0.04% and tretinoin 0.025% cream. Measurements of erythema by a chromameter showed no significant differences between the test formulations in either study. Cutaneous tolerance of TMG 0.04% on the face was superior to that of adapalene 0.3% gel and similar to that of a standard tretinoin cream containing a lower concentration of the drug (0.025%).

  2. [Allergens used in skin tests in Mexico].

    PubMed

    Larenas Linnemann, Désirée; Arias Cruz, Alfredo; Guidos Fogelbach, Guillermo Arturo; Cid del Prado, Mari Lou

    2009-01-01

    Immunotherapy is the only recognized causal treatment for allergies. It is prepared on an individual basis, based on the patient's clinical history and the result of the skin prick test (SPT). An adequate composition of the allergens with which to test the patient is crucial for an optimal diagnosis. To know allergens used in tests in allergy practices in Mexico. A national survey among all members of the Colegio Mexicano de Inmunología Clínica y Alergia (CMICA) and of the Colegio Mexicano de Pediatras Especialistas en Inmunología Clínica y Alergia (COMPEDIA) was carried out. In a second phase respondents were asked to send in the composition of a routine SPT in their clinic. The results are presented descriptively and the frequency is calculated by which certain allergen is tested in the interviewed practices. A survey response rate of 61 (17%) was obtained and 54% showed their SPT content. Weeds' representation in the SPT seems adequate; Atriplex is tested in all allergy practices. Some trees that show cross-reactivity might be eliminated from the SPT, but 20% doesn't test for Cynodon nor Holcus, and 25% doesn't for important allergens as cat, dog and cockroach. House dust and tobacco are still tested with certain frequency. The selection of which allergens to test in a SPT is based on multiple data, that change continuously with new investigations and discoveries. Our specialty is the most indicated--and obligated--to adjust constantly to these changes to have the best diagnostic tool to detect specific allergies.

  3. Tuberculin skin testing: Spectrum of adverse reactions.

    PubMed

    Praveen, Ramar; Bahuguna, Amit; Dhadwal, Bhumesh Singh

    2015-01-01

    Tuberculin skin testing (TST) is one of the primary diagnostic modalities recommended by the World Health Organization (WHO) and the National Institute for Health and Care Excellence (NICE) study conducted in the United Kingdom (UK) for diagnosing tuberculosis (TB). Even after acceptance as a diagnostic modality and stern standardization, TST has its own flaws that include a spectrum of adverse reactions. We report a series of cases with a spectrum of adverse reactions occurring with a higher frequency than present in the available evidence. The study has some demerits such as being a retrospective one with interobserver variation and lack of histopathological confirmation. The observation is presented to accentuate the fact that adverse reactions are not a rarity and that further studies are required to establish the cause and exact incidence of the same.

  4. 16 CFR 1500.41 - Method of testing primary irritant substances.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... example: Skin reaction Exposure time (hours) Evaluation value Erythema and eschar formation: Intact skin... patches are removed and the resulting reactions are evaluated on the basis of the designated values in the following table: Skin reaction Value 1 Erythema and eschar formation: No erythema 0 Very slight erythema...

  5. Tuberculin skin testing: determinants and reaction.

    PubMed

    Lao, L Y; De Guia, T

    1999-09-01

    Mantoux purified protein derivative (PPD) skin testing was performed in schoolchildren who were grouped according to positive (Group I, n = 205) and negative (Group II, n = 79) exposure to recent acid-fast bacilli (AFB) smear-positive tuberculosis (TB) family contact. A prospective case-control study was undertaken to evaluate whether repeat bacille Calmette-Guérin (BCG) vaccination, nutritional state, presence/absence of BCG scar, and degree of AFB positivity of sputum of adult TB cases affect PPD skin reactivity in these two groups. Group I with TB contacts had larger induration (13.00 +/- 11.29 mm) than the Group II control group of 4.52 +/- 6.20; P = 0.000. Purified protein derivative reaction as to the number of BCG vaccination(s) received showed an increase in size as the BCG vaccination is repeated with significantly larger induration in Group I than in Group II (P = 0.048). The nutritional status was subgrouped into A (weight < 10 percentile), B (weight 50-75 percentile), and C (weight > 90 percentile), which were comparable for both groups. The mean PPD induration of subgroup A in Groups I and II was not statistically different. However, the mean PPD induration was highly significant between Groups I and II in subgroup B (12.46 +/- 10.70 vs 3.80 +/- 5.71 mm; P = 0.000) and subgroup C (14.31 +/- 11.54 vs 5.42 +/- 6.70 mm; P = 0.000). Children in group I with the BCG scar were noted to have significantly greater PPD induration size than in group II (14.14 +/- 11.23 vs 5.05 +/- 6.24 mm; P = 0.000). The degree of AFB positivity of sputum of TB adult cases (1+ to 4+ and cavitary TB) has no effect on PPD size (P = 0.766). Close contact with individuals with active TB (AFB smear positive) is a very important factor for PPD skin conversion. Repeat BCG vaccination, malnutrition, and BCG with scars present difficulties in making a diagnosis of TB infection but did not affect PPD reactivity and did highlight the need for thorough clinical evaluation.

  6. Diagnosis of penicillin allergy by skin testing: the Manitoba experience.

    PubMed Central

    Warrington, R. J.; Simons, F. E.; Ho, H. W.; Gorski, B. A.

    1978-01-01

    The reliability of skin testing in the diagnosis of penicillin allergy was studied in 86 adults and 167 children with a history of possible hypersensitivity reactions to penicillin. Skin testing was done with the major antigenic determinant of benzylpenicillin and minor determinants of benzylpenicillin, ampicillin, cloxacillin, methicillin and cephalothin. The overall frequency of positive skin reactions was 11.5%. Among the patients with positive skin reactions about half had a history of immediate or accelerated reactions to penicillins, but 2 of 11 adults and 50% of the children in this group had a history of maculopapular rash of delayed onset. There was a low frequency of positive skin reactions when there was a long interval between the times of clinical reaction and skin testing. Of 169 patients reacting negatively to skin testing who received a specific drug challenge only 2 manifested mild urticaria; this indicates the reliability of the skin tests in predicting penicillin allergy. The major and minor determinants of benzylpenicillin were the most useful reagents. One fifth of the patients with penicillin hypersensitivity would have been missed if the major determinant of benzylpenicillin alone had been used for skin testing. The additional use of the minor determinants of other penicillin derivatives, however, did not increase substantially the clinical reliability of the skin testing procedure. PMID:638909

  7. Advanced Development of Leishmania Topical Skin Test Antigen

    DTIC Science & Technology

    2012-09-28

    can cause sensitization manifest by the conversion of a negative to positive delayed-type hypersensitivity (DTH) skin test. This was observed on the...third skin test with 30 ug and 50 ug doses of the crude lysate administered intradermally at monthly intervals. Fractionation of the lysate...identified dominant proteins at 8 kDa, 20 kDa, and 56-58 kDa. Skin tests in L. tropica sensitized guinea pigs with each of these fractions revealed

  8. Airborne irritant contact dermatitis due to synthetic fibres from an air-conditioning filter.

    PubMed

    Patiwael, Jiska A; Wintzen, Marjolein; Rustemeyer, Thomas; Bruynzeel, Derk P

    2005-03-01

    We describe 8 cases of occupational airborne irritant contact dermatitis in intensive care unit (ICU) employees caused by synthetic (polypropylene and polyethylene) fibres from an air-conditioning filter. Not until a workplace investigation was conducted, was it possible to clarify the unusual sequence of events. High filter pressure in the intensive care air-conditioning system, maintained to establish an outward airflow and prevent microorganisms from entering the ward, probably caused fibres from the filter to become airborne. Upon contact with air-exposed skin, fibres subsequently provoked skin irritation. Test periods in the ICU with varying filter pressures, in an attempt to improve environmental conditions, led to even higher filter pressure levels and more complaints. The sometimes-very-low humidity might have contributed to development of skin irritation. The fact that most patients recovered quickly after treatment with emollients and changing the filters made it most likely that the airborne dermatitis was of an irritant nature.

  9. Establishment of a new in vitro test method for evaluation of eye irritancy using a reconstructed human corneal epithelial model, LabCyte CORNEA-MODEL.

    PubMed

    Katoh, Masakazu; Hamajima, Fumiyasu; Ogasawara, Takahiro; Hata, Ken-ichiro

    2013-12-01

    Finding in vitro eye irritation testing alternatives to animal testing such as the Draize eye test, which uses rabbits, is essential from the standpoint of animal welfare. It has been developed a reconstructed human corneal epithelial model, the LabCyte CORNEA-MODEL, which has a representative corneal epithelium-like structure. Protocol optimization (pre-validation study) was examined in order to establish a new alternative method for eye irritancy evaluation with this model. From the results of the optimization experiments, the application periods for chemicals were set at 1min for liquid chemicals or 24h for solid chemicals, and the post-exposure incubation periods were set at 24h for liquids or zero for solids. If the viability was less than 50%, the chemical was judged to be an eye irritant. Sixty-one chemicals were applied in the optimized protocol using the LabCyte CORNEA-MODEL and these results were evaluated in correlation with in vivo results. The predictions of the optimized LabCyte CORNEA-MODEL eye irritation test methods were highly correlated with in vivo eye irritation (sensitivity 100%, specificity 80.0%, and accuracy 91.8%). These results suggest that the LabCyte CORNEA-MODEL eye irritation test could be useful as an alternative method to the Draize eye test. Copyright © 2013 Elsevier Ltd. All rights reserved.

  10. Quantitative skin prick and bronchial provocation tests with platinum salt.

    PubMed Central

    Merget, R; Schultze-Werninghaus, G; Bode, F; Bergmann, E M; Zachgo, W; Meier-Sydow, J

    1991-01-01

    Occupational asthma due to platinum salts is a frequent disease in platinum refineries. The diagnosis is based upon a history of work related symptoms and a positive skin prick test with platinum salts. Bronchial provocation tests have not been performed in epidemiological studies because the skin test is believed to be highly specific and sensitive. As no reliable data about this issue currently exist, this study assesses the use of skin prick and bronchial provocation tests with methacholine and platinum salt in platinum refinery workers. Twenty seven of 35 workers, who were referred to our clinic with work related symptoms and nine control subjects with bronchial hyperreactivity underwent a skin prick test and bronchial provocation with methacholine and platinum salt. For skin prick and bronchial provocation tests with platinum salt a 10(-2)-10(-8) mol/l hexachloroplatinic acid solution, in 10-fold dilutions was used. Four of the 27 subjects and all controls showed neither a bronchial reaction nor a skin reaction. Twenty three subjects were considered allergic to platinum salt; 22 of these showed a fall of 50% or more in specific airway conductance after inhalation of the platinum salt solution. Four workers experienced a positive bronchial reaction despite a negative skin prick test. No correlation of responsiveness to methacholine with responsiveness to platinum salt was found, but the skin prick test correlated with the bronchial reaction to platinum salt (rs = 0.50, p less than 0.023, n = 22). One dual reaction was seen in bronchial provocation tests. Side effects of both skin tests and bronchial provocation tests with platinum salt were rare and were not encountered in workers without a skin reaction to platinum salt. It is concluded that bronchial provocation tests with platinum salts should be performed on workers with work related symptoms but negative skin tests with platinum salts. PMID:1772797

  11. The MOAHLFA index of irritant sodium lauryl sulfate reactions: first results of a multicentre study on routine sodium lauryl sulfate patch testing.

    PubMed

    Uter, Wolfgang; Geier, Johannes; Becker, Detlef; Brasch, Jochen; Löffler, Harald

    2004-01-01

    In a multicentre study of the German Contact Dermatitis Research Group, sodium lauryl sulfate (SLS) 0.25% and 0.5% aq. has been added to routine allergen patch tests to assess its properties as a convenient diagnostic indicator of individual susceptibility to irritation at the time of patch testing. Previous studies indicated that irritant SLS reactivity may be related to individual factors such as age and sex. As these factors are, in turn, among the important predictors of contact allergy to many allergens, e.g. summarized in the 'MOAHLFA index', the impact of the MOAHLFA factors on irritant SLS patch test reactivity, and thus a potential for confounding, was assessed in the 5971 participating patients. As a result of 2 logistic regression analyses with an irritant reaction to 0.25% and 0.5% SLS, respectively, as outcome, male sex was identified as a relatively weak but significant risk factor (OR 1.38), while age 40 years or older was an even weaker risk factor (OR 1.22 and 1.15, respectively). Upon detailed analysis, no clear age gradient could, however, be identified. 1-day exposure time almost halved the odds of an irritant SLS reaction. In conclusion, this type of SLS patch test can be regarded as robust, indicating individual irritability relatively independent from the individual factors analysed here.

  12. 4-Day evaluation of the irritation potential of topical desoximetasone 0.25% and 0.05% spray on light-exposed skin.

    PubMed

    Patel, Nupur U; Grammenos, Alexandra; Gowda, Asha; Onikoyi, Omobola; Feldman, Steven R

    2018-06-01

    The safety and potential side effects of desoximetasone 0.25% and 0.05% sprays have not previously been studied. The primary objective of this study was to determine the irritation potential of desoximetasone 0.25%, 0.05% and vehicle sprays in response to irradiation. Thirty-four subjects were enrolled in the study, each with three study treatments (desoximetasone 0.25%, 0.05% topical sprays and vehicle) were applied to two sites each on the back of every subject, with half of the sites irradiated with filtered UV light. Dermal reactions at the test sites were evaluated using a visual scale with corresponding numerical scores that rated the degree of erythema and oedema. Desoximetasone 0.25%, 0.05%, and vehicle caused no detectable signs of phototoxicity when examined on days 3 and 4. Mean scores of desoximetasone 0.25%, 0.05% and vehicle to non-irradiated treatment areas showed no signs of irritation. Our results suggest that regular application of desoximetasone 0.25% and 0.05% topical sprays do not induce photosensitization or photoirritation. The safety of this topical spray may help with clinical management of patients using topical corticosteroids while also receiving therapeutic UV light exposure. Thus, patients can use desoximetasone sprays without concerns of side effects due to therapeutic light or sun exposure.

  13. FROZEN RAW FOODS AS SKIN-TESTING MATERIALS—Further Studies of Use in Cases of Allergic Disorders

    PubMed Central

    Ancona, Giacomo R.; Schumacher, Irwin C.

    1954-01-01

    In further studies on the use of frozen raw food as skin-testing material in patients with allergic disorders, the results of previous work were confirmed in a greater number of subjects using a larger number of foods: Tests with frozen raw foods by the scratch method induce true positive reactions of a larger size and in greater frequency than the corresponding commercial extracts by either the scratch or the intracutaneous method. Storage in the frozen state for several years does not affect the antigenic potency of the materials. The frozen preparations have caused no harmful effects in the subjects, are free from irritant properties, and are not urticariogenic. PMID:13126823

  14. CON4EI: Bovine Corneal Opacity and Permeability (BCOP) test for hazard identification and labelling of eye irritating chemicals.

    PubMed

    Verstraelen, Sandra; Maglennon, Gareth; Hollanders, Karen; Boonen, Francis; Adriaens, Els; Alépée, Nathalie; Drzewiecka, Agnieszka; Gruszka, Katarzyna; Kandarova, Helena; Willoughby, Jamin A; Guest, Robert; Schofield, Jane; Van Rompay, An R

    2017-10-01

    Assessment of ocular irritation potential is an international regulatory requirement in the safety evaluation of industrial and consumer products. None in vitro ocular irritation assays are capable of fully categorizing chemicals as stand-alone. Therefore, the CEFIC-LRI-AIMT6-VITO CON4EI consortium assessed the reliability of eight in vitro test methods and computational models as well as established a tiered-testing strategy. One of the selected assays was Bovine Corneal Opacity and Permeability (BCOP). In this project, the same corneas were used for measurement of opacity using the OP-KIT, the Laser Light-Based Opacitometer (LLBO) and for histopathological analysis. The results show that the accuracy of the BCOP OP-KIT in identifying Cat 1 chemicals was 73.8% while the accuracy was 86.3% for No Cat chemicals. BCOP OP-KIT false negative results were often related to an in vivo classification driven by conjunctival effects only. For the BCOP LLBO, the accuracy in identifying Cat 1 chemicals was 74.4% versus 88.8% for No Cat chemicals. The BCOP LLBO seems very promising for the identification of No Cat liquids but less so for the identification of solids. Histopathology as an additional endpoint to the BCOP test method does not reduce the false negative rate substantially for in vivo Cat 1 chemicals. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. Development of the EpiOcular(TM) eye irritation test for hazard identification and labelling of eye irritating chemicals in response to the requirements of the EU cosmetics directive and REACH legislation.

    PubMed

    Kaluzhny, Yulia; Kandárová, Helena; Hayden, Patrick; Kubilus, Joseph; d'Argembeau-Thornton, Laurence; Klausner, Mitchell

    2011-09-01

    The recently implemented 7th Amendment to the EU Cosmetics Directive and the EU REACH legislation have heightened the need for in vitro ocular test methods. To address this need, the EpiOcular(TM) eye irritation test (EpiOcular-EIT), which utilises the normal (non-transformed) human cell-based EpiOcular tissue model, has been developed. The EpiOcular-EIT prediction model is based on an initial training set of 39 liquid and 21 solid test substances and uses a single exposure period and a single cut-off in tissue viability, as determined by the MTT assay. A chemical is classified as an irritant (GHS Category 1 or 2), if the tissue viability is ≤ 60%, and as a non-irritant (GHS unclassified), if the viability is > 60%. EpiOcular-EIT results for the training set, along with results for an additional 52 substances, which included a range of alcohols, hydrocarbons, amines, esters, and ketones, discriminated between ocular irritants and non-irritants with 98.1% sensitivity, 72.9% specificity, and 84.8% accuracy. To ensure the long-term commercial viability of the assay, EpiOcular tissues produced by using three alternative cell culture inserts were evaluated in the EpiOcular-EIT with 94 chemicals. The assay results obtained with the initial insert and the three alternative inserts were very similar, as judged by correlation coefficients (r²) that ranged from 0.82 to 0.96. The EpiOcular-EIT was pre-validated in 2007/2008, and is currently involved in a formal, multi-laboratory validation study sponsored by the European Cosmetics Association (COLIPA) under the auspices of the European Centre for the Validation of Alternative Methods (ECVAM). The EpiOcular-EIT, together with EpiOcular's long history of reproducibility and proven utility for ultra-mildness testing, make EpiOcular a useful model for addressing current legislation related to animal use in the testing of potential ocular irritants. 2011 FRAME.

  16. CON4EI: CONsortium for in vitro Eye Irritation testing strategy - EpiOcular™ time-to-toxicity (EpiOcular ET-50) protocols for hazard identification and labelling of eye irritating chemicals.

    PubMed

    Kandarova, Helena; Letasiova, Silvia; Adriaens, Els; Guest, Robert; Willoughby, Jamin A; Drzewiecka, Agnieszka; Gruszka, Katarzyna; Alépée, Nathalie; Verstraelen, Sandra; Van Rompay, An R

    2018-06-01

    Assessment of acute eye irritation potential is part of the international regulatory requirements for testing of chemicals. The objective of the CON4EI (CONsortium for in vitro Eye Irritation testing strategy) project was to develop tiered testing strategies for eye irritation assessment for all drivers of classification. A set of 80 reference chemicals (38 liquids and 42 solids) was tested with eight different alternative methods. Here, the results obtained with reconstructed human cornea-like epithelium (RhCE) EpiOcular™ in the EpiOcular time-to-toxicity Tests (Neat and Dilution ET-50 protocols) are presented. The primary aim of this study was to evaluate whether test methods can discriminate chemicals not requiring classification for serious eye damage/eye irritancy (No Category) from chemicals requiring classification and labelling for Category 1 and Category 2. In addition, the predictive capacity in terms of in vivo drivers of classification was investigated. The chemicals were tested in two independent runs by MatTek In Vitro Life Science Laboratories. Results of this study demonstrate very high specificity of both test protocols. With the existing prediction models described in the SOPs, the specificity of the Neat and Dilution method was 87% and 100%, respectively. The Dilution method was able to correctly predicting 66% of GHS Cat 2 chemicals, however, prediction of GHS Cat 1 chemicals was only 47%-55% using the current protocols. In order to achieve optimal prediction for all three classes, a testing strategy was developed which combines the most predictive time-points of both protocols and for tests liquids and solids separately. Using this new testing strategy, the sensitivity for predicting GHS Cat 1 and GHS Cat 2 chemicals was 73% and 64%, respectively and the very high specificity of 97% was maintained. None of the Cat 1 chemicals was underpredicted as GHS No Category. Further combination of the EpiOcular time-to-toxicity protocols with other

  17. CON4EI: Short Time Exposure (STE) test method for hazard identification and labelling of eye irritating chemicals.

    PubMed

    Adriaens, E; Willoughby, J A; Meyer, B R; Blakeman, L C; Alépée, N; Fochtman, P; Guest, R; Kandarova, H; Verstraelen, S; Van Rompay, A R

    2018-06-01

    Assessment of ocular irritancy is an international regulatory requirement in the safety evaluation of industrial and consumer products. Although many in vitro ocular irritation assays exist, alone they are incapable of fully categorizing chemicals. Therefore, the CEFIC-LRI-AIMT6-VITO CON4EI consortium was developed to assess the reliability of eight in vitro test methods and establish an optimal tiered-testing strategy. One assay selected was the Short Time Exposure (STE) assay. This assay measures the viability of SIRC rabbit corneal cells after 5min exposure to 5% and 0.05% solutions of test material, and is capable of categorizing of Category 1 and No Category chemicals. The accuracy of the STE test method to identify Cat 1 chemicals was 61.3% with 23.7% sensitivity and 95.2% specificity. If non-soluble chemicals and unqualified results were excluded, the performance to identify Cat 1 chemicals remained similar (accuracy 62.2% with 22.7% sensitivity and 100% specificity). The accuracy of the STE test method to identify No Cat chemicals was 72.5% with 66.2% sensitivity and 100% specificity. Excluding highly volatile chemicals, non-surfactant solids and non-qualified results resulted in an important improvement of the performance of the STE test method (accuracy 96.2% with 81.8% sensitivity and 100% specificity). Furthermore, it seems that solids are more difficult to test in the STE, 71.4% of the solids resulted in unqualified results (solubility issues and/or high variation between independent runs) whereas for liquids 13.2% of the results were not qualified, supporting the restriction of the test method regarding the testing of solids. Copyright © 2017. Published by Elsevier Ltd.

  18. Development of a forensic skin colour predictive test.

    PubMed

    Maroñas, Olalla; Phillips, Chris; Söchtig, Jens; Gomez-Tato, Antonio; Cruz, Raquel; Alvarez-Dios, José; de Cal, María Casares; Ruiz, Yarimar; Fondevila, Manuel; Carracedo, Ángel; Lareu, María V

    2014-11-01

    There is growing interest in skin colour prediction in the forensic field. However, a lack of consensus approaches for recording skin colour phenotype plus the complicating factors of epistatic effects, environmental influences such as exposure to the sun and unidentified genetic variants, present difficulties for the development of a forensic skin colour predictive test centred on the most strongly associated SNPs. Previous studies have analysed skin colour variation in single unadmixed population groups, including South Asians (Stokowski et al., 2007, Am. J. Hum. Genet, 81: 1119-32) and Europeans (Jacobs et al., 2013, Hum Genet. 132: 147-58). Nevertheless, a major challenge lies in the analysis of skin colour in admixed individuals, where co-ancestry proportions do not necessarily dictate any one person's skin colour. Our study sought to analyse genetic differences between African, European and admixed African-European subjects where direct spectrometric measurements and photographs of skin colour were made in parallel. We identified strong associations to skin colour variation in the subjects studied from a pigmentation SNP discovery panel of 59 markers and developed a forensic online classifier based on naïve Bayes analysis of the SNP profiles made. A skin colour predictive test is described using the ten most strongly associated SNPs in 8 genes linked to skin pigmentation variation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  19. Notes from the Field: Respiratory Symptoms and Skin Irritation Among Hospital Workers Using a New Disinfection Product - Pennsylvania, 2015.

    PubMed

    Hawley, Brie; Casey, Megan L; Cox-Ganser, Jean M; Edwards, Nicole; Fedan, Kathleen B; Cummings, Kristin J

    2016-04-22

    In March 2014, a new disinfection product, consisting of hydrogen peroxide, peroxyacetic acid, and acetic acid, was introduced at a Pennsylvania hospital to aid in the control of health care-associated infections. The product is an Environmental Protection Agency-registered non-bleach sporicide advertised as a one-step cleaner, disinfectant, and deodorizer. According to the manufacturer's safety data sheet, the product requires no personal protective equipment when it is diluted with water by an automated dispenser before use. On January 30, 2015, CDC's National Institute for Occupational Health (NIOSH) received a confidential employee request to conduct a health hazard evaluation at the hospital. The request cited concerns about exposure of hospital environmental services staff members to the product and reported symptoms among persons who had used the product that included eye and nasal problems, asthma-like symptoms, shortness of breath, skin problems, wheeze, chest tightness, and cough.

  20. Pyridostigmine bromide modulates topical irritant-induced cytokine release from human epidermal keratinocytes and isolated perfused porcine skin.

    PubMed

    Monteiro-Riviere, Nancy A; Baynes, Ronald E; Riviere, Jim E

    2003-02-01

    Gulf War personnel were given pyridostigmine bromide (PB) as a prophylactic treatment against organophosphate nerve agent exposure, and were exposed to the insecticide permethrin and the insect repellent N,N-diethyl-m-toluamide (DEET). The purpose of this study was to assess the effects of PB to modulate release of inflammatory biomarkers after topical chemical exposure to chemical mixtures containing permethrin and DEET applied in ethanol or water vehicles. Treatments were topically applied to isolated perfused porcine skin flaps (IPPSFs). Concentrations of interleukin-8 (IL-8), tumor necrosis factor-alpha (TNF-alpha) and prostaglandin E(2) (PGE(2)) were assayed in perfusate to probe for potential inflammatory effects after complex mixture application. IPPSFs (n=4/treatment) were topically dosed with mixtures of permethrin, DEET, and permethrin/DEET, in ethanol. Each treatment was repeated with perfusate spiked with 50 ng/ml of PB. Perfusate was also spiked with 30 ng/ml diisopropylfluorophosphate to simulate low level organophosphate nerve agent exposure. Timed IPPSF venous effluent samples (0.5,1,2,4, and 8 h) were assayed by ELISA for IL-8 and TNF-alpha and by EIA for PGE(2). Overall, PB infusion caused a decrease or IL-8 and PGE(2) release. Effects on TNF-alpha were vehicle dependent. To probe the potential mechanism of this PB effect, human epidermal keratinocyte HEK cell cultures were exposed to permethrin DEET permethrin/DEET, with and without PB in DMSO. IL-8 was assayed at 1, 2, 4, 8, 12 and 24 h. PB suppressed IL-8 in permethrin and ethanol treatment from 4 to 24 h confirming the IPPSF results. In conclusion, these studies suggest that systemic exposure to PB suppressed IL-8 release at multiple time points in two skin model systems. This interaction merits further study.

  1. Testing of Raman spectroscopy method for assessment of skin implants

    NASA Astrophysics Data System (ADS)

    Timchenko, E. V.; Timchenko, P. E.; Volova, L. T.; Pershutkina, S. V.; Shalkovskaya, P. Y.

    2016-11-01

    Results of studies of testing of Raman spectroscopy (RS) method for assessment of skin implants are presented. As objects of study were used samples of rat's skin material. The main spectral differences of implants using various types of their processing appear at wavenumbers 1062 cm-1, 1645 cm-1, 1553 cm-1, 851 cm-1, 863 cm-1, 814 cm-1 and 1410 cm-1. Optical coefficients for assessment of skin implants were introduced. The research results are confirmed by morphological analysis.

  2. Predictive performance and inter-laboratory reproducibility in assessing eye irritation potential of water- and oil-soluble mixtures using the Short Time Exposure test method.

    PubMed

    Abo, Takayuki; Hilberer, Allison; Behle-Wagner, Christine; Watanabe, Mika; Cameron, David; Kirst, Annette; Nukada, Yuko; Yuki, Takuo; Araki, Daisuke; Sakaguchi, Hitoshi; Itagaki, Hiroshi

    2018-04-01

    The Short Time Exposure (STE) test method is an alternative method for assessing eye irritation potential using Statens Seruminstitut Rabbit Cornea cells and has been adopted as test guideline 491 by the Organisation for Economic Co-operation and Development. Its good predictive performance in identifying the Globally Harmonized System (GHS) No Category (NC) or Irritant Category has been demonstrated in evaluations of water-soluble substances, oil-soluble substances, and water-soluble mixtures. However, the predictive performance for oil-soluble mixtures was not evaluated. Twenty-four oil-soluble mixtures were evaluated using the STE test method. The GHS NC or Irritant Category of 22 oil-soluble mixtures were consistent with that of a Reconstructed human Cornea-like Epithelium (RhCE) test method. Inter-laboratory reproducibility was then confirmed using 20 water- and oil-soluble mixtures blind-coded. The concordance in GHS NC or Irritant Category among four laboratories was 90%-100%. In conclusion, the concordance in comparison with the results of RhCE test method using 24 oil-soluble mixtures and inter-laboratory reproducibility using 20 water- and oil-soluble mixtures blind-coded were good, indicating that the STE test method is a suitable alternative for predicting the eye irritation potential of both substances and mixtures. Copyright © 2018 Elsevier Ltd. All rights reserved.

  3. Prediction of ocular irritancy of 26 chemicals and 26 cosmetic products with isolated rabbit eye (IRE) test.

    PubMed

    Guo, Xiang; Yang, Xing Fen; Yang, Ying; Hans, Raabe; Cai, Jing Heng; Xue, Jin Yu; Tan, Xiao Hua; Xie, Xiao Ping; Xiong, Xi Kun; Huang, Jun Ming

    2012-06-01

    This study aims to establish and evaluate the methodology of isolated rabbit eye (IRE) test. IRE test was performed according to modifications of the in vitro toxicology (INVITTOX) Protocol No.85: Rabbit enucleated eye test by European Centre for the Validation of Alternative Methods (ECVAM), and then 26 chemicals and 26 cosmetic products were tested in both in vitro IRE and in vivo Draize tests. A statistical analysis was conducted to determine the relevance of the IRE test to the data generated in the Draize test. IRE test was established successfully in our laboratory. It was shown that ranking correlation and class concordance were fairly well between the IRE test and the Draize test for 26 reference chemicals (Fisher's Exact Test χ(2)=51.314, P<0.001; McNemar P=0.261; Gamma=0.960, P<0.001; Kappa=0.843, P<0.001) and 26 cosmetic products (Fisher's Exact Test χ(2)=15.522, P<0.001; McNemar P=0.311; Gamma=0.967, P<0.001; Kappa=0.611, P<0.001). IRE test was established successfully for in vitro testing of eye irritation as an alternative to Draize test. Copyright © 2012 The Editorial Board of Biomedical and Environmental Sciences. Published by Elsevier B.V. All rights reserved.

  4. An intradermal skin test for determination of immunity to varicella

    PubMed Central

    Somekh, E; Bujanover, Y; Tal, G; Dalal, I; Tanay, A; Lehman, D

    2001-01-01

    AIMS—To evaluate the usefulness of a diluted, inactivated solution of attenuated varicella vaccine in predicting susceptibility to varicella and its correlation with specific antibody titre to varicella.
METHODS—In a prospective blinded study, 63 healthy subjects (aged 2-43 years) were studied. Skin test solution was prepared from vials of OKA strain virus which was inactivated by exposure of the vials to room temperature for 10 days; solution was diluted at 1/50 with normal saline and kept at 4°C until used for skin testing. The material was injected intradermally. Serum samples were drawn prior to skin testing and kept at −70°C until analysis for antibody assay by the indirect fluorescent antibody (IFA) method.
RESULTS—Forty three patients were IFA antibody positive; 41 of them reacted to the skin test. One of the 20 IFA negative patients reacted to the skin test. Sixteen patients had two serological tests performed, one month apart. Four out of these 16 patients tested negative with the skin test. All four had negative serology on both samples. Six of the 12 IFA positive patients showed a boost in the antibody titre one month after application of the skin test. The specificity and sensitivity of the skin test compared to the IFA assay were both 95%, and the positive and negative predictive values were 97% and 90% respectively.
CONCLUSIONS—Results suggest that a varicella skin test prepared using this simple and relatively cheap method is a safe, sensitive, and specific tool by which to assess immunity to varicella.

 PMID:11719333

  5. Elective penicillin skin testing in a pediatric outpatient setting.

    PubMed

    Jost, Barbara Capes; Wedner, H James; Bloomberg, Gordon R

    2006-12-01

    Adverse reactions associated with penicillin-type antibiotics are common in pediatric practice, leading to the subsequent unnecessary use of alternative antibiotics. IgE-mediated penicillin allergy represents only a fraction of these adverse reactions. To examine (1) the trend of penicillin skin test reactivity during a recent 10-year interval, (2) the relative distribution of specific reagents related to a positive skin test result, and (3) skin test reactivity as a function of reaction history. Penicillin testing using 3 reagents--benzylpenicilloyl polylysine, penicillin G, and sodium penicilloate (penicillin A)--was conducted in a prospective study of 359 consecutive patients referred to an outpatient pediatric allergy clinic between January 1, 1993, and May 31, 2003. We also retrospectively reviewed penicillin skin test results for 562 children previously tested between January 1, 1979, and December 31, 1992. Between 1993 and 2003, the prevalence of penicillin skin test sensitivity markedly declined. Of all the positive skin test results between 1979 and 2002, either penicillin G or sodium penicilloate or both identified 34%, with sodium penicilloate alone responsible for 8.5%. The rate of positive skin test reactions was not significantly different between patients with vs without a history of suggestive IgE-mediated reactions. A marked decline in penicillin skin test sensitivity in the pediatric age group is identified. The minor determinant reagents penicillin G and sodium penicilloate are both necessary for determining potential penicillin allergy. Relating history alone to potential penicillin sensitivity is unreliable in predicting the presence or absence of a positive skin test result.

  6. Intradermal Skin Testing in Allergic Rhinitis and Asthma with Negative Skin Prick Tests.

    PubMed

    Erel, Fuat; Sarioglu, Nurhan; Kose, Mehmet; Kaymakci, Mustafa; Gokcen, Mucahide; Kepekci, Ahmet Hamdi; Arslan, Mehmet

    2017-06-01

    Taking medical history, physical examination, and performing some in vivo and in vitro tests are necessary for the diagnosis of allergy. Skin prick test (SPT) is considered as the standard method and first-line approach for the detection of allergic sensitization. Although mainly SPT is used for the detection of allergic sensitization, intradermal skin test (IDST) may be necessary, especially in patients with a negative SPT result. IDST is quite safe; however, is nowadays seldom used for detection of inhalant allergy and its value remains controversial. We aimed to investigate whether IDST is useful and necessary in diagnosis of respiratory allergies or not. This study involved 4223 patients with allergic rhinitis (AR) and/or bronchial asthma (BA). SPT results were positive in 2419 patients (57%) and negative in 1804 (43%). IDST was applied to 344 patients with marked allergic symptoms and with negative SPT results. Out of 344 patients, 152 (44%) showed allergic sensitization to IDST. The most commonly encountered allergic response was against the house dust mite (HDM) (32.6%). Allergic response against fungal spores was also relatively high (22%), while the pollen allergy rate (4.3%) was quite low. In BA patients with negative prick test, IDST made a significant contribution to the diagnosis of HDM allergy (p=0.003). To avoid missed diagnosis of AR and BA, particularly regarding  the HDM allergy, application of IDST may be beneficial; therefore, IDST should be considered as the next step after SPT for diagnosis of allergy prior to in vitro or provocation tests.

  7. Skin Testing for Allergic Rhinitis: A Health Technology Assessment

    PubMed Central

    Kabali, Conrad; Chan, Brian; Higgins, Caroline; Holubowich, Corinne

    2016-01-01

    Background Allergic rhinitis is the most common type of allergy worldwide. The accuracy of skin testing for allergic rhinitis is still debated. This health technology assessment had two objectives: to determine the diagnostic accuracy of skin-prick and intradermal testing in patients with suspected allergic rhinitis and to estimate the costs to the Ontario health system of skin testing for allergic rhinitis. Methods We searched All Ovid MEDLINE, Embase, and Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, CRD Health Technology Assessment Database, Cochrane Central Register of Controlled Trials, and NHS Economic Evaluation Database for studies that evaluated the diagnostic accuracy of skin-prick and intradermal testing for allergic rhinitis using nasal provocation as the reference standard. For the clinical evidence review, data extraction and quality assessment were performed using the QUADAS-2 tool. We used the bivariate random-effects model for meta-analysis. For the economic evidence review, we assessed studies using a modified checklist developed by the (United Kingdom) National Institute for Health and Care Excellence. We estimated the annual cost of skin testing for allergic rhinitis in Ontario for 2015 to 2017 using provincial data on testing volumes and costs. Results We meta-analyzed seven studies with a total of 430 patients that assessed the accuracy of skin-prick testing. The pooled pair of sensitivity and specificity for skin-prick testing was 85% and 77%, respectively. We did not perform a meta-analysis for the diagnostic accuracy of intradermal testing due to the small number of studies (n = 4). Of these, two evaluated the accuracy of intradermal testing in confirming negative skin-prick testing results, with sensitivity ranging from 27% to 50% and specificity ranging from 60% to 100%. The other two studies evaluated the accuracy of intradermal testing as a stand-alone tool for diagnosing allergic rhinitis, with

  8. Skin Testing for Allergic Rhinitis: A Health Technology Assessment.

    PubMed

    2016-01-01

    Allergic rhinitis is the most common type of allergy worldwide. The accuracy of skin testing for allergic rhinitis is still debated. This health technology assessment had two objectives: to determine the diagnostic accuracy of skin-prick and intradermal testing in patients with suspected allergic rhinitis and to estimate the costs to the Ontario health system of skin testing for allergic rhinitis. We searched All Ovid MEDLINE, Embase, and Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, CRD Health Technology Assessment Database, Cochrane Central Register of Controlled Trials, and NHS Economic Evaluation Database for studies that evaluated the diagnostic accuracy of skin-prick and intradermal testing for allergic rhinitis using nasal provocation as the reference standard. For the clinical evidence review, data extraction and quality assessment were performed using the QUADAS-2 tool. We used the bivariate random-effects model for meta-analysis. For the economic evidence review, we assessed studies using a modified checklist developed by the (United Kingdom) National Institute for Health and Care Excellence. We estimated the annual cost of skin testing for allergic rhinitis in Ontario for 2015 to 2017 using provincial data on testing volumes and costs. We meta-analyzed seven studies with a total of 430 patients that assessed the accuracy of skin-prick testing. The pooled pair of sensitivity and specificity for skin-prick testing was 85% and 77%, respectively. We did not perform a meta-analysis for the diagnostic accuracy of intradermal testing due to the small number of studies (n = 4). Of these, two evaluated the accuracy of intradermal testing in confirming negative skin-prick testing results, with sensitivity ranging from 27% to 50% and specificity ranging from 60% to 100%. The other two studies evaluated the accuracy of intradermal testing as a stand-alone tool for diagnosing allergic rhinitis, with sensitivity ranging from 60

  9. Comparison of in vitro eye irritation potential by bovine corneal opacity and permeability (BCOP) assay to erythema scores in human eye sting test of surfactant-based formulations.

    PubMed

    Cater, Kathleen C; Harbell, John W

    2008-01-01

    The bovine corneal opacity and permeability (BCOP) assay can be used to predict relative eye irritation potential of surfactant-based personal care formulations relative to a corporate benchmark. The human eye sting test is typically used to evaluate product claims of no tears/no stinging for children's bath products. A preliminary investigation was conducted to test a hypothesis that the BCOP assay could be used as a prediction model for relative ranking of human eye irritation responses under conditions of a standard human eye sting test to surfactant-based formulations. BCOP assays and human eye sting tests were conducted on 4 commercial and 1 prototype body wash (BW) developed specifically for children or as mild bath products. In the human eye sting test, 10 mul of a 10% dosing solution is instilled into one eye of each panelist (n = 20), and the contralateral eye is dosed with sterile water as a control. Bulbar conjunctival erythema responses of each eye are graded at 30 seconds by an ophthalmologist. The BCOP assay permeability values (optical density at 490 nm [OD(490)]) for the 5 BWs ranged from 0.438 to 1.252 (i.e., least to most irritating). By comparison, the number of panelists exhibiting erythema responses (mild to moderately pink) ranged from 3 of 20 panelists for the least irritating BW to 10 of 20 panelists for the most irritating BW tested. The relative ranking of eye irritation potential of the 5 BWs in the BCOP assay compares favorably with the relative ranking of the BWs in the human eye sting test. Based on these findings, the permeability endpoint of the BCOP assay, as described for surfactant-based formulations, showed promise as a prediction model for relative ranking of conjunctival erythema responses in the human eye. Consequently, screening of prototype formulations in the BCOP assay would allow for formula optimization of mild bath products prior to investment in a human eye sting test.

  10. The isolated chicken eye test as a suitable in vitro method for determining the eye irritation potential of household cleaning products.

    PubMed

    Schutte, K; Prinsen, M K; McNamee, P M; Roggeband, R

    2009-08-01

    Eye irritation is an important endpoint in the safety evaluation of consumer products and their ingredients. Several in vitro methods have been developed and are used by different industry sectors to assess eye irritation. One such in vitro method in use for some time already is the isolated chicken eye test (ICE). This investigation focuses on assessing the ICE as a method to determine the eye irritation potential of household cleaning products, both for product safety assurance prior to marketing and for classification and labeling decisions. The ICE involves a single application of test substances onto the cornea of isolated chicken eyes. Endpoints are corneal swelling, corneal opacity and fluorescein retention. The ICE results were compared to historic LVET data in this study due to availability of such in vivo data and the ability to correlate LVET to human experience data on the outcome of accidental exposures to household cleaning products in general. The results of this study indicate that the ICE test is a useful in vitro method for evaluating the eye irritation/corrosion potential and establishing classification and labeling for household cleaning products. For new product formulations, it is best used as part of a weight-of-evidence approach and benchmarked against data from comparable formulations with known eye irritation/corrosion profiles and market experience.

  11. LLNA variability: An essential ingredient for a comprehensive assessment of non-animal skin sensitization test methods and strategies.

    PubMed

    Hoffmann, Sebastian

    2015-01-01

    The development of non-animal skin sensitization test methods and strategies is quickly progressing. Either individually or in combination, the predictive capacity is usually described in comparison to local lymph node assay (LLNA) results. In this process the important lesson from other endpoints, such as skin or eye irritation, to account for variability reference test results - here the LLNA - has not yet been fully acknowledged. In order to provide assessors as well as method and strategy developers with appropriate estimates, we investigated the variability of EC3 values from repeated substance testing using the publicly available NICEATM (NTP Interagency Center for the Evaluation of Alternative Toxicological Methods) LLNA database. Repeat experiments for more than 60 substances were analyzed - once taking the vehicle into account and once combining data over all vehicles. In general, variability was higher when different vehicles were used. In terms of skin sensitization potential, i.e., discriminating sensitizer from non-sensitizers, the false positive rate ranged from 14-20%, while the false negative rate was 4-5%. In terms of skin sensitization potency, the rate to assign a substance to the next higher or next lower potency class was approx.10-15%. In addition, general estimates for EC3 variability are provided that can be used for modelling purposes. With our analysis we stress the importance of considering the LLNA variability in the assessment of skin sensitization test methods and strategies and provide estimates thereof.

  12. A controlled, three-part trial to investigate the barrier function and skin hydration properties of six skin protectants.

    PubMed

    Hoggarth, Andrew; Waring, Mike; Alexander, James; Greenwood, Amanada; Callaghan, Theresa

    2005-12-01

    In the treatment of incontinence dermatitis, a skin protectant primarily prevents skin breakdown due to moisture and biological irritants in urine and feces. To assess the barrier and skin hydration properties of six currently available skin protectants with different formulations, a controlled, three-phase study was conducted at a research facility in the UK among 18 healthy volunteers. The study addressed each product's efficacy against insult from a known irritant (sodium lauryl sulphate), skin hydration potential, and maintenance of skin barrier and barrier efficacy against maceration. Using white petrolatum (glycerin) as the positive control and untreated sites as the negative control, the results show that each one of the products tested has different performance properties. Products containing petrolatum demonstrated protection against irritants (P = 0.006 at 24 hours) and maceration (P < 0.005) and provided some skin hydration. Products containing dimethicone varied in protection against irritants (P < 0.005, or P > or = 0.806 at 24 hours) and have good skin hydration potential and low barrier efficacy (P > 0.500). Zinc oxide-based products showed protection against irritants (P < 0.005) but poor skin hydration and barrier properties to prevent maceration (P = 0.262). Overall, only the water-in-oil petrolatum- based product performed effectively within all the parameters tested. This study suggests that skin barrier protection involves more than the inclusion of an active barrier ingredient. Further testing and use of barrier products in the clinical setting will provide additional evidence for appropriate product selection.

  13. Using the Slug Mucosal Irritation Assay to Investigate the Tolerability of Tablet Excipients on Human Skin in the Context of the Use of a Nipple Shield Delivery System.

    PubMed

    Kendall, Richard; Lenoir, Joke; Gerrard, Stephen; Scheuerle, Rebekah L; Slater, Nigel K H; Tuleu, Catherine

    2017-04-01

    Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified nipple shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form METHODS: Zinc sulphate selected as the antidiarrheal model drug that reduces infant mortality, was blended with functional excipients at traditional levels [microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate]. Slugs were exposed to blends slurried in human breast milk to assess their stinging, itching or burning potential, using objective values such as mucus production to categorize irritation potency RESULTS: Presently an in vivo assay, previously validated for prediction of ocular and nasal irritation, was used as an alternative to vertebrate models to anticipate the potential maternal dermatological tolerability issues to NSDS tablet components. The excipients did not elicit irritancy. However, mild irritancy was observed when zinc sulphate was present in blends. These promising good tolerability results support the continued investigation of these excipients within NSDS rapidly disintegrating tablet formulations. Topical local tolerance effects being almost entirely limited to irritation, the slug assay potentially adds to the existing preformulation toolbox, and may sit in between the in vitro and existing in vivo assays.

  14. [Skin prick testing versus immumofluorescence testing for mites allergens].

    PubMed

    Zhang, Yong; Wang, Zhiyi; Chen, Wei; Ji, Junfeng; Wang, Tianyou; Wang, Qiuping; Li, Zeqing

    2012-03-01

    To discuss the characteristics of skin prick test (SPT) and immumofluorescence method (IFM) in detecting the atopy of dermatophagoides pteronyssinus (Dp) and dermatophagoides farinae (Df)and explore the relationship of them. Four hundred and ninety-one patients with two or more symptoms of nasal obstruction,itching, sneezing and rhinorrhea received SPT and serum specific IgE detection using IFM. SPT was more sensitive than IFM in detecting the atopy of Dp and Df (P < 0.05). If using the IFM as the gold standard, the sensitivity of SPT was all above 95% with the specificity a little bit lower than 80%. These two methods had a positive correlation in detecting the atopy of Dp and Df (r = 0.779, 0.776; P < 0.01). The sIgE concentrations of these two mites were highly correlated with each other (r = 0.954, P < 0.01), the SPT was highly correlated with each other (r = 0. 946, P < 0.01). SPT was more sensitive than IFM in detecting the atopy of Dp and Df. In most cases, SPT can replace IFM to detect patients' allergia on mites. Besides, it is good enough to detect either of the serum specific IgE concentrations of Dp and Df.

  15. Evaluation of three different histamine concentrations in intradermal testing of normal cats and attempted determination of 'irritant' threshold concentrations for 48 allergens.

    PubMed

    Austel, Michaela; Hensel, Patrick; Jackson, Dawn; Vidyashankar, Anand; Zhao, Ying; Medleau, Linda

    2006-06-01

    The purpose of this study was to determine the optimal histamine concentration and 'irritant' allergen threshold concentrations in intradermal testing (IDT) in normal cats. Thirty healthy cats were tested with three different histamine concentrations and four different concentrations of each allergen. The optimal histamine concentration was determined to be 1: 50,000 w/v (0.05 mg mL(-1)). Using this histamine concentration, the 'irritant' threshold concentration for most allergens was above the highest concentrations tested (4,000 PNU mL(-1) for 41 allergens and 700 PNU mL(-1) for human dander). The 'irritant' threshold concentration for flea antigen was determined to be 1:750 w/v. More than 10% of the tested cats showed positive reactions to Dermatophagoides farinae, Dermatophagoides pteronyssinus, housefly, mosquito and moth at every allergen concentration, which suggests that the 'irritant' threshold concentration for these allergens is below 1,000 PNU mL(-1), the lowest allergen concentration tested. Our results confirm previous studies in indicating that allergen and histamine concentrations used in feline IDT may need to be revised.

  16. Bacterial cellulose skin masks-Properties and sensory tests.

    PubMed

    Pacheco, Guilherme; de Mello, Carolina Véspoli; Chiari-Andréo, Bruna Galdorfini; Isaac, Vera Lucia Borges; Ribeiro, Sidney José Lima; Pecoraro, Édison; Trovatti, Eliane

    2017-09-29

    Bacterial cellulose (BC) is a versatile material produced by microorganisms in the form of a membranous hydrogel, totally biocompatible, and endowed with high mechanical strength. Its high water-holding capacity based on its highly porous nanofibrillar structure allows BC to incorporate and to release substances very fast, thus being suitable for the preparation of skincare masks. The preparation and characterization of cosmetic masks based on BC membranes and active cosmetics. The masks were prepared by the simple incorporation of the cosmetic actives into BC membranes, used as a swelling matrix. The masks were characterized by Fourier transform infrared (FTIR), scanning electron microscopy (SEM), sensory tests, and skin moisture tests on volunteers. The results of sensory tests revealed the good performance of BC, being considered effective by the panel of volunteers, specially for adhesion to the skin (7.7 at the score scale), and improvement of the skin moisture (the hydration effect increased 76% in 75% of the volunteers that used vegetable extract mask formulation [VEM]), or a decrease in skin hydration (80% of the volunteers showed 32.6% decrease on skin hydration using propolis extract formulation [PEM] treatment), indicating the BC nanofiber membranes can be used to skincare applications. The results demonstrate the BC can be used as an alternative support for cosmetic actives for skin treatment. © 2017 Wiley Periodicals, Inc.

  17. Further development of LLNA:DAE method as stand-alone skin-sensitization testing method and applied for evaluation of relative skin-sensitizing potency between chemicals.

    PubMed

    Yamashita, Kunihiko; Shinoda, Shinsuke; Hagiwara, Saori; Itagaki, Hiroshi

    2015-04-01

    To date, there has been no well-established local lymph node assay (LLNA) that includes an elicitation phase. Therefore, we developed a modified local lymph node assay with an elicitation phase (LLNA:DAE) to discriminate true skin sensitizers from chemicals that gave borderline positive results and previously reported this assay. To develop the LLNA:DAE method as a useful stand-alone testing method, we investigated the complete procedure for the LLNA:DAE method using hexyl cinnamic aldehyde (HCA), isoeugenol, and 2,4-dinitrochlorobenzene (DNCB) as test compounds. We defined the LLNA:DAE procedure as follows: in the dose-finding test, four concentrations of chemical applied to dorsum of the right ear on days 1, 2, and 3 and dorsum of both ears on day 10. Ear thickness and skin irritation score were measured on days 1, 3, 5, 10, and 12. Local lymph nodes were excised and weighed on day 12. The test dose for the primary LLNA:DAE study was selected as the dose that gave the highest left ear lymph node weight in the dose-finding study, or the lowest dose that produced a left ear lymph node of over 4 mg. This procedure was validated using nine different chemicals. Furthermore, qualitative relationship was observed between the degree of elicitation response in the left ear lymph node and the skin sensitizing potency of 32 chemicals tested in this study and the previous study. These results indicated that LLNA:DAE method was as first LLNA method that was able to evaluate the skin sensitizing potential and potency in elicitation response.

  18. A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: eye irritation.

    PubMed

    McNamee, Pauline; Hibatallah, Jalila; Costabel-Farkas, Margit; Goebel, Carsten; Araki, Daisuke; Dufour, Eric; Hewitt, Nicola J; Jones, Penny; Kirst, Annette; Le Varlet, Béatrice; Macfarlane, Martin; Marrec-Fairley, Monique; Rowland, Joanna; Schellauf, Florian; Scheel, Julia

    2009-07-01

    The need for alternative approaches to replace the in vivo rabbit Draize eye test for evaluation of eye irritation of cosmetic ingredients has been recognised by the cosmetics industry for many years. Extensive research has lead to the development of several assays, some of which have undergone formal validation. Even though, to date, no single in vitro assay has been validated as a full replacement for the rabbit Draize eye test, organotypic assays are accepted for specific and limited regulatory purposes. Although not formally validated, several other in vitro models have been used for over a decade by the cosmetics industry as valuable tools in a weight of evidence approach for the safety assessment of ingredients and finished products. In light of the deadlines established in the EU Cosmetics Directive for cessation of animal testing for cosmetic ingredients, a COLIPA scientific meeting was held in Brussels on 30th January, 2008 to review the use of alternative approaches and to set up a decision-tree approach for their integration into tiered testing strategies for hazard and safety assessment of cosmetic ingredients and their use in products. Furthermore, recommendations are given on how remaining data gaps and research needs can be addressed.

  19. 16 CFR 1500.41 - Method of testing primary irritant substances.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... corrosivity properties of substances, including testing that does not require animals, are presented in the CPSC's animal testing policy set forth in 16 CFR 1500.232. A weight-of-evidence analysis or a validated... conducted, a sequential testing strategy is recommended to reduce the number of test animals. The method of...

  20. Adverse reactions to cosmetics and methods of testing.

    PubMed

    Nigam, P K

    2009-01-01

    Untoward reactions to cosmetics, toiletries, and topical applications are the commonest single reason for hospital referrals with allergic contact dermatitis. In most cases, these are only mild or transient and most reactions being irritant rather than allergic in nature. Various adverse effects may occur in the form of acute toxicity, percutaneous absorption, skin irritation, eye irritation, skin sensitization and photosensitization, subchronic toxicity, mutagenicity/genotoxicity, and phototoxicity/photoirritation. The safety assessment of a cosmetic product clearly depends upon how it is used, since it determines the amount of substance which may be ingested, inhaled, or absorbed through the skin or mucous membranes. Concentration of ingredients used in the different products is also important. Various test procedures include in vivo animal models and in vitro models, such as open or closed patch test, in vivo skin irritation test, skin corrosivity potential tests (rat skin transcutaneous electrical resistance test, Episkin test), eye irritation tests (in vivo eye irritancy test and Draize eye irritancy test), mutagenicity/genotoxicity tests (in vitro bacterial reverse mutation test and in vitro mammalian cell chromosome aberration test), and phototoxicity/photoirritation test (3T3 neutral red uptake phototoxicity test). Finished cosmetic products are usually tested in small populations to confirm the skin and mucous membrane compatibility, and to assess their cosmetic acceptability.

  1. Irritable Bowel Syndrome

    MedlinePlus

    ... Staying Safe Videos for Educators Search English Español Irritable Bowel Syndrome KidsHealth / For Teens / Irritable Bowel Syndrome What's in ... intestinal disorder called irritable bowel syndrome. What Is Irritable Bowel Syndrome? Irritable bowel syndrome (IBS) is a common intestinal ...

  2. Estimating Skin Cancer Risk: Evaluating Mobile Computer-Adaptive Testing.

    PubMed

    Djaja, Ngadiman; Janda, Monika; Olsen, Catherine M; Whiteman, David C; Chien, Tsair-Wei

    2016-01-22

    Response burden is a major detriment to questionnaire completion rates. Computer adaptive testing may offer advantages over non-adaptive testing, including reduction of numbers of items required for precise measurement. Our aim was to compare the efficiency of non-adaptive (NAT) and computer adaptive testing (CAT) facilitated by Partial Credit Model (PCM)-derived calibration to estimate skin cancer risk. We used a random sample from a population-based Australian cohort study of skin cancer risk (N=43,794). All 30 items of the skin cancer risk scale were calibrated with the Rasch PCM. A total of 1000 cases generated following a normal distribution (mean [SD] 0 [1]) were simulated using three Rasch models with three fixed-item (dichotomous, rating scale, and partial credit) scenarios, respectively. We calculated the comparative efficiency and precision of CAT and NAT (shortening of questionnaire length and the count difference number ratio less than 5% using independent t tests). We found that use of CAT led to smaller person standard error of the estimated measure than NAT, with substantially higher efficiency but no loss of precision, reducing response burden by 48%, 66%, and 66% for dichotomous, Rating Scale Model, and PCM models, respectively. CAT-based administrations of the skin cancer risk scale could substantially reduce participant burden without compromising measurement precision. A mobile computer adaptive test was developed to help people efficiently assess their skin cancer risk.

  3. Skin care and incontinence

    MedlinePlus

    ... skin problems such as redness, peeling, irritation, and yeast infections likely. Bedsores ( pressure sores ) may also develop ... drying the skin. Incontinence problems can cause a yeast infection on the skin. This is an itchy, ...

  4. Small intestinal bacterial overgrowth as an uncommon cause of false positive lactose hydrogen breath test among patients with diarrhea-predominant irritable bowel syndrome in Asia.

    PubMed

    Wang, Yilin; Xiong, Lishou; Gong, Xiaorong; Li, Weimin; Zhang, Xiangsong; Chen, Minhu

    2015-06-01

    It has been reported that small intestinal bacterial overgrowth (SIBO) may lead to false positive diagnoses of lactose malabsorption (LM) in irritable bowel syndrome patients. The aim of this study was to determine the influence of SIBO on lactose hydrogen breath test (HBT) results in these patients. Diarrhea-predominant irritable bowel syndrome patients with abnormal lactose HBTs ingested a test meal containing (99m) Tc and lactose. The location of the test meal and the breath levels of hydrogen were recorded simultaneously by scintigraphic scanning and lactose HBT, respectively. The increase in hydrogen concentration was not considered to be caused by SIBO if ≥ 10% of (99m) Tc accumulated in the cecal region at the time or before of abnormal lactose HBT. LM was present in 84% (31/37) of irritable bowel syndrome patients. Twenty of these patients agreed to measurement of oro-cecal transit time. Only three patients (15%) with abnormal lactose HBT might have had SIBO. The median oro-cecal transit time between LM and lactose intolerance patients were 75 min and 45 min, respectively (Z=2.545, P=0.011). Most of irritable bowel syndrome patients with an abnormal lactose HBT had LM. SIBO had little impact on the interpretation of lactose HBTs. The patients with lactose intolerance had faster small intestinal transit than LM patients. © 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

  5. Four-sample lactose hydrogen breath test for diagnosis of lactose malabsorption in irritable bowel syndrome patients with diarrhea

    PubMed Central

    Yang, Jian-Feng; Fox, Mark; Chu, Hua; Zheng, Xia; Long, Yan-Qin; Pohl, Daniel; Fried, Michael; Dai, Ning

    2015-01-01

    AIM: To validate 4-sample lactose hydrogen breath testing (4SLHBT) compared to standard 13-sample LHBT in the clinical setting. METHODS: Irritable bowel syndrome patients with diarrhea (IBS-D) and healthy volunteers (HVs) were enrolled and received a 10 g, 20 g, or 40 g dose lactose hydrogen breath test (LHBT) in a randomized, double-blinded, controlled trial. The lactase gene promoter region was sequenced. Breath samples and symptoms were acquired at baseline and every 15 min for 3 h (13 measurements). The detection rates of lactose malabsorption (LM) and lactose intolerance (LI) for a 4SLHBT that acquired four measurements at 0, 90, 120, and 180 min from the same data set were compared with the results of standard LHBT. RESULTS: Sixty IBS-D patients and 60 HVs were studied. The genotype in all participants was C/C-13910. LM and LI detection rates increased with lactose dose from 10 g, 20 g to 40 g in both groups (P < 0.001). 4SLHBT showed excellent diagnostic concordance with standard LHBT (97%-100%, Kappa​​ 0.815-0.942) with high sensitivity (90%-100%) and specificity (100%) at all three lactose doses in both groups. CONCLUSION: Reducing the number of measurements from 13 to 4 samples did not significantly impact on the accuracy of LHBT in health and IBS-D. 4SLHBT is a valid test for assessment of LM and LI in clinical practice. PMID:26140004

  6. Four-sample lactose hydrogen breath test for diagnosis of lactose malabsorption in irritable bowel syndrome patients with diarrhea.

    PubMed

    Yang, Jian-Feng; Fox, Mark; Chu, Hua; Zheng, Xia; Long, Yan-Qin; Pohl, Daniel; Fried, Michael; Dai, Ning

    2015-06-28

    To validate 4-sample lactose hydrogen breath testing (4SLHBT) compared to standard 13-sample LHBT in the clinical setting. Irritable bowel syndrome patients with diarrhea (IBS-D) and healthy volunteers (HVs) were enrolled and received a 10 g, 20 g, or 40 g dose lactose hydrogen breath test (LHBT) in a randomized, double-blinded, controlled trial. The lactase gene promoter region was sequenced. Breath samples and symptoms were acquired at baseline and every 15 min for 3 h (13 measurements). The detection rates of lactose malabsorption (LM) and lactose intolerance (LI) for a 4SLHBT that acquired four measurements at 0, 90, 120, and 180 min from the same data set were compared with the results of standard LHBT. Sixty IBS-D patients and 60 HVs were studied. The genotype in all participants was C/C-13910. LM and LI detection rates increased with lactose dose from 10 g, 20 g to 40 g in both groups (P < 0.001). 4SLHBT showed excellent diagnostic concordance with standard LHBT (97%-100%, Kappa​​ 0.815-0.942) with high sensitivity (90%-100%) and specificity (100%) at all three lactose doses in both groups. Reducing the number of measurements from 13 to 4 samples did not significantly impact on the accuracy of LHBT in health and IBS-D. 4SLHBT is a valid test for assessment of LM and LI in clinical practice.

  7. Evaluation of the performance of the reduced local lymph node assay for skin sensitization testing.

    PubMed

    Ezendam, Janine; Muller, Andre; Hakkert, Betty C; van Loveren, Henk

    2013-06-01

    The local lymph node assay (LLNA) is the preferred method for classification of sensitizers within REACH. To reduce the number of mice for the identification of sensitizers the reduced LLNA was proposed, which uses only the high dose group of the LLNA. To evaluate the performance of this method for classification, LLNA data from REACH registrations were used and classification based on all dose groups was compared to classification based on the high dose group. We confirmed previous examinations of the reduced LLNA showing that this method is less sensitive compared to the LLNA. The reduced LLNA misclassified 3.3% of the sensitizers identified in the LLNA and misclassification occurred in all potency classes and that there was no clear association with irritant properties. It is therefore not possible to predict beforehand which substances might be misclassified. Another limitation of the reduced LLNA is that skin sensitizing potency cannot be assessed. For these reasons, it is not recommended to use the reduced LLNA as a stand-alone assay for skin sensitization testing within REACH. In the future, the reduced LLNA might be of added value in a weight of evidence approach to confirm negative results obtained with non-animal approaches. Copyright © 2013 Elsevier Inc. All rights reserved.

  8. The use of different concentrations of betaine as a reducing irritation agent in soaps monitored visually and non-invasively.

    PubMed

    Nicander, Ingrid; Aberg, Peter; Ollmar, Stig

    2003-02-01

    Products containing detergents can damage the skin and give rise to irritant contact dermatitis. Therefore, attempts have been made to find less irritating detergents as well as substances decreasing undesired side-effects of detergents, and a novel approach is offered by betaine. The aim of the study has been to determine the irritating properties of some liquid soaps for personal hygiene and to map the effect of different concentrations of betaine using electrical impedance, trans-epidermal water loss and visual inspection. Twenty-eight healthy subjects were patch tested with different commercial soaps with and without betaine and sodium lauryl sulphate on both volar forearms for 24 h. A site with distilled water and an unoccluded area were used as references. Responses of the skin reactions were evaluated by visual inspection and by measuring trans-epidermal water loss and electrical impedance before application and 24 h after removal of the chambers. Significant skin reactions were found for all soaps tested but the soaps containing betaine were the least irritating. However, the skin irritation did not decrease with increasing concentrations of betaine in the tested range. On the whole the differences between the products were not large. The non-invasive methods used were more sensitive than visual assessment for evaluation of invisible or barely visible skin responses. Copyright Blackwell Munksgaard 2003

  9. Development of methods for skin barrier peeling tests.

    PubMed

    Omura, Yuko; Kazuharu, Seki; Kenji, Oishi

    2006-01-01

    We sought to develop a more effective method to evaluate the adhesive properties of skin barriers. The experimental design used was based on 3 principles: partial control, randomization, and repetition. Using these principles, the 180-degree peeling tests were conducted as specified in a standardized methodology (JIS Z0297) to the extent possible. However, the use of a stainless steel plate as a proxy for skin barrier application may result in the stretching and breaking of the skin barrier, making it impossible to obtain suitable measurements. Tests were conducted in constant temperature/ humidity chambers using a Tensilon Automatic Elongation Tester, where a sample was fixed on the side of a sample immobilization device, a sturdy metal (aluminum) box from which the air in the box was drawn off with a vacuum pump. A fluorocarbon polymer film was applied to the adhesive surface of a sample skin barrier. The film was peeled off in the volte-face (180-degree) direction in order to measure adhesive strengths. The films exhibit such properties as (a) ease of removal from the adhesive surface, (b) no resistance to a 180-degree fold back due to the thinness and flexibility of the material, and (c) tolerance of elongation. The adhesive properties of skin barriers were measured by peeling the fluorocarbon polymers in a 180-degree direction. Twelve specimen skin barrier products were selected for measurement, providing results with satisfactory reproducibility. Results based on the conventional stainless steel plate-based testing method acted as a control. The newly developed testing method enables chronological measurement results for skin barriers applied to fluorocarbon polymer films after 24 hours, 48 hours, and longer period.

  10. A new cell-based method for assessing the eye irritation potential of chemicals: an alternative to the Draize test.

    PubMed

    Cho, Sun-A; An, Susun; Lee, Eunyoung; Shin, Kyeho; Cho, Jun-Cheol; Lee, Tae Ryong

    2012-07-20

    Using a human corneal cell line (HCE-T cells) and 2 evaluation criteria, we developed a new alternative method to assess the eye irritation potential of chemicals. We exposed HCE-T cells to different concentrations of 38 chemicals for 1h and measured relative cell viability (RCV) as an endpoint at each concentration. Using the RCV values, we calculated the RCV50. We also exposed HCE-T cells to 3 fixed concentrations of the 38 chemicals (5%, 0.5%, and 0.05%) for 1h and measured the RCV at each concentration. Using the RCV values at 5%, 0.5%, and 0.05%, we developed a new criterion for eye irritation potential (total eye irritation score, TEIS) and estimated the ocular irritancy. We then assessed the correlation of the results of RCV50 and TEIS with those of the Draize rabbit eye irritation. Both the RCV50 and TEIS results exhibited good positive correlations (sensitivity: 80.77%, specificity: 83.33%, and accuracy: 81.58% for TEIS; sensitivity: 73.08-76.92%, specificity: 75.00%, and accuracy: 73.68-76.32% for RCV50). We conclude that the new in vitro model using HCE-T cells is a good alternative evaluation model for the prediction of the eye irritation potential of chemicals. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  11. Improved wheal detection from skin prick test images

    NASA Astrophysics Data System (ADS)

    Bulan, Orhan

    2014-03-01

    Skin prick test is a commonly used method for diagnosis of allergic diseases (e.g., pollen allergy, food allergy, etc.) in allergy clinics. The results of this test are erythema and wheal provoked on the skin where the test is applied. The sensitivity of the patient against a specific allergen is determined by the physical size of the wheal, which can be estimated from images captured by digital cameras. Accurate wheal detection from these images is an important step for precise estimation of wheal size. In this paper, we propose a method for improved wheal detection on prick test images captured by digital cameras. Our method operates by first localizing the test region by detecting calibration marks drawn on the skin. The luminance variation across the localized region is eliminated by applying a color transformation from RGB to YCbCr and discarding the luminance channel. We enhance the contrast of the captured images for the purpose of wheal detection by performing principal component analysis on the blue-difference (Cb) and red-difference (Cr) color channels. We finally, perform morphological operations on the contrast enhanced image to detect the wheal on the image plane. Our experiments performed on images acquired from 36 different patients show the efficiency of the proposed method for wheal detection from skin prick test images captured in an uncontrolled environment.

  12. Allergic reactions during allergy skin testing with food allergens.

    PubMed

    Pitsios, C; Dimitriou, A; Kontou-Fili, K

    2009-08-01

    Skin testing is a reliable and safe way to diagnose IgE-mediated allergies, with rare side-effects. Two cases of systemic allergic reactions during skin testing to food allergens are hereby reported. A 28-year-old male reported allergic reactions, mild to moderate in severity, each time he tasted fish in the frame of his professional duties. During SPT and prick-to-prick to raw and cooked fishes, he presented urticaria and tachycardia. A 59-year-old male had a long history of urticaria-angioedema and asthma attacks, following the consumption of mammalian meat. He was skin-tested to various meats and during the 5 last minutes of the test he developed generalized urticaria, allergic rhinitis and conjunctivitis. They were both advised to completely avoid the relative allergens. In conclusion, skin testing, particularly prick-to-prick, may cause anaphylaxis. Tests should be performed only by physicians with proper training in allergy, experienced in treating promptly and properly episodes of anaphylaxis.

  13. The local lymph node assay and skin sensitization testing.

    PubMed

    Kimber, Ian; Dearman, Rebecca J

    2010-01-01

    The mouse local lymph node assay (LLNA) is a method for the identification and characterization of skin sensitization hazards. In this context the method can be used both to identify contact allergens, and also determine the relative skin sensitizing potency as a basis for derivation of effective risk assessments.The assay is based on measurement of proliferative responses by draining lymph node cells induced following topical exposure of mice to test chemicals. Such responses are known to be causally and quantitatively associated with the acquisition of skin sensitization and therefore provide a relevant marker for characterization of contact allergic potential.The LLNA has been the subject of exhaustive evaluation and validation exercises and has been assigned Organization for Economic Cooperation and Development (OECD) test guideline 429. Herein we describe the conduct and interpretation of the LLNA.

  14. Cleansing lotion containing tamarind fruit pulp extract. II. Study of cumulative irritation effects in human.

    PubMed

    Maenthaisong, Ratree; Viyoch, Jarupa; Chaiyakunapruk, Nathorn; Warnnissorn, Prateep

    2007-09-01

    Cleansing lotion containing extract of tamarind fruit pulp was developed to provide skin a lighter effect. Skin irritation may occur due to keratolytic effect of alpha-hydroxyl acids (AHA) in the tamarind fruit pulp extract. To assess the cumulative irritation effect of cleansing lotion containing tamarind fruit extract with 2% (w/w) tartaric acid on human skin compared with placebo product and de-ionized water. The study design was a single-blinded, randomized side of arm, and controlled study. Three samples, including test product, placebo product, and de-ionized water, were repeatedly applied on the inner forearm of 15 healthy females (aged 28.3 +/- 3.1 years) for 30 min daily for 5 days under semi-occlusive patch. Skin irritation was measured by using visual scoring and instruments such as Tewameter and Mexameter. All measurements were done before application of samples every day from day 1 until day 5. Final measurements were done after the last application for 3 days (day 8). The results obtained from the visual scoring scale indicated no irritation signs and symptoms of test product. Mean differences of transepidermal water loss and erythema values between test product and de-ionized water and between test and placebo products were not statistically significant (P > 0.05). These findings indicate a preliminary safety evidence of our developed cleansing lotion containing the natural AHAs and can be used as cumulative evidence for supporting the future home use study of this product in human.

  15. Development and pilot testing of an integrated, web-based self-management program for irritable bowel syndrome (IBS).

    PubMed

    Dorn, S D; Palsson, O S; Woldeghebriel, M; Fowler, B; McCoy, R; Weinberger, M; Drossman, D A

    2015-01-01

    Although essential, many medical practices are unable to adequately support irritable bowel syndrome (IBS) patient self-management. Web-based programs can help overcome these barriers. We developed, assessed, and refined an integrated IBS self-management program (IBS Self-care). We then conducted a 12-week pilot test to assess program utilization, evaluate its association with patients' self-efficacy and quality of life, and collect qualitative feedback to improve the program. 40 subjects with generally mild IBS were recruited via the Internet to participate in a 12-week pilot study. Subjects found the website easy to use (93%) and personally relevant (95%), and 90% would recommend it to a friend. Self-rated IBS knowledge increased from an average of 47.1 on a 100-point VAS scale (SD 22.1) at baseline to 77.4 (SD: 12.4) at week 12 (p < 0.0001). There were no significant changes in patient self-efficacy (Patient Activation Measure) or quality of life (IBS -Quality of Life Scale). The IBS Self-Care program was well received by users who after 12 weeks reported improved knowledge about IBS, but no significant changes in self-efficacy or quality of life. If applied to the right population, this low cost solution can overcome some of the deficiencies of medical care and empower individuals to better manage their own IBS. © 2014 John Wiley & Sons Ltd.

  16. Reconstituted human corneal epithelium: a new alternative to the Draize eye test for the assessment of the eye irritation potential of chemicals and cosmetic products.

    PubMed

    Doucet, O; Lanvin, M; Thillou, C; Linossier, C; Pupat, C; Merlin, B; Zastrow, L

    2006-06-01

    The aim of this study was to evaluate the interest of a new three-dimensional epithelial model cultivated from human corneal cells to replace animal testing in the assessment of eye tolerance. To this end, 65 formulated cosmetic products and 36 chemicals were tested by means of this in vitro model using a simplified toxicokinetic approach. The chemicals were selected from the ECETOC data bank and the EC/HO International validation study list. Very satisfactory results were obtained in terms of concordance with the Draize test data for the formulated cosmetic products. Moreover, the response of the corneal model appeared predictive of human ocular response clinically observed by ophthalmologists. The in vitro scores for the chemicals tested strongly correlated with their respective scores in vivo. For all the compounds tested, the response of the corneal model to irritants was similar regardless of their chemical structure, suggesting a good robustness of the prediction model proposed. We concluded that this new three-dimensional epithelial model, developed from human corneal cells, could be promising for the prediction of eye irritation induced by chemicals and complex formulated products, and that these two types of materials should be tested using a similar protocol. A simple shortening of the exposure period was required for the chemicals assumed to be more aggressively irritant to the epithelial tissues than the cosmetic formulae.

  17. The skin sensitization potential of four alkylalkanolamines.

    PubMed

    Leung, H W; Blaszcak, D L

    1998-04-01

    The skin sensitization potential of 4 alkylalkanolamines (N-methylethanolamine, N,N-dimethylethanolamine, N-methyldiethanolamine and N,N-diethylethanolamine), was evaluated in a guinea pig maximation procedure by the method of Magnusson and Kligman. While all 4 alkylalkanolamines tested were irritating to the guinea pig skin, only N-methylethanolamine showed potential to induce allergic contact dermatitis. None of the remaining 3 alkylalkanolamines exhibited clear skin responses suggestive of sensitization.

  18. Functional testing of topical skin formulations using an optimised ex vivo skin organ culture model.

    PubMed

    Sidgwick, G P; McGeorge, D; Bayat, A

    2016-07-01

    A number of equivalent-skin models are available for investigation of the ex vivo effect of topical application of drugs and cosmaceuticals onto skin, however many have their drawbacks. With the March 2013 ban on animal models for cosmetic testing of products or ingredients for sale in the EU, their utility for testing toxicity and effect on skin becomes more relevant. The aim of this study was to demonstrate proof of principle that altered expression of key gene and protein markers could be quantified in an optimised whole tissue biopsy culture model. Topical formulations containing green tea catechins (GTC) were investigated in a skin biopsy culture model (n = 11). Punch biopsies were harvested at 3, 7 and 10 days, and analysed using qRT-PCR, histology and HPLC to determine gene and protein expression, and transdermal delivery of compounds of interest. Reduced gene expression of α-SMA, fibronectin, mast cell tryptase, mast cell chymase, TGF-β1, CTGF and PAI-1 was observed after 7 and 10 days compared with treated controls (p < 0.05). Histological analysis indicated a reduction in mast cell tryptase and chymase positive cell numbers in treated biopsies compared with untreated controls at day 7 and day 10 (p < 0.05). Determination of transdermal uptake indicated that GTCs were detected in the biopsies. This model could be adapted to study a range of different topical formulations in both normal and diseased skin, negating the requirement for animal models in this context, prior to study in a clinical trial environment.

  19. Winter season, frequent hand washing, and irritant patch test reactions to detergents are associated with hand dermatitis in health care workers.

    PubMed

    Callahan, Adrienne; Baron, Elma; Fekedulegn, Desta; Kashon, Michael; Yucesoy, Berran; Johnson, Victor J; Domingo, Diana Santo; Kirkland, Brent; Luster, Michael I; Nedorost, Susan

    2013-01-01

    Irritant hand dermatitis (IHD) is common in health care workers. We studied endogenous irritant contact dermatitis threshold by patch testing and exogenous factors such as season and hand washing for their association with IHD in health care workers. Irritant patch testing with sodium lauryl sulfate (SLS), sodium hydroxide, and benzalkonium chloride at varying concentrations was measured in 113 health care workers. Examination for hand dermatitis occurred at 1-month intervals for a period of 6 months in the Midwestern United States. Positive patch testing to low-concentration SLS was associated with IHD (P = 0.0310) after adjusting for age, sex, ethnicity, season, history of childhood flexural dermatitis, mean indoor relative humidity, and glove and hand sanitizer usage. Subjects with a positive patch test to SLS were 78% more likely to have occurrence of IHD (incidence rate ratio [IRR] = 1.78; 95% confidence interval [CI], 0.92-3.45). Hand washing frequency (≥10 times a day; IRR = 1.55; 95% CI, 1.01-2.39) and cold season (IRR = 2.76; 95% CI, 1.35-5.65) were associated with IHD. No association was found between history of childhood flexural dermatitis and IHD in this population. Both genetic and environmental factors are important in the etiology of IHD and should be considered in designing strategies to protect, educate, and treat susceptible individuals.

  20. Sporotrichin Skin Test for the Diagnosis of Sporotrichosis.

    PubMed

    Bonifaz, Alexandro; Toriello, Conchita; Araiza, Javier; Ramírez-Soto, Max C; Tirado-Sánchez, Andrés

    2018-05-09

    Sporotrichosis is the most common implantation mycosis caused by several species of the Sporothrix schenckii complex. The gold standard for diagnosis is concerned with the isolation of the fungus; although, fresh examinations, staining, and biopsies are also helpful for this purpose. The sporotrichin is an antigenic complex comprised of a peptide-rhamnomannan, which is relevant with respect to pathogenic fungi; it is primarily used for serological and skin testing. We present a study regarding the use of sporotrichin as a diagnostic aid for cutaneous sporotrichosis. Furthermore, 138 cases with suspicion of sporotrichosis were included, 55 of which were proven through cultures. Moreover, out of these 55 cases, 52 (94.5%) tested positive for sporotrichin, while the negative cases corresponded to the disseminated cutaneous forms. We observed a sensitivity of 94.5% and a specificity of 95.2%. We consider that the use of sporotrichin as a skin test helps us as an auxiliary diagnosis before a positive sample culture.

  1. Determination of rifaximin treatment period according to lactulose breath test values in nonconstipated irritable bowel syndrome subjects.

    PubMed

    Bae, Suhyun; Lee, Kwang Jae; Kim, Young-Sang; Kim, Kyu-Nam

    2015-06-01

    Small intestinal bacterial overgrowth (SIBO) can partly explain irritable bowel syndrome (IBS), and rifaximin has been observed to improve abdominal symptoms in nonconstipated IBS patients. However, there are few reports on the association of the rifaximin treatment periods with the results of a lactulose breath test (LBT). Therefore, we performed a retrospective review of patient charts to investigate the relation between the rifaximin treatment periods with LBT results in nonconstipated IBS patients. We also evaluated the time to achieve a symptomatic improvement in the IBS patients as compared to the changes in the LBT. We reviewed the charts for patients who showed IBS symptoms with documented positive results for LBT during their initial visit and who had a follow-up LBT after treatment with rifaximin. The LBT values were compared to the subjects' symptom scores. A total of 102 subjects had a follow-up LBT to assess LBT normalization. The subjects were divided into groups according to treatment periods of 4 weeks (n = 36), 8 weeks (n = 43), and 12 weeks (n = 23). The groups with a longer treatment exhibited an increase in the hydrogen gas value at 90 min and its sum during 90 min at the initial LBT. There were significant differences in hydrogen gas value at 90 min and in its sum during 90 min at the initial LBT between the groups treated for 4 and 12 weeks. The most significant treatment response was observed during the first 4 weeks for all treatment groups. Symptomatic improvement occurred earlier than LBT normalization in the treatment period over 4 weeks. The results indicate that different rifaximin treatment periods are needed in accordance with LBT levels to effectively eradicate SIBO.

  2. Anaphylaxis during skin testing with food allergens in children.

    PubMed

    Pitsios, Constantinos; Dimitriou, Anastasia; Stefanaki, Efthalia C; Kontou-Fili, Kalliopi

    2010-05-01

    Skin testing is the diagnostic cornerstone for allergies and is considered extremely safe. It is usually performed with the prick and the prick-to-prick method. The aim of this study is to report the first two pediatric cases of systemic allergic reactions during skin prick tests (SPT) with commercial food allergens. Both patients had a history of fish allergy. A 5-year-old girl, with a history of atopic dermatitis and asthma, reported an episode of urticaria and angioedema due to ingestion of fish, which had occurred 2 years before consultation. Ten minutes after having completed SPT to fish extracts, which had resulted positive, she suffered from generalized pruritus, nausea, stomach pain, and loss of consciousness. A 9-year-old boy, with a history of asthma and two episodes of acute urticaria and angioedema upon eating fish during infancy, reported a recent episode of oropharyngeal pruritus after tasting salmon. He was evaluated for fish allergy with SPT but developed conjunctivitis and acute urticaria during the first 10 min of the test. Anaphylaxis appears to be a rare side effect of skin testing in pediatric patients. Children with a history of asthma and atopic dermatitis are more likely to react.

  3. Comparison of intradermal dilutional testing, skin prick testing, and modified quantitative testing for common allergens.

    PubMed

    Peltier, Jacques; Ryan, Matthew W

    2007-08-01

    To compare and correlate wheal size using the Multi-Test II applicator with the endpoint obtained by intradermal dilutional testing (IDT) for 5 common allergens. To examine the safety of modified quantitative testing (MQT) for determining immunotherapy starting doses. Prospective comparative clinical study. A total of 134 subjects were simultaneously skin tested for immediate hypersensitivity using the Multi-Test II device and IDT. There was a 77% concordance between results from IDT and results from MQT. When there was a difference, MQT predicted a safer endpoint for starting immunotherapy in all but 2 cases. Wheal size by SPT is predictive of endpoint by IDT. MQT is nearly as effective as formal IDT in determining endpoint. Modified quantitative testing appears to be a safe alternative to IDT for determining starting doses for immunotherapy.

  4. Penicillin skin testing: potential implications for antimicrobial stewardship.

    PubMed

    Unger, Nathan R; Gauthier, Timothy P; Cheung, Linda W

    2013-08-01

    As the progression of multidrug-resistant organisms and lack of novel antibiotics move us closer toward a potential postantibiotic era, it is paramount to preserve the longevity of current therapeutic agents. Moreover, novel interventions for antimicrobial stewardship programs are integral to combating antimicrobial resistance worldwide. One unique method that may decrease the use of second-line antibiotics (e.g., fluoroquinolones, vancomycin) while facilitating access to a preferred β-lactam regimen in numerous health care settings is a penicillin skin test. Provided that up to 10% of patients have a reported penicillin allergy, of whom ~10% have true IgE-mediated hypersensitivity, significant potential exists to utilize a penicillin skin test to safely identify those who may receive penicillin or a β-lactam antibiotic. In this article, we provide information on the background, associated costs, currently available literature, pharmacists' role, antimicrobial stewardship implications, potential barriers, and misconceptions, as well as future directions associated with the penicillin skin test. © 2013 Pharmacotherapy Publications, Inc.

  5. Diagnostic performance of the "MESACUP anti-Skin profile TEST".

    PubMed

    Horváth, Orsolya N; Varga, Rita; Kaneda, Makoto; Schmidt, Enno; Ruzicka, Thomas; Sárdy, Miklós

    2016-01-01

    The "MESACUP anti-Skin profile TEST" is a new, commercially available ELISA kit to detect circulating IgG autoantibodies against desmoglein 1, desmoglein 3, BP180, BP230, and type VII collagen, both simultaneously and more rapidly than previous assays. The aim of this study was to evaluate the diagnostic accuracy of this kit for the diagnosis of pemphigus foliaceus, pemphigus vulgaris, bullous pemphigoid and epidermolysis bullosa acquisita. Dual-centre retrospective study in which 138 patients with autoimmune blistering diseases were compared to 40 controls Using the MESACUP anti-Skin profile TEST, both sensitivities and specificities for desmoglein 1, desmoglein 3, BP180, BP230, and type VII collagen autoantibodies were similar to those obtained using previous, specific ELISA systems and 88% of the results were concordant without any significant difference. The MESACUP anti-Skin profile TEST had a similar performance to previously produced ELISA systems. The novel kit can be used for rapid diagnosis of most common autoimmune blistering diseases and is especially suitable for identifying overlapping disorders.

  6. [The tuberculin skin test in BCG-vaccinated individualse].

    PubMed

    Miret Cuadras, P; Pina Gutiérrez, J M

    1998-10-01

    The aim of this study was to evaluate the tuberculin skin test in individuals vaccinated with bacillus Calmette-Guérin (BCG) using 2 IU of RT-23. One hundred ninety-six individuals aged 22-40 years-old who had been vaccinated with BCG between 1965 and 1974 were enrolled along with 375 non-vaccinated individuals of the same age and with similar level of risk of infection. The positive predictive value of the test was assessed for three levels of response as indicated by areas of thickening in three diameters: 5, 10 and 15 mm. Vaccinated individuals with negative results were given a second skin test 7 days later to detect a booster effect. Positive diameters 5 mm were observed in 66% of the vaccinated individuals and 24% of the non-vaccinated subjects. Positive diameters 10 mm were observed in 51% of the vaccinated individuals and 19% of the non vaccinated ones. Positive diameters 15 mm were observed in 29% of the vaccinated subjects and in 13% of the non vaccinated ones. The differences were significant for all diameters. The positive predictive value of the test was 36.4% for a diameter 5 mm, 37.6% for diameter 10 mm and 44.8% for diameter 15 mm. The booster effect was detected in 25.8% of the vaccinated individuals who had tested negative at first. In vaccinated individuals, no guidelines can be established to guarantee that a positive reaction is due to infection by Mycobacterium tuberculosis infection, although the likelihood of infection (increased positive predictive value) increases with diameter. It is also impossible to fix a time limit. A second skin test is needed to detect a booster effect in all vaccinated individuals whose first test is negative.

  7. A comparison of skin prick tests, intradermal skin tests, and specific IgE in the diagnosis of mouse allergy.

    PubMed

    Sharma, Hemant P; Wood, Robert A; Bravo, Andrea R; Matsui, Elizabeth C

    2008-04-01

    Mouse sensitization is assessed by using skin testing and serum levels of mouse allergen-specific IgE (m-IgE). However, it is unknown whether a positive skin test response or m-IgE result accurately identifies those with clinically relevant mouse sensitization. We sought to compare skin testing and m-IgE measurement in the diagnosis of mouse allergy. Sixty-nine mouse laboratory workers underwent skin prick tests (SPTs), intradermal tests (IDTs), and serum IgE measurements to mouse allergen, followed by nasal challenge to increasing concentrations of mouse allergen. Challenge response was assessed by nasal symptom score. Thirty-eight women and 31 men with a mean age of 30 years were studied. Forty-nine workers reported mouse-related symptoms, of whom 10 had positive m-IgE results and 12 had positive SPT responses. Fifteen had negative SPT responses but positive IDT responses. Positive nasal challenges were observed in 70% of workers with positive m-IgE results, 83% of workers with positive SPT responses, 33% of workers with negative SPT responses/positive IDT responses, and 0% of workers with negative IDT responses. SPTs performed best, having the highest positive and negative predictive values. Among participants with a positive challenge result, those with a positive SPT response or m-IgE result had a significantly lower challenge threshold than those with a positive IDT response (P = .01). Workers with a positive challenge result were more likely to have an increase in nasal eosinophilia after the challenge compared with those with a negative challenge result (P = .03). SPTs perform best in discriminating patients with and without mouse allergy. Mouse-specific IgE and IDTs appear to be less useful than SPTs in the diagnosis of mouse allergy.

  8. Herbal supplements and skin testing: the lack of effect of commonly used herbal supplements on histamine skin prick testing.

    PubMed

    More, D R; Napoli, D C; Hagan, L L

    2003-06-01

    The use of herbal supplements is common, yet little is known about their pharmacologic properties. The purpose of this study was to assess the effects of 23 commonly used herbal supplements on histamine skin prick testing (SPT). Fifteen healthy volunteers participated in a double-blind, placebo-controlled, single-dose, crossover study. Wheal and flare responses to SPT with histamine phosphate (1 mg/ml) were measured before and 4 h after administration of each of the 23 popular herbal supplements, fexofenadine (60 mg) and placebo. Wheal and flare areas were recorded with tracings performed 10 min after the prick test and measured with a PC-digitizer using stereometric software. Fexofenadine significantly suppressed the wheal (P < 0.001) and flare (P = 0.02) areas compared with placebo. None of the herbal supplements caused significant suppression of the wheal and flare areas compared with placebo (P > 0.10). When taken in single-doses, the popular herbal supplements tested did not significantly affect the histamine skin response. Therefore, it seems unnecessary for clinicians to ask patients to discontinue these herbal supplements prior to allergy skin testing.

  9. Screening for eye irritancy using cultured HeLa cells.

    PubMed

    Selling, J; Ekwall, B

    1985-01-01

    To investigate whether toxicity tests on HeLa cells were predictive of eye irritancy, 18 compounds of known eye irritancy and in vitro cytotoxicity were tested on HeLa cells in the MIT-24 system. The results correlated well with eye irritancy as determined by the Draize test in rabbits for 16 of the test substances, but failed to detect the high eye irritancy of 1-heptanol and allyl alcohol, both of which were cytotoxic in other cellular systems.

  10. Apparatus for testing skin samples or the like

    DOEpatents

    Holland, J.M.

    1982-08-31

    An apparatus for testing the permeability of living skin samples has a flat base with a plurality of sample-holding cavities formed in its upper surface, the samples being placed in counterbores in the cavities with the epidermis uppermost. O-rings of Teflon washers are respectively placed on the samples and a flat cover is connected to the base to press the rings against the upper surfaces of the samples. Media to maintain tissue viability and recovery of metabolites is introduced into the lower portion of the sample-holding cavities through passages in the base. Test materials are introduced through holes in the cover plate after assembly of the chamber.

  11. Benzalkonium chloride neutralizes the irritant effect of sodium dodecyl sulfate.

    PubMed

    McFadden, J P; Holloway, D B; Whittle, E G; Basketter, D A

    2000-11-01

    When benzalkonium chloride (BKC), a cationic surfactant, is added to sodium dodecyl sulfate (SDS), an anionic surfactant, and used in patch testing, on the basis of their known physicochemical interaction, it is possible to predict that there will be a tendency towards a reduction in the expected irritant response when compared to SDS alone. The aim of this study was to investigate whether BKC could reduce the irritant response to SDS when applied after the SDS exposure. 54 non-atopic adult volunteers were recruited for the study. 20% SDS was applied for 2 h under occlusion. 1% BKC was then applied to the same site. Various controls, including SDS application followed by water for 2 h, were included. The irritant reaction was assessed at 24 h and 48 h. 40 of the 54 subjects had some reaction when SDS was applied for 2 h followed by either benzalkonium chloride or water control under occlusion. In comparison to water control, where BKC was applied after SDS, 20 of the 40 responders had a weaker reaction but only 4 had a stronger response. This study shows that BKC applied to skin exposed to SDS attenuates the resulting irritant reaction.

  12. The CTFA Evaluation of Alternatives Program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase III) surfactant-based formulations.

    PubMed

    Gettings, S D; Lordo, R A; Hintze, K L; Bagley, D M; Casterton, P L; Chudkowski, M; Curren, R D; Demetrulias, J L; Dipasquale, L C; Earl, L K; Feder, P I; Galli, C L; Glaza, S M; Gordon, V C; Janus, J; Kurtz, P J; Marenus, K D; Moral, J; Pape, W J; Renskers, K J; Rheins, L A; Roddy, M T; Rozen, M G; Tedeschi, J P; Zyracki, J

    1996-01-01

    The CTFA Evaluation of Alternatives Program is an evaluation of the relationship between data from the Draize primary eye irritation test and comparable data from a selection of promising in vitro eye irritation tests. In Phase III, data from the Draize test and 41 in vitro endpoints on 25 representative surfactant-based personal care formulations were compared. As in Phase I and Phase II, regression modelling of the relationship between maximum average Draize score (MAS) and in vitro endpoint was the primary approach adopted for evaluating in vitro assay performance. The degree of confidence in prediction of MAS for a given in vitro endpoint is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curve. Prediction intervals reflect not only the error attributed to the model but also the material-specific components of variation in both the Draize and the in vitro assays. Among the in vitro assays selected for regression modeling in Phase III, the relationship between MAS and in vitro score was relatively well defined. The prediction bounds on MAS were most narrow for materials at the lower or upper end of the effective irritation range (MAS = 0-45), where variability in MAS was smallest. This, the confidence with which the MAS of surfactant-based formulations is predicted is greatest when MAS approaches zero or when MAS approaches 45 (no comment is made on prediction of MAS > 45 since extrapolation beyond the range of observed data is not possible). No single in vitro endpoint was found to exhibit relative superiority with regard to prediction of MAS. Variability associated with Draize test outcome (e.g. in MAS values) must be considered in any future comparisons of in vivo and in vitro test results if the purpose is to predict in vivo response using in vitro data.

  13. Short Time Exposure (STE) test in conjunction with Bovine Corneal Opacity and Permeability (BCOP) assay including histopathology to evaluate correspondence with the Globally Harmonized System (GHS) eye irritation classification of textile dyes.

    PubMed

    Oliveira, Gisele Augusto Rodrigues; Ducas, Rafael do Nascimento; Teixeira, Gabriel Campos; Batista, Aline Carvalho; Oliveira, Danielle Palma; Valadares, Marize Campos

    2015-09-01

    Eye irritation evaluation is mandatory for predicting health risks in consumers exposed to textile dyes. The two dyes, Reactive Orange 16 (RO16) and Reactive Green 19 (RG19) are classified as Category 2A (irritating to eyes) based on the UN Globally Harmonized System for classification (UN GHS), according to the Draize test. On the other hand, animal welfare considerations and the enforcement of a new regulation in the EU are drawing much attention in reducing or replacing animal experiments with alternative methods. This study evaluated the eye irritation of the two dyes RO16 and RG19 by combining the Short Time Exposure (STE) and the Bovine Corneal Opacity and Permeability (BCOP) assays and then comparing them with in vivo data from the GHS classification. The STE test (first level screening) categorized both dyes as GHS Category 1 (severe irritant). In the BCOP, dye RG19 was also classified as GHS Category 1 while dye RO16 was classified as GHS no prediction can be made. Both dyes caused damage to the corneal tissue as confirmed by histopathological analysis. Our findings demonstrated that the STE test did not contribute to arriving at a better conclusion about the eye irritation potential of the dyes when used in conjunction with the BCOP test. Adding the histopathology to the BCOP test could be an appropriate tool for a more meaningful prediction of the eye irritation potential of dyes. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Occupational allergic and irritant contact dermatitis in workers exposed to polyurethane foam.

    PubMed

    Kieć-Świerczyńska, Marta; Swierczyńska-Machura, Dominika; Chomiczewska-Skóra, Dorota; Nowakowska-Świrta, Ewa; Kręcisz, Beata

    2014-04-01

    To evaluate sensitization to chemicals present in work environment after an outbreak of contact dermatitis in workers of vehicle equipment factory, exposed to polyurethane foam, based on 4,4'-diphenylmethane diisocyanate (MDI). From among 300 employees, 21 individuals reporting work-related skin and/or respiratory tract symptoms underwent clinical examination, patch testing, skin prick tests, spirometry and MDI sIgE measurement in serum. Patch tests included isocyanates series, selected rubber additives, metals, fragrances, preservatives, and an antiadhesive agent. Clinical examination revealed current eczema in the area of hands and/or forearms in 10 workers. Positive patch test reactions were found in 10 individuals, the most frequent to diaminodiphenylmethane and 4-phenylenediamine (7 persons). Reactions to an antiadhesive agent were assessed as irritant (5 workers). Except for sensitization to common aeroallergens, no significant abnormalities were found in the remaining tests. Occupational allergic contact dermatitis was diagnosed in 7 workers, irritant contact dermatitis in 10 and coexisiting allergic and irritant contact dermatitis in 3 workers. In workers manufacturing products from polyurethane foam, attention should be paid to the risk of developing contact dermatitis. Skin problems in our study group were attributable probably to insufficient protection of the skin.

  15. Cutaneous irritancy of an ibuprofen medicated plaster in healthy volunteers.

    PubMed

    Maganji, Manisha; Connolly, Mark P; Bhatt, Aomesh

    2018-04-01

    To assess the irritation and contact sensitization potential of a 200 mg ibuprofen medicated plaster. This double-blind, phase-1 placebo controlled study had two phases; the induction phase to evaluate the irritant potential of continuous application of the plaster, and the challenge phase to assess contact sensitivity (allergy). The cumulative irritancy potential was evaluated using an adaptation of the Shelanski method. Healthy adults (≥18 years of age) (N = 210) were treated simultaneously with one ibuprofen medicated and one placebo plaster applied in a randomized fashion to either the left or right side of the lower back. During the induction phase, plasters were applied on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 and the final plaster removed on Day 22. At each scheduled visit plasters and applications sites were assessed for degree of adhesion and skin irritation (score of 1 = no irritation to 7 = strong reaction spreading beyond test sites), respectively. The challenge phase followed a two-week washout period. A plaster was applied on Day 36 for 48 h and assessment occurred on Days 38, 39, and 40. The mean cumulative irritation score during the induction phase was lower for the ibuprofen medicated plaster than the placebo plaster (0.32 vs. 1.23, respectively). Three (1.4%) subjects experience a dermal reaction of grade ≥3 for the ibuprofen medicated plaster compared with 27 (12.7%) for the placebo plaster. Following challenge with ibuprofen or placebo plasters, 12 subjects (6.2%) with the ibuprofen medicated plaster and four (2.2%) with the placebo plaster had skin reaction of assessment grade higher than the induction phase. One subject for the ibuprofen and two for the placebo plaster had reactions with grade >2. No subjects showed an increase in sensitization on Day 39 or 40 compared with Day 38. The findings indicate that the both the irritancy and contact sensitization of the ibuprofen medicated plaster is acceptable.

  16. Immunopathogenesis of fish allergy: identification of fish-allergic adults by skin test and radioallergosorbent test.

    PubMed

    Helbling, A; McCants, M L; Musmand, J J; Schwartz, H J; Lehrer, S B

    1996-07-01

    As the consumption of fish increases in the United States, the importance of allergic reactions to fish has become clear. Since most previous studies on fish allergy have focused on children reacting mainly to codfish, there is a need to investigate allergic reactions to other fish in adults. To identify fish-allergic adults, and to assess cross-reactivity among different species of fish by RAST inhibition. Thirty-nine individuals who reported fish allergy were selected for study; 32 (82%) were atopic as defined by two or more positive skin tests to common inhalant allergens and a history of allergic reactions and 33 (85%) experienced allergic symptoms within 30 minutes after ingesting fish. The most frequently reported symptoms were hives (69%), itching (69%), and wheezing/chest tightness (54%). Study subjects were skin tested with fish extracts and their sera assayed for IgE antibodies to different fish species. Thirty-six (92%) of the subjects tested had a positive skin test to at least one of 17 fish extracts tested; 9/35 (26%) reacted to all 17 extracts. Of the atopic (two or more positive skin tests to common inhalant allergens plus a personal and/or family history of allergy) and nonatopic fish-tolerant controls, 20/26 (77%) reacted by skin test to one or more fish extracts tested; the most prevalent positive reaction was to anchovy (73%). A significant correlation (P < .01) was observed between skin test reactivity of fish-allergic subjects to most fish extracts and fish RAST reactions. Radioallergosorbent inhibition testing demonstrated significant cross-reactivity among pollack, salmon, trout, and tuna; and between mackerel and anchovy. These results suggest that fish-allergic subjects may be clinically sensitive to more than one species of fish. Skin test reactivity to fish by itself is not an adequate criterion for the confirmation of clinically relevant fish allergy; consequently, fish-allergic subjects with positive skin tests to several fish species

  17. [Characteristics of allergic conjunctivitis with positive skin prick test].

    PubMed

    Yang, S; Jiang, Y; Jin, Y M; Zhang, J Y; Li, Y

    2017-09-11

    Objective: To observe the clinical characteristics of allergic conjunctivitis, and the correlations with skin prick test results. Methods: A retrospective study. Forty patients with positive skin prick test result were included. Patients underwent an ophthalmologic examination to identify their primary presenting signs and symptoms. The allergy types were divided into 5 groups. All dates were analyzed for the dependence, normality and homogeneity of variance. Chi-square test, Mann-Whitney U test, Kruskal-Wallis H test and Spearman correlation analysis were performed accordingly. Results: Among 40 patients, 18(45.0%) had a clinical diagnosis of seasonal allergic conjunctivitis, 14(35.0%) had perennial allergic conjunctivitis, 5(12.5%) had vernal keratoconjunctivitis, and 2(5.0%) had atopic keratoconjunctivits, and 1(2.5%) had giant papillary conjunctivitis. There was no significant difference in the number of symptoms and signs score among different types of allergic conjunctivitis, the score of itching and hyperemia had a positive relationship with the number of positive allergens ( r =0.74, P< 0.05. r =0.96, P< 0.05). The primary symptoms and signs are itching and hyperemia; dust and pollens are the most common allergens. The more positive result of the test of the allergen, the more symptoms and signs encountered in terms of severity. Conclusion: Seasonal allergic conjunctivitis was the most prevalent disorder, the most important clinical characteristics of allergic conjunctivitis are itching and conjunctival congestion, the main allergens are dust and pollens, patients may be sensitive to multiple allergens. (Chin J Ophthalmol, 2017, 53: 689-693) .

  18. Acute toxicity and primary irritancy of alkylalkanolamines.

    PubMed

    Ballantyne, B; Leung, H W

    1996-12-01

    The acute handling hazards of several alkylalkanolamines were determined by investigating their potential acute toxicity and primary irritancy. Materials studied were N-methylethanolamine (MEA), N, N, -dimethylethanolamine (DMEA), N, N, -dimethylisopropanolamine (DMIPA), N-methyldiethanolamine (MDEA), and tertbutyldiethanolamine (BDEA). All these alkylalkanolamines were of comparable acute peroral toxicity in the rat (LD50 range 1.48-2.83 ml/kg). By 24 h occluded epicutaneous contact in the rabbit, MEA, DMEA and DMIPA were of moderate acute percutaneous toxicity (LD50 range 1.13-2.0 ml/kg), MDEA was of slight acute percutaneous toxicity (LD50 male 9.85 ml/kg, female 10.90 ml/kg), and BDEA of intermediate toxicity (LD50 6.4 ml/kg). Due to differences in vapor pressure the acute vapor exposure toxicity of the alkylalkanolamines to rats varied; MEA, MDEA and BDEA were of a low order of acute toxicity, and DMIPA was moderately toxic with an LT50 of 3.2 h for a saturated vapor atmosphere exposure. A 4 h-LC50 (rat combined sex) of 1461 ppm was determined for DMEA. All alkylalkanolamines studied, except MDEA, were moderately to markedly irritating and caused variable degrees of skin corrosivity; MDEA caused only transient minor skin irritation. In accord with the skin irritancy results, the eye irritancy from 0.005 ml MEA, DMEA, DMIPA and BDEA was severe, and that from MDEA was slight. Exposure to these compounds has implications for occupational health procedures.

  19. Dietary cancer risk from conditional cancerogens in produce of livestock fed on species of spurge (Euphorbiaceae). II. Pathophysiological investigations in lactating goats fed on the skin irritant herb Euphorbia peplus and in their milk-raised kids.

    PubMed

    Nawito, M; Ahmed, Y F; Zayed, S M; Hecker, E

    1998-01-01

    Lactating goats were fed on aerial parts of the herb Euphorbia peplus L. admixed with their usual green fodder. During the experimental feeding period they showed symptoms of general poisoning. In necropsy the main toxic effects were seen in the heart, lung and liver. Histopathological examinations revealed that the primary toxic effects originated from degenerative changes in parenchymal and endothelial cells. Adverse symptoms in the liver and kidney were also reflected in an alteration of the levels of certain serum enzymes and of blood urea nitrogen. The milk of the goats fed on E. peplus, consumed by their young kids, caused poisoning and even death, with signs similar to those observed in the adult dams. These observations support the hypothesis that the poisoning observed in both milk-raised kids and mother goats is caused by diterpene ester type toxins present in the aerial parts of the herb contaminating the dams fodder. Generally, such skin irritant and hyperplasiogenic toxins are known to be highly active tumour promoters of skin and other organ, e.g. in mice. Lactating goats--as an important source of milk around the world--in a setting similar to that described, may provide a valid experimental etiological model for investigation of food polluted by tumour-promoting diterpene ester toxins.

  20. EPA Releases Draft Policy to Reduce Animal Testing for Skin Sensitization

    EPA Pesticide Factsheets

    The document, Draft Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing, describes the science behind the non-animal alternatives that can now be used to identify skin sensitization.

  1. Reprint of "CON4EI: Bovine Corneal Opacity and Permeability (BCOP) test for hazard identification and labelling of eye irritating chemicals".

    PubMed

    Verstraelen, Sandra; Maglennon, Gareth; Hollanders, Karen; Boonen, Francis; Adriaens, Els; Alépée, Nathalie; Drzewiecka, Agnieszka; Gruszka, Katarzyna; Kandarova, Helena; Willoughby, Jamin A; Guest, Robert; Schofield, Jane; Van Rompay, An R

    2018-06-01

    Assessment of ocular irritation potential is an international regulatory requirement in the safety evaluation of industrial and consumer products. None in vitro ocular irritation assays are capable of fully categorizing chemicals as stand-alone. Therefore, the CEFIC-LRI-AIMT6-VITO CON4EI consortium assessed the reliability of eight in vitro test methods and computational models as well as established a tiered-testing strategy. One of the selected assays was Bovine Corneal Opacity and Permeability (BCOP). In this project, the same corneas were used for measurement of opacity using the OP-KIT, the Laser Light-Based Opacitometer (LLBO) and for histopathological analysis. The results show that the accuracy of the BCOP OP-KIT in identifying Cat 1 chemicals was 73.8% while the accuracy was 86.3% for No Cat chemicals. BCOP OP-KIT false negative results were often related to an in vivo classification driven by conjunctival effects only. For the BCOP LLBO, the accuracy in identifying Cat 1 chemicals was 74.4% versus 88.8% for No Cat chemicals. The BCOP LLBO seems very promising for the identification of No Cat liquids but less so for the identification of solids. Histopathology as an additional endpoint to the BCOP test method does not reduce the false negative rate substantially for in vivo Cat 1 chemicals. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Oral antibiotic adverse reactions after penicillin skin testing: multi-year follow-up.

    PubMed

    Macy, E; Burchette, R J

    2002-12-01

    Long-term follow-up data on adverse drug reactions after oral antibiotic use in penicillin allergy history positive individuals with penicillin skin test done in advance of need are rare. Oral antibiotic associated adverse drug reactions in 83 penicillin skin test positive individuals were compared to a sex, age, and length of follow-up matched sample of 166 penicillin skin test negative individuals, all of whom had at least one post penicillin skin test oral antibiotic. The mean post penicillin skin test follow-up interval was 34.5 +/- 16.6 months. There were 1655 total oral antibiotic exposures. In penicillin skin test positive individuals, the adverse drug reaction rate was not significantly different with cephalosporin or non-beta-lactam use (P = 0.12). In penicillin skin test negative individuals the adverse drug reaction rate was significantly lower with cephalosporin vs. non-beta-lactam use (P = 0.005). Penicillin was safely used in penicillin skin test negative individuals. Overall cephalosporins caused fewer adverse drug reactions independent of penicillin skin test status (P = 0.005). Penicillin skin testing was only able to predict penicillin associated adverse drug reactions in penicillin skin test positive individuals. Excluding accidental penicillin exposure in penicillin skin test positive individuals, non-beta-lactams were associated with adverse drug reactions more often than penicillins or cephalosporins, independent of the penicillin skin test result. Cephalosporins were used as or more safely than non-beta-lactams in both penicillin skin test positive and negative individuals.

  3. Measurement and interpretation of skin prick test results.

    PubMed

    van der Valk, J P M; Gerth van Wijk, R; Hoorn, E; Groenendijk, L; Groenendijk, I M; de Jong, N W

    2015-01-01

    There are several methods to read skin prick test results in type-I allergy testing. A commonly used method is to characterize the wheal size by its 'average diameter'. A more accurate method is to scan the area of the wheal to calculate the actual size. In both methods, skin prick test (SPT) results can be corrected for histamine-sensitivity of the skin by dividing the results of the allergic reaction by the histamine control. The objectives of this study are to compare different techniques of quantifying SPT results, to determine a cut-off value for a positive SPT for histamine equivalent prick -index (HEP) area, and to study the accuracy of predicting cashew nut reactions in double-blind placebo-controlled food challenge (DBPCFC) tests with the different SPT methods. Data of 172 children with cashew nut sensitisation were used for the analysis. All patients underwent a DBPCFC with cashew nut. Per patient, the average diameter and scanned area of the wheal size were recorded. In addition, the same data for the histamine-induced wheal were collected for each patient. The accuracy in predicting the outcome of the DBPCFC using four different SPT readings (i.e. average diameter, area, HEP-index diameter, HEP-index area) were compared in a Receiver-Operating Characteristic (ROC) plot. Characterizing the wheal size by the average diameter method is inaccurate compared to scanning method. A wheal average diameter of 3 mm is generally considered as a positive SPT cut-off value and an equivalent HEP-index area cut-off value of 0.4 was calculated. The four SPT methods yielded a comparable area under the curve (AUC) of 0.84, 0.85, 0.83 and 0.83, respectively. The four methods showed comparable accuracy in predicting cashew nut reactions in a DBPCFC. The 'scanned area method' is theoretically more accurate in determining the wheal area than the 'average diameter method' and is recommended in academic research. A HEP-index area of 0.4 is determined as cut-off value for a

  4. State of the art in non-animal approaches for skin sensitization testing: from individual test methods towards testing strategies.

    PubMed

    Ezendam, Janine; Braakhuis, Hedwig M; Vandebriel, Rob J

    2016-12-01

    The hazard assessment of skin sensitizers relies mainly on animal testing, but much progress is made in the development, validation and regulatory acceptance and implementation of non-animal predictive approaches. In this review, we provide an update on the available computational tools and animal-free test methods for the prediction of skin sensitization hazard. These individual test methods address mostly one mechanistic step of the process of skin sensitization induction. The adverse outcome pathway (AOP) for skin sensitization describes the key events (KEs) that lead to skin sensitization. In our review, we have clustered the available test methods according to the KE they inform: the molecular initiating event (MIE/KE1)-protein binding, KE2-keratinocyte activation, KE3-dendritic cell activation and KE4-T cell activation and proliferation. In recent years, most progress has been made in the development and validation of in vitro assays that address KE2 and KE3. No standardized in vitro assays for T cell activation are available; thus, KE4 cannot be measured in vitro. Three non-animal test methods, addressing either the MIE, KE2 or KE3, are accepted as OECD test guidelines, and this has accelerated the development of integrated or defined approaches for testing and assessment (e.g. testing strategies). The majority of these approaches are mechanism-based, since they combine results from multiple test methods and/or computational tools that address different KEs of the AOP to estimate skin sensitization potential and sometimes potency. Other approaches are based on statistical tools. Until now, eleven different testing strategies have been published, the majority using the same individual information sources. Our review shows that some of the defined approaches to testing and assessment are able to accurately predict skin sensitization hazard, sometimes even more accurate than the currently used animal test. A few defined approaches are developed to provide an

  5. Irritant contact dermatitis in warehouse employees.

    PubMed

    Ashworth, J; Rycroft, R J; Waddy, R S; Irvine, D

    1993-02-01

    A detailed survey of skin complaints amongst 114 airline employees working in a new warehouse revealed 26 cases of skin problems which originated during the 2 1/2 year operation. A clinical survey of broadly the same population confirmed 14 cases from 98 employees as chronic irritant contact dermatitis of the hands. The work involved the reception, unpackaging, inspection, repackaging and dispatch of aircraft parts. The source of the skin irritation was not to be found in the work itself. Rather, the presence among the employees of two severe cases of non-occupational eczema, combined with the idea that incoming aircraft parts from foreign countries might be 'dirty' in some way, had caused a heightened perception of a risk of skin disease, and the frequency of hand washing had increased as a result. Over-frequent hand washing in a few employees had resulted in precisely what the warehouse staff had been trying to avoid.

  6. Skin testing for immediate hypersensitivity to corticosteroids: a case series and literature review.

    PubMed

    Baker, A; Empson, M; The, R; Fitzharris, P

    2015-03-01

    Immediate hypersensitivity to corticosteroids is reported to occur with an incidence of 0.1%. The largest previous case series reporting corticosteroid skin testing has seven patients. We identified 23 patients (mean age 50 years, 65% female) from Auckland City Hospital who underwent skin testing (ST) for suspected corticosteroid hypersensitivity between July 2005 and April 2012. We performed a retrospective clinical case note review detailing clinical history of reaction, skin test results and subsequent management. Most patients (21/23) had a standard panel of testing with prednisolone, triamcinolone, methylprednisolone, hydrocortisone and dexamethasone. Skin tests used a 10% steroid stock concentration for skin prick tests (SPT) and dilutions of 1 : 1000, 1 : 100 and 1 : 10 for subsequent intradermal testing. A weal 3 mm greater than the negative control was considered positive. A total of 23 patients were identified who had skin testing for suspected acute hypersensitivity to corticosteroids, eight of which had a history of anaphylaxis. From 28 reactions (in 23 patients), the most common route of administration was intra-articular (13), followed by oral (7), intravenous (3) and other (5). Skin tests were positive in 8/23 patients, and 7/8 of these patients had a history of corticosteroid-associated anaphylaxis. Skin tests were positive at either the skin prick test or intradermal stages. There was evidence suggesting clinical and skin test cross-reactivity between corticosteroids in one patient. One patient had a positive skin test, but negative oral challenge suggesting the skin test was false positive. Skin tests were negative in 15/23 patients. One patient had a negative prednisolone skin test and positive unblinded oral challenge, suggesting a false-negative skin test. Skin testing can provide sufficient evidence to diagnose allergy in patients with a clear history of immediate hypersensitivity to corticosteroids such as anaphylaxis. Both skin prick

  7. Establishment of a new immortalized human corneal epithelial cell line (iHCE-NY1) for use in evaluating eye irritancy by in vitro test methods.

    PubMed

    Yamamoto, Naoki; Kato, Yoshinao; Sato, Atsushi; Hiramatsu, Noriko; Yamashita, Hiromi; Ohkuma, Mahito; Miyachi, Ei-Ichi; Horiguchi, Masayuki; Hirano, Koji; Kojima, Hajime

    2016-08-01

    In vitro test methods that use human corneal epithelial cells to evaluate the eye irritation potency of chemical substances do not use human corneal epithelium because it has been difficult to maintain more than four passages. In this study, we make a new cell line comprising immortalized human corneal epithelial cells (iHCE-NY1). The IC50 of iHCE-NY1 cells is slightly higher than that of Statens Seruminstitut Rabbit Cornea (SIRC) cells, which are currently used in some in vitro test methods. CDKN1A in iHCE-NY1 cells was used as a marker of gene expression to indicate cell cycle activity. This enabled us to evaluate cell recovery characteristics at concentrations lower than the IC50 of cytotoxic tests.

  8. Is dermatitis palmaris sicca an irritant contact dermatitis?

    PubMed

    Chen, Fu-Juan; Liu, Zhen; Zhou, Ying; Chen, Yong-Hua; Fan, Yi-Ming

    2013-01-01

    Dermatitis palmaris sicca (DPS) is a common dry-fissured palmar dermatitis in Asian women. It may be an irritant contact dermatitis, but the immunophenotype of the cells in its infiltrate is unknown. The aim of this study was to evaluate the role of inflammatory cells in the pathogenesis of DPS. Patch testing was done in 68 patients with DPS, 87 subjects with hand eczema, and 31 healthy subjects. Immunophenotyping of cutaneous inflammatory cells was performed in 8 patients with DPS, 10 subjects with hand eczema, and 8 healthy individuals. Positive patch rates were higher in patients with DPS and those with hand eczema compared with healthy controls, but strong positive (++ or +++) reactions in DPS were fewer compared with hand eczema. Density of CD3, CD4, CD8, and CD68 cells in skin lesions of DPS and hand eczema was significantly higher than that in normal skin. Sparse CD20 cells were present only in hand eczema. Compared with hand eczema, the number of CD3, CD8, CD68, and dermal CD1a cells decreased, but epidermal CD1a cells and CD4/CD8 ratio increased in DPS. The absolute lack of CD20 cells and relative scarcity of dermal CD8 and CD1a cells in skin lesions might be insufficient to induce contact hypersensitivity, so DPS may be an irritant but not allergic contact dermatitis.

  9. Additive impairment of the barrier function and irritation by biogenic amines and sodium lauryl sulphate: a controlled in vivo tandem irritation study.

    PubMed

    Fluhr, J W; Kelterer, D; Fuchs, S; Kaatz, M; Grieshaber, R; Kleesz, P; Elsner, P

    2005-01-01

    Biogenic amines are potential irritants e.g. in fish-, meat-, milk- and egg-processing professions like cooks, butchers and bakers. The aim of this study was to test the irritative and barrier-disrupting properties of the biogenic amines ammonium hydroxide (AM), dimethylamine (DMA) and trimethylamine (TMA). A repeated sequential irritation of 30 min twice per day was performed over a total of 4 days (tandem repeated irritation test) on the back of 20 healthy volunteers of both sexes with AM, DMA, TMA and sodium lauryl sulphate (SLS). The epidermal barrier function was assessed with a Tewameter TM 210, stratum corneum surface pH was measured with a Skin-pH-Meter 900, inflammation was assessed with a Chromameter CR-300 on the a* axis for redness and a visual score was recorded. All tested biogenic amines (AM, DMA and TMA) induced a barrier disruption and a pH increase paralleled with a 1-day-delayed onset of inflammatory signs. These effects were further enhanced and accelerated by a sequential application of SLS together with the biogenic amines, and inflammation occurred earlier than with the single compounds. Acetic acid (AA) in contrast did only show mild barrier disruption and no significant inflammatory signs. Our system allowed a ranking of the different compounds in their irritative potential in the tandem irritation with SLS: SLS > NaOH > TMA > AA > AM > DMA. The results are suggestive that in the food-processing industry the simultaneous contact with biogenic amines and harmful detergents like SLS should be minimized. Copyright 2005 S. Karger AG, Basel.

  10. Efficacy and Tolerability of a Twice-Daily, Three-Step Men's Skincare Regimen in Improving Overall Skin Quality and Reducing Shave-Related Irritation.

    PubMed

    Rodan, Katie; Fields, Kathy; Falla, Timothy J

    2017-01-01

    More men are beginning to take advantage of opportunities to improve the health and appearance of their skin; however, the effectiveness of men's skincare regimens has not been well studied. The authors investigated the efficacy and tolerance of a twice-daily, three-step men's skincare regimen in improving skin appearance and reducing shave-related issues. Twenty-nine men who used a wet-shaving method completed a specific, three-step, twice-daily facial regimen-a Shave Cleanser, a Post-Shave Treatment, and Day Protection-in place of their usual routine for 4 weeks. This skincare regimen produced significant improvements in tactile smoothness, clarity, radiance, and pore size at weeks 2 and 4 and in fine lines, razor burn, and photodamage at week 4 ( P <.05). Significant improvements were seen in the appearance of nicks/cuts and folliculitis of the face and neck after weeks 2 and 4 ( P <.05). Mean change in the moisture content of the stratum corneum was significant at week 4 ( P <.05). The majority of men provided positive self-assessments and indicated an interest in continuing this regimen.

  11. Physical characteristic and irritation index of Syzigium aromaticum essential oil in O/W and W/O creams

    NASA Astrophysics Data System (ADS)

    Safriani, R.; Sugihartini, N.; Yuliani, S.

    2017-11-01

    Essential oil of Syzigium aromaticum has been formulated in O/W and W/O creams as anti-inflammatory dosage form. The purpose of this study was to evaluate the physical characteristic and irritation index of S. aromaticum essential oil in O/W and W/O creams. The creams were made by fusion method. The creams then were evaluated the physical characteristic including pH, viscosity, spreadability and adhesivity. The irritation index was obtained by irritation skin test in male rabbit. The results showed that the W/O and O/W creams have the value of pH: 6.3 and 6.27; spreadability: 3,18 and 4.17 cm2; adhesivity: 5.59 and 0.07 minutes; viscosity: 4.43 and 2.88 Pa.S, respectively. The irritation test showed that the control enhancer caused mild irritation in both of W/O and O/W creams. These findings indicated that type of cream might influence the physical characteristic and irritation index of S. aromaticum essential oil cream.

  12. Comparison of subject-reported allergy versus skin test results in a common cold trial.

    PubMed

    Krahnke, Jason S; Gentile, Deborah A; Cordoro, Kelly M; Angelini, Betty L; Cohen, Sheldon A; Doyle, William J; Skoner, David P

    2003-01-01

    Few studies have examined the relationship between subject-reported allergy and results of allergy skin testing in large unselected or unbiased cohorts. The objective of this study was to compare the results of self-reported allergy via verbal questioning with the results of allergy skin testing by the puncture method in 237 healthy adult subjects enrolled in a common cold study. On enrollment, all subjects were verbally asked if they had a history of allergy and then underwent puncture skin testing to 19 relevant aeroallergens, as well as appropriate positive and negative controls. A skin test was considered positive if its wheal diameter was at least 3 mm larger than that obtained with the negative control. Forty-eight (20%) subjects reported a history of allergy and 124 (52%) subjects had at least one positive skin test response. A history of allergy was reported in 40 (32%) of the skin test-positive subjects and 8 (7%) of the skin test-negative subjects. At least one positive skin test response was found in 40 (83%) of those subjects reporting a history of allergy and 84 (44%) of those subjects denying a history of allergy. These data indicate that there is a relatively poor correlation between self-reported history of allergy and skin test results in subjects enrolled in a common cold study. These results have implications in both clinical practice and research settings.

  13. Characteristics of children with positive tuberculin skin test.

    PubMed

    Hocaoğlu, Arzu Babayiğit; Erge, Duygu Olmez; Anal, Ozden; Makay, Balahan; Uzuner, Nevin; Karaman, Ozkan

    2011-01-01

    The aim of the study was to define the characteristics of children with latent tuberculosis diagnosed with positive tuberculin skin test (TST) and evaluate potential risk factors in children with positive TST. Children followed with the diagnosis of latent tuberculosis infection were included in the study retrospectively. Demographic characteristics of patients including history of atopy, respiratory infections, family history of tuberculosis and atopy, number of BCG vaccinations, findings of physical examination and laboratory data were extracted from patient's file. Eighty-one children (51 male, 30 female) who had positive TST were retrospectively evaluated in the study. Mean age of the patients was 8.00 ± 4.00 years. Only 13 (16%) of the children had contact with a case who had active tuberculosis. It was shown that the age of the patients, number of BCG scars and BCG vaccination significantly affected TST reaction size. TST size was not affected with time passed after last dose of BCG vaccination, family history of tuberculosis, presence of TST positive case in the family, exposure to cigarette smoke, number of household family members and presence of respiratory allergic disease. The patient's age, numbers of BCG vaccination and BCG scars significantly affect TST results in childhood. This may cause difficulty in diagnosing latent tuberculosis infection and in decision of initiating prophylactic treatment. The results of this study may show that recently developed, more accurate and convenient in vitro tests that they have higher costs and require sophisticated laboratory, can be used to diagnose latent tuberculosis.

  14. Intradermal testing after negative skin prick testing for patients with high suspicion of allergy.

    PubMed

    Larrabee, Yuna C; Reisacher, William

    2015-06-01

    Skin testing is a widely accepted method for identifying inhalant allergies. Intradermal (ID) testing is often performed after negative skin prick testing (SPT) when a practitioner has a high level of clinical suspicion for a particular allergen. A retrospective chart review study was performed over a 5-year period in patients with negative SPT for airborne allergens who also underwent ID testing based on a high level of suspicion for clinical allergy. Eighty-seven patients had negative SPT and went on to receive an average of 7 ID tests per patient. A total of 592 ID tests were performed after negative SPT. Of these, 20.8% (123/592) had a positive ID result with negative SPT. The allergens with the greatest percentage of positive ID results with negative SPTs were dog, cat, D. farinae, and D. pteronyssinus (33.3%, 34.3%, 39.4%, and 39.6%, respectively). The allergens least likely to test positive on ID testing after negative SPT were red maple, Cladosporium, and Alternaria (0%, 6.3%, and 6.5%, respectively). Approximately 20% of all negative results on SPT will have a positive ID test, more likely for indoor allergens. If a high suspicion for allergy exists in a patient with a negative SPT result, it may be useful to proceed with ID testing. However, the clinical significance of a positive ID test after negative SPT still needs to be elucidated. © 2015 ARS-AAOA, LLC.

  15. Professors' Irritating Behavior Study

    ERIC Educational Resources Information Center

    Malikow, Max

    2007-01-01

    The purpose of this study was to quantify the irritating behaviors of professors as experienced and reported by 232 Le Moyne College students. In this study, "irritating behavior" was understood as "actions that vex, annoy, bother, pester, frustrate, or provoke anger." The survey used in this study was developed by Larry M. Ludewig, Ph.D.,…

  16. The colour of blood in skin: a comparison of Allen's test and photonics simulations.

    PubMed

    Välisuo, Petri; Kaartinen, Ilkka; Kuokkanen, Hannu; Alander, Jarmo

    2010-11-01

    The colour of the skin reflects many physiological and pathological states of an individual. Usually, the skin colour is examined by the bare eye alone. Several scaling systems have been developed to quantify the sensory evaluation of skin colour. In this work, the reflectance of the skin is measured directly using an objective instrument. Haemoglobin inside the dermal circulation is one of the key factors of skin colour and it also has a major role in the appearance of many skin lesions and scars. To quantitatively measure and analyse such conditions, the relation between the skin colour and the haemoglobin concentration in the skin needs to be resolved. To examine the effect of blood concentration on the skin colour, five Allen's tests were performed on 20 persons. The skin colour change was measured using a spectrophotometer by changing the blood concentration by the Allen's test. Light interaction with the skin was simulated with a Monte Carlo model, tuning the blood concentration parameter until the simulated and the measured spectra matched, yielding the relationship between the skin colour and the blood concentration. The simulation produced spectra similar to those measured. The change in the blood concentration in the simulation model and in the skin produced changes similar to the spectra. The reflectance of the skin was found to be a nonlinear function of the blood concentration. The relationship found between skin colour and blood concentration makes it possible to quantify those skin conditions expressed by blood volume better than plain colour. © 2010 John Wiley & Sons A/S.

  17. Surfactant irritation: in vitro corneosurfametry and in vivo bioengineering.

    PubMed

    Gabard, B; Chatelain, E; Bieli, E; Haas, S

    2001-02-01

    Irritant reactions to surfactants, cleansing products, soaps and detergents are common in clinical and occupational dermatology. Mildness has become a major benefit claimed, and testing for mildness now ranks among the first concerns of the manufacturing industry. A wealth of publications deals with this problem, trying to improve the methodology, reduce the costs of testing and facilitate decision-making. Differences in vivo can be measured clinically and/or instrumentally. This is difficult, as commercially available products are generally safe to use and none are harsh in the absolute sense. Nineteen different products (syndets, shampoos, personal cleansers), all claiming to be mild, were tested in vitro by a newly introduced method, corneosurfametry. For evaluating the aggressiveness of the products, the calculation of an index of irritation (IOI) was proposed. A concentration-effect curve of sodium lauryl sulfate (SLS) as standard and model surfactant was obtained. Some of the products were further tested in vivo with a flex wash test and with a soap chamber test and compared to SLS. Bioengineering methods (transepidermal water loss TEWL, skin color) were used to evaluate the results. The results of the corneosurfametry allowed us to classify the products in three categories, with increasing aggressiveness towards the stratum corneum, according to their IOIs. The in vivo tests were not able to discriminate between the products, but ranks from the results of the bioengineering measurements showed a good correlation between TEWL changes, but not between colour changes, and IOIs from corneosurfametry. Corneosurfametry emerged as a simple, low-cost and fast method for ranking commercial products according to their mildness. However, the skin bioengineering techniques showed that some products could lead to skin reactions, such as erythema, that could not be detected by the in vitro technique.

  18. Skin testing only with penicillin G in children with a history of penicillin allergy.

    PubMed

    Picard, Matthieu; Paradis, Louis; Bégin, Philippe; Paradis, Jean; Des Roches, Anne

    2014-07-01

    The absence of commercially available penicilloyl-polylysine (PPL) for most of the last decade severely hampered the practice of penicillin allergy evaluation because skin testing without PPL is reported to have a poor negative predictive value (NPV). To determine the safety and NPV of skin testing without PPL using only penicillin G followed by a 3-dose graded challenge to the incriminated penicillin in children with a history of penicillin allergy. Patients evaluated for a history of penicillin allergy at the CHU Sainte-Justine Allergy Clinic between December 2006 and December 2009 were skin tested only with penicillin G and underwent a 3-dose graded challenge to the culprit penicillin if the skin test result was negative. Among 563 patients skin tested to penicillin G, 185 (33%) had a positive skin test result. These patients had a shorter interval between the initial reaction and skin testing compared with patients with a negative skin test result (P = .03). A total of 375 of 378 patients (99%) with a negative skin test result were challenged and 18 (4.8%) reacted, translating into a NPV of 95.2% (95% confidence interval [CI], 92.5%-97.1%). Three of 17 patients with a history of anaphylaxis and a negative skin test result reacted to challenge (NPV, 82.4%; 95% CI, 59.0-93.8%). All challenge reactions were mild and resolved promptly with treatment. Among children with a history of penicillin allergy, skin testing only with penicillin G followed by a 3-dose graded challenge to the incriminated penicillin is safe and yields a good NPV. This approach could be useful when PPL is unavailable. Copyright © 2014 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  19. Where to prick the apple for skin testing?

    PubMed

    Vlieg-Boerstra, B J; van de Weg, W E; van der Heide, S; Dubois, A E J

    2013-09-01

    Mal d 1 is not equally distributed over the apple. We aimed to examine the influence of the location of pricking in the apple on prick-to-prick skin prick test (PTP) results. PTPs were performed in autumn 2007 and spring 2008, before the birch pollen season, in 32 Dutch adults with symptoms of oral allergy to fresh apple, using apples harvested in autumn 2007. PTPs with fresh intact and unpeeled Pink Lady, Golden Delicious, Elise, Santana and Modi apples were performed using material obtained from approximately 2 cm near the stalk (top), and the middle region. All PTP responses were greater when performed with apple material near the stalk than from the middle region. In 2007, these differences were statistically significant for Pink Lady, Golden Delicious and Elise, and in 2008, for Pink Lady and Modi. When performing PTPs, the apple should be pricked near the stalk rather than in the middle. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. Penicillin skin testing in the evaluation and management of penicillin allergy.

    PubMed

    Fox, Stephanie; Park, Miguel A

    2011-01-01

    to review the role of penicillin skin testing in the evaluation and management of penicillin allergy mediated by IgE. PubMed and OVID search of English-language articles regarding penicillin allergy, penicillin allergy testing, and management of penicillin allergy. articles pertinent to the subject matter were selected and reviewed. the major determinant (benzylpenicillin polylysine) detects the greatest number of penicillin allergic patients during skin testing, and the minor determinants of penicillin increase the sensitivity of penicillin skin testing. Penicillin skin testing to the major and minor determinants was found to have a negative predictive value of 97% to 99%. The incidence of systemic adverse reaction to penicillin skin testing is less than 1%. a detailed history of the prior reaction to penicillin is an integral part of the evaluation, but it is not accurate in predicting a positive penicillin skin test result. A patient with a negative penicillin skin test result to the major and minor determinants is at a low risk of an immediate-type hypersensitivity reaction to penicillin. Patients with a positive skin test result should undergo desensitization to penicillin or an alternative antibiotic should be considered.

  1. Skin models for the testing of transdermal drugs

    PubMed Central

    Abd, Eman; Yousef, Shereen A; Pastore, Michael N; Telaprolu, Krishna; Mohammed, Yousuf H; Namjoshi, Sarika; Grice, Jeffrey E; Roberts, Michael S

    2016-01-01

    The assessment of percutaneous permeation of molecules is a key step in the evaluation of dermal or transdermal delivery systems. If the drugs are intended for delivery to humans, the most appropriate setting in which to do the assessment is the in vivo human. However, this may not be possible for ethical, practical, or economic reasons, particularly in the early phases of development. It is thus necessary to find alternative methods using accessible and reproducible surrogates for in vivo human skin. A range of models has been developed, including ex vivo human skin, usually obtained from cadavers or plastic surgery patients, ex vivo animal skin, and artificial or reconstructed skin models. Increasingly, largely driven by regulatory authorities and industry, there is a focus on developing standardized techniques and protocols. With this comes the need to demonstrate that the surrogate models produce results that correlate with those from in vivo human studies and that they can be used to show bioequivalence of different topical products. This review discusses the alternative skin models that have been developed as surrogates for normal and diseased skin and examines the concepts of using model systems for in vitro–in vivo correlation and the demonstration of bioequivalence. PMID:27799831

  2. Effect of nutritional status on Tuberculin skin testing.

    PubMed

    Piñeiro, Roi; Cilleruelo, María José; García-Hortelano, Milagros; García-Ascaso, Marta; Medina-Claros, Antonio; Mellado, María José

    2013-04-01

    To evaluate Tuberculin skin test (TST) results in a population of immigrants and internationally adopted children from several geographical areas; to analyze whether nutritional status can modify TST results. This cross-sectional observational study included adopted children and immigrants evaluated in the authors' unit between January 2003 and December 2008. Children diagnosed with tuberculosis, or vaccinated with live attenuated virus 2 mo earlier, HIV-infected, chronically ill or under treatment with immunosuppressive agents were excluded. TST was considered as dependent variable. Independent variables were gender, age, geographical origin, BCG scar, nutritional status, immune status and intestinal parasitism. One thousand seventy four children were included; 69.6 % were girls. There was a BCG scar in 79 % of children. Mantoux = 0 mm was found in 84.4 %, <10 mm in 4.1 %, and ≥10 mm in 11.4 % of children. Nutrition (McLaren's classification) was normal (≥90 %) in 26.7 % of the subjects, with mild malnutrition (80-89 %) in 36 %, moderate (70-79 %) in 23.2 % and severe (≤69 %) in 14.1 %. There was no difference in TST results among different nutritional status children. The nutritional status, measured by McLaren's classification, does not changes the results of TST. McLaren's classification only grades protein-caloric malnutrition, so in authors' experience this type of malnutrition does not interfere with TST results. Implementing other nutritional parameters could help to determine whether nutritional status should be taken into account when interpreting TST results.

  3. The Use of Telemedicine for Penicillin Allergy Skin Testing.

    PubMed

    Staicu, Mary L; Holly, Anne Marie; Conn, Kelly M; Ramsey, Allison

    2018-05-08

    Penicillin skin testing (PST) is increasingly used as a tool to evaluate penicillin allergy in patients with a reported history. The limited availability of allergists, however, may be an impeding factor. We sought to assess the clinical utility of telemedicine to facilitate PST. Penicillin-allergic inpatients receiving systemic antibiotics were prospectively identified between April and August 2017. Qualifying patients underwent PST performed by a trained allergy/immunology physician assistant (PA). On completion of PST, a telemedicine consultation, through the use of real-time interactive video conferencing (Microsoft Lync 2013, Redmond, Wash), was performed remotely by an allergist. Patients were surveyed regarding their satisfaction with the telemedicine experience. Fifty patients consented to PST through a telemedicine consultation. The average total time to complete a consultation was 128 minutes (standard deviation [SD] ± 33). Of this, the average PA travel time was 46 minutes (36%) with the remaining time spent on clinical services (82 minutes, 64%). The average physician telemedicine time per patient was 5 minutes (SD ± 2). Patients rated their experience as an average of 4.5 on a scale of 1 (highly unsatisfied) to 5 (highly satisfied). Of the 46 PST-negative patients, 33 were transitioned to a β-lactam antibiotic that reduced the use of vancomycin, metronidazole, aztreonam, aminoglycosides, and clindamycin (P < .05). More than $30,000 was saved throughout the study period. Telemedicine is an effective and novel approach to facilitate PST in the inpatient setting and carries a high degree of patient satisfaction. This method has the potential to optimize and improve access to allergy/immunology resources. Copyright © 2018 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  4. Use of intradermal dilutional testing and skin prick testing: clinical relevance and cost efficiency.

    PubMed

    Seshul, Merritt; Pillsbury, Harold; Eby, Thomas

    2006-09-01

    The objective was to determine the agreement of the positive results from a multiple skin prick test (SPT) device with the ability to determine a definable endpoint through intradermal dilutional testing (IDT) to compare semiquantitatively the degree of positivity of SPT results with quantitative results from IDT and to analyze the cost of immunotherapy based on SPT compared with IDT guided by SPT. Retrospective review of clinical data (random accrual). One hundred thirty-four patients underwent allergy screening using a multiple SPT device. Antigens testing positive by skin prick device were tested using IDT on a separate day. Antigens testing negative by SPT were not evaluated by IDT. Regional allergy testing practice patterns were determined, and a cost analysis using Medicare rates was performed There was good agreement between an antigen testing positive by SPT and the determination of a definable endpoint (93.33%, n = 1,334 antigens). The degree of positivity from the SPT correlated poorly with the final endpoint concentration (r = 0.40, P < .0001). Blended testing techniques were similar in cost when compared with several commonly used allergy testing protocols. Antigens which show reactivity to a multiple SPT device usually have a treatable endpoint that is independent of the degree of positivity of the SPT result. IDT is an important step in the determination of the strongest starting dose of immunotherapy that may be safely administered. Initiating immunotherapy in this manner may potentially create significant health care savings by shortening the time required for a patient to reach their individual maximally tolerated dose. The use of a relatively large screening panel is cost effective and does not increase the average number of antigens treated by immunotherapy. Blended allergy testing techniques that include IDT in their protocol are comparable in cost with commonly used allergy testing protocols.

  5. Insertion Testing of Polyethylene Glycol Microneedle Array into Cultured Human Skin with Biaxial Tension

    NASA Astrophysics Data System (ADS)

    Takano, Naoki; Tachikawa, Hiroto; Miyano, Takaya; Nishiyabu, Kazuaki

    Aiming at the practical use of polyethylene glycol (PEG) microneedles for transdermal drug delivery system (DDS), a testing apparatus for their insertion into cultured human skin has been developed. To simulate the variety of conditions of human skin, biaxial tension can be applied to the cultured human skin. An adopted testing scheme to apply and control the biaxial tension is similar to the deep-draw forming technique. An attention was also paid to the short-time setup of small, thin and wet cultured skin. One dimensional array with four needles was inserted and influence of tension was discussed. It was found that tension, deflection of skin during insertion and original curvature of skin are the important parameters for microneedles array design.

  6. [Incidence of irritant dermatosis among employees of the shipbuilding industry].

    PubMed

    Heise, H; Kühne, G; Kröger, D

    1983-10-01

    Irritant dermatosis is a non-specific reactive change on the skin. In most cases it represents the summated effects induced by various agents. Not only the shortened recovery phases of the skin but also a dispositional factor are important. Such changes, which are relatively common in some vocations but are usually only slight, cannot, as a rule, be regarded as signs of illness. Nevertheless, attention should be drawn to the necessity of intensive skin care and observation of the recovery phases because the frequency of irritant dermatosis can increase with increasing length of employment.

  7. Evaluation of 4-methylcyclohexanemethanol (MCHM) in a combined irritancy and Local Lymph Node Assay (LLNA) in mice.

    PubMed

    Johnson, Victor J; Auerbach, Scott S; Luster, Michael I; Waidyanatha, Suramya; Masten, Scott A; Wolfe, Mary S; Burleson, Florence G; Burleson, Gary R; Germolec, Dori R

    2017-07-01

    4-Methylcyclohexanemethanol (MCHM) is a flotation reagent used in fine coal beneficiation. On January 9, 2014, crude MCHM, a mixture containing predominantly MCHM, was inadvertently released into the Elk River, a municipal water source that serves about 300,000 people in the Charleston, WV area, resulting in temporary contamination of 15 percent of the state's tap water and causing significant dermal exposure. The current studies were undertaken to determine whether crude MCHM or MCHM has the potential to produce dermal irritancy and/or sensitization. BALB/c female mice were treated daily for 3 consecutive days by direct epicutaneous application of 25 μL of various concentrations of crude MCHM or MCHM to the dorsum of each ear. A mouse ear-swelling test was used to determine irritancy potential and was undertaken in combination with the standardized Local Lymph Node Assay (LLNA) to determine skin sensitizing potential. MCHM was found to produce skin irritation at concentrations above 20% and did not produce sensitization. Crude MCHM also produced irritation, although weaker, and in addition was found to be a weak to moderate skin sensitizer. The results are discussed in terms of potential human health hazard. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Irritable bowel syndrome

    MedlinePlus

    ... Side Effects of Drugs . 16th ed. Philadelphia, PA: Elsevier; 2016:488-494. Canavan C, West J, Card ... FF, ed. Ferri's Clinical Advisor 2018 . Philadelphia, PA: Elsevier; 2018:722-725. Ford AC, Talley NJ. Irritable ...

  9. Irritable Bowel Syndrome

    MedlinePlus

    Irritable bowel syndrome (IBS) is a problem that affects the large intestine. It can cause abdominal cramping, bloating, and a change in bowel ... go back and forth between the two. Although IBS can cause a great deal of discomfort, it ...

  10. Combining skin prick, immediate skin application and specific-IgE testing in the diagnosis of peanut allergy in children.

    PubMed

    Wainstein, Brynn Kevin; Yee, Anthony; Jelley, Donna; Ziegler, Mary; Ziegler, John B

    2007-05-01

    Previous studies have suggested various diagnostic cut-offs of allergy tests for the diagnosis of clinical peanut allergy in children. There are few data relating to the use of combinations of these tests in children. We aimed to determine the validity of previously reported diagnostic cut-off levels of peanut allergen skin tests and peanut specific-immunoglobulin (Ig) E, as well as the usefulness of combinations of these, for predicting clinical peanut allergy in our Allergy Clinic. Children attending the Allergy Clinic with a positive peanut skin prick test (SPT; n = 84) were included in the study. Immediate skin application food tests (I-SAFT) using 1 g of peanut butter (positive if any wheals were detected at 15 min), peanut specific-IgE levels and open-label peanut food challenges were performed. Fifty-two of 85 peanut challenges were positive. Skin prick test specificity was 67% at >or=8 mm and 100% at >or=15 mm. The I-SAFT was 82% specific. A peanut specific-IgE level of 0.37 kU/l was 98% sensitive but 33% specific. A level of 10 kU/l was 100% specific. Combinations of a SPT of >or=8 mm with a positive I-SAFT and a peanut specific-IgE >or=0.37 kU/l were 88% specific with a sensitivity of 38%. Using challenge outcomes as the standard, available in vitro and in vivo diagnostic tests for peanut allergy have poor sensitivity and specificity and combining them does not significantly improve their clinical usefulness. Previously described diagnostic cut-off levels do not have general applicability. Allergy practitioners may need to interpret results of allergy tests in the context of their own practices.

  11. Skin testing and oral penicillin challenge in patients with a history of remote penicillin allergy.

    PubMed

    Goldberg, Arnon; Confino-Cohen, Ronit

    2008-01-01

    Penicillin administration is usually contraindicated in penicillin-allergic patients with positive skin test results. To examine whether penicillin oral challenge for patients with a history of remote non-life-threatening allergic reaction to penicillin can be well tolerated irrespective of skin test results. In a prospective open-label trial, 8,702 individuals were screened between November 1998 and January 2000. Of 687 patients with a non-life-threatening allergic reaction to penicillin, occurring longer than 3 years earlier, 169 were enrolled. Regardless of the response to penicillin skin testing, patients received the usual 1-day dosage of penicillin and amoxicillin, on 2 separate occasions. Two to 6 years later, a follow-up was conducted to assess the outcomes of further penicillin administration. A total of 272 combined skin tests and oral challenges were performed on 169 patients. Among 137 challenges with a positive skin test result and 135 patients with a negative skin test result, 9 (6.6%) and 5 (3.7%) (P = .29), respectively, developed a mild rash to oral challenge. At follow-up, 2 to 6 years afterward, 3 of 55 patients (5.5%) who were given a full treatment course of penicillin developed a mild skin eruption. Positive penicillin skin test results for patients with a remote history of non-life-threatening allergic reaction to penicillin were not associated with a greater prevalence of adverse reactions to oral challenge with penicillin than negative results. Because skin testing is considered the gold standard and the safest method for predicting tolerance to penicillin administration, oral penicillin challenge may be used as a diagnostic method only in these specific patients when skin testing is not feasible.

  12. Evaluation of skin test reactivity to environmental allergens in healthy cats and cats with atopic dermatitis.

    PubMed

    Schleifer, Sebastian G; Willemse, Ton

    2003-06-01

    To evaluate skin test reactivity to environmental allergens in healthy cats and in cats with atopic dermatitis (AD). 10 healthy cats and 10 cats with AD. 10 allergens in serial dilutions were injected ID on the lateral aspect of the thorax of sedated cats. Histamine (0.01% solution) and buffer solutions were used as positive and negative controls, respectively. Immediately after the last injection, 10% fluorescein solution was administered IV. Skin test results were evaluated with ultraviolet light after 15 to 30 minutes and at 4 and 6 hours by 2 independent observers. In the control group, skin tests were repeated after 6 weeks. Skin test reactivity and the nature of the immunoglobulin involved were investigated by use of the Prausnitz-Küstner test with untreated and heat-treated cat sera. Intertest and interobserver agreement were high when measurement of the diameter of the fluorescent wheal was used to evaluate skin test responses, compared with assessment of its intensity. In both groups of cats, immediate skin test reactivity was observed as an IgE-mediated reaction, as an IgG-mediated reaction, and as a result of nonspecific mast cell degranulation. There was no correlation between allergen concentration and the type of reaction observed. Skin test reactivity in cats should be evaluated after IV administration of 10% fluorescein solution by means of a Prausnitz-Küstner test to differentiate among IgE-mediated, IgG-mediated, and nonspecific reactions.

  13. Differences in Cutaneous Irritation of Five Commonly Used Topical Products.

    PubMed

    Draelos, Zoe Diana

    2016-07-01

    Irritation, such as burning and stinging, on the site of application, is a common side effect of topical dermatologic products including creams, lotions, sprays, and foams. This effect may be more pronounced when applying products to atopic or psoriatic skin. The composition of the vehicle may affect the extent of the irritation. This study compared the irritation and erythema potential of 7 different topical dermatologic products to determine the products with the least likelihood of causing discomfort when applied.
    Seven sites on the anterior leg of 30 subjects were dry shaven with 10 upward strokes. Subjects rated the stinging of petrolatum (negative control), isopropyl alcohol (positive control), Cetaphil Lotion, triamcinolone 0.1% cream, triamcinolone 0.2% spray, betamethasone foam, and clobetasol 0.05% spray, 1 minute after product application, using a scale of 0 (no symptoms) to 10 (intolerable stinging/burning). The investigator assessed erythema at the sites 30 minutes after application of the products using a scale of 0 (none) to 4 (severe).
    Stinging rating score of each product was statistically significant from one another. Petrolatum produced the least stinging (0) and isopropyl alcohol the most (10). Stinging with triamcinolone spray, Cetaphil Lotion, and triamcinolone cream ranked in the lower half of the rating scale (all below 5). Betamethasone foam and clobetal spray ranked the highest at >7. When corrected for the erythema caused by shaving, triamcinolone spray and Cetaphil Lotion produced the least amount of erythema of all the products tested.
    Rapid evaporation of the volatile vehicle of triamcinolone spray and the non-irriating nature of the medication left behind may contribute to its low erythema and stinging. This product may be an appropriate choice for patients with compromised skin but who require the advantages and conveniences of a spray vehicle.

    J Drugs Dermatol. 2016;15(7):870-873.

  14. An analysis of skin prick test reactions in 656 asthmatic patients.

    PubMed Central

    Hendrick, D J; Davies, R J; D'Souza, M F; Pepys, J

    1975-01-01

    Of 656 asthmatic patients referred specifically for allergy assessments, 544 (84 percent) gave positive immediate skin prick tests to at least one of 22 common allergens used routinely. Comparison of these skin test positive patients with the 102 (16 percent) who were skin test negative showed a number of significant differences. The majority of the skin test positive patients (52 percent) were less than 10 years old at the time of onset of the asthma, whereas, of the skin test negative patients, 56 percent were aged over 30 years at the time of onset. Seventy per cent report rhinitis compared with 48 per cent of the skin test negative patients, and 29 per cent reported infantile eczema compared with 9 per cent. Symptoms attributed to house dust, pollens, and animals were noted two to three times more frequently by the skin test positive patients, while corticosteroid drugs had been used more commonly by the skin test negative patients (45 percent compared with 35 percent). No significant differences were observed with the other factors studied, namely, history of urticaria or angio-oedema, family history of "allergic" disease, and awareness of sensitivity to foods, aspirin or penicillin. Prick test reactions in the skin test positive patients were most commonly seen to house dust or the acarine mite, Dermatophagoides farinae (82 percent), followed by pollens (66 percent), animal danders (38 percent), foods (16 percent), Aspergillus fumigatus (16 percent), and other moulds (21 percent). There was a highly significant association of positive history with positive prick test for all allergens studied. Images PMID:1168378

  15. An analysis of skin prick test reactions in 656 asthmatic patients.

    PubMed

    Hendrick, D J; Davies, R J; D'Souza, M F; Pepys, J

    1975-02-01

    Of 656 asthmatic patients referred specifically for allergy assessments, 544 (84 percent) gave positive immediate skin prick tests to at least one of 22 common allergens used routinely. Comparison of these skin test positive patients with the 102 (16 percent) who were skin test negative showed a number of significant differences. The majority of the skin test positive patients (52 percent) were less than 10 years old at the time of onset of the asthma, whereas, of the skin test negative patients, 56 percent were aged over 30 years at the time of onset. Seventy per cent report rhinitis compared with 48 per cent of the skin test negative patients, and 29 per cent reported infantile eczema compared with 9 per cent. Symptoms attributed to house dust, pollens, and animals were noted two to three times more frequently by the skin test positive patients, while corticosteroid drugs had been used more commonly by the skin test negative patients (45 percent compared with 35 percent). No significant differences were observed with the other factors studied, namely, history of urticaria or angio-oedema, family history of "allergic" disease, and awareness of sensitivity to foods, aspirin or penicillin. Prick test reactions in the skin test positive patients were most commonly seen to house dust or the acarine mite, Dermatophagoides farinae (82 percent), followed by pollens (66 percent), animal danders (38 percent), foods (16 percent), Aspergillus fumigatus (16 percent), and other moulds (21 percent). There was a highly significant association of positive history with positive prick test for all allergens studied.

  16. Feasibility, Benefits, and Limitations of a Penicillin Allergy Skin Testing Service.

    PubMed

    Narayanan, Prasanna P; Jeffres, Meghan N

    2017-06-01

    To critically examine the feasibility, benefits, and limitations of an inpatient penicillin skin testing service and how pharmacists can be utilized. A PubMed search was performed from July 2016 through September 2016 using the following search terms: penicillin skin testing, penicillin allergy, β-lactam allergy. Additional references were identified from a review of literature citations. All English-language studies assessing the use of penicillin skin testing as well as management and clinical outcomes of patients with a β-lactam allergy were evaluated. The prevalence of people self-identifying as penicillin allergic ranges from 10% to 20% in the United States. Being improperly labeled as penicillin allergic is associated with higher health care costs, worse clinical outcomes, and an increased prevalence of multidrug-resistant infections. Penicillin skin testing can be a tool used to clarify penicillin allergies and has been demonstrated to be a successful addition to antimicrobial stewardship programs in multiple health care settings. Prior to implementing a penicillin skin testing service, institutions will need to perform a feasibility analysis of who will supply labor and accept the financial burden as well as identify if the positive benefits of a penicillin skin testing service overcome the limitations of this diagnostic test. We conclude that institutions with high percentages of patients receiving non-β-lactams because of penicillin allergy labels would likely benefit the most from a penicillin skin testing service.

  17. Interactions of skin thickness and physicochemical properties of test compounds in percutaneous penetration studies.

    PubMed

    Wilkinson, Simon C; Maas, Wilfred J M; Nielsen, Jesper Bo; Greaves, Laura C; van de Sandt, Johannes J M; Williams, Faith M

    2006-05-01

    To determine the effect of skin thickness on the percutaneous penetration and distribution of test compounds with varying physicochemical properties using in vitro systems. Studies were carried out in accordance with OECD guidelines on skin absorption tests. Percutaneous penetration of caffeine (log P -0.01), testosterone (log P 3.32), propoxur (log P 1.52) (finite dose in ethanol to water vehicle ratio) and butoxyethanol (log P 0.83) (undiluted finite dose or as an infinite dose 50% [v/v] aqueous solution) through skin of varying thicknesses under occluded conditions was measured using flow through cells for 8-24 h. Saline (adjusted to pH 7.4) was used as receptor fluid, with BSA added for studies with testosterone and propoxur. Following exposure, the remaining surface dose was removed by swabbing and the skin digested prior to scintillation counting. The maximum flux of caffeine was increased with decreasing skin thickness, although these differences were found to be non-significant. The presence of caffeine in the skin membrane was not altered by skin thickness. Maximum flux and cumulative dose absorbed of testosterone and butoxyethanol (in both finite and infinite doses) were markedly reduced with full thickness (about 1 mm thick) skin compared with split thickness skin (about 0.5 mm). Maximum flux of propoxur (dissolved in 60% ethanol) was clearly higher through skin of 0.71 mm than through skin of 1.36 mm, but no difference was found between 0.56 and 0.71 mm. The proportion of propoxur present in the membrane after 24 h increased significantly over the complete range of thicknesses tested (0.56-1.36 mm). A complex relationship exists between skin thickness, lipophilicity and percutaneous penetration and distribution. This has implications for risk assessment studies and for the validation of models with data from different sources.

  18. Immediate hypersensitivity to iodinated contrast media: diagnostic accuracy of skin tests and intravenous provocation test with low dose.

    PubMed

    Sesé, L; Gaouar, H; Autegarden, J-E; Alari, A; Amsler, E; Vial-Dupuy, A; Pecquet, C; Francès, C; Soria, A

    2016-03-01

    The diagnosis of HSR to iodinated contrast media (ICM) is challenging based on clinical history and skin tests. This study evaluates the negative predictive value (NPV) of skin tests and intravenous provocation test (IPT) with low-dose ICM in patients with suspected immediate hypersensitivity reaction (HSR) to ICM. Thirty-seven patients with suspected immediate hypersensitivity reaction to ICM were included retrospectively. Skin tests and a single-blind placebo-controlled intravenous provocation test (IPT) with low-dose iodinated contrast media (ICM) were performed. Skin tests with ICM were positive in five cases (one skin prick test and five intradermal test). Thirty-six patients were challenged successfully by IPT, and only one patient had a positive challenge result, with a grade I reaction by the Ring and Messmer classification. Ten of 23 patients followed up by telephone were re-exposed to a negative tested ICM during radiologic examination; two experienced a grade I immediate reaction. For immediate hypersensitivity reaction to ICM, the NPV for skin tests and IPT with low dose was 80% (95% CI 44-97%). © 2016 John Wiley & Sons Ltd.

  19. Development of action levels for MED/MPD skin-testing units in ultraviolet phototherapy

    NASA Astrophysics Data System (ADS)

    O'Connor, Una M.; O'Hare, Neil J.

    2003-03-01

    Ultraviolet (UV) Phototherapy is commonly used for treatment of skin diseases such as psoriasis and eczema. Treatment is carried out using UV phototherapy units, exposing all or part of the body for a certain exposure time. Prior to exposure in treatment units, an unaffected area of skin may be tested using UV skin-testing units in order to determine a suitable treatment regime. The exposure time at which barely perceptible erythema has developed is known as the Minimal Erythemal Dose (MED) for UVB therapy and Minimal Phototoxic Dose (MPD) for UVA therapy. This is used to determine the starting dose in the treatment regime. The presence of 'hotspots' and 'coldspots' in UV skin-testing units can result in inaccurate determination of MED/MPD. This could give rise to severe burns during treatment, or in a sub-optimal dose regime being used. Quality assurance protocols for UV phototherapy equipment have recently been developed and these protocols have highlighted the need for action levels for skin-testing units. An action level is a reference value, which is used to determine whether the difference in irradiance output level across a UV unit is acceptable. Current methodologies for skin-testing in Ireland have been characterised and errors introduced during testing have been estimated. Action levels have been developed based on analysis of errors and requirements of skin-testing.

  20. A tuberculin skin test survey among Ghanaian school children.

    PubMed

    Addo, Kennedy Kwasi; van den Hof, Susan; Mensah, Gloria Ivy; Hesse, Adukwei; Bonsu, Christian; Koram, Kwadwo Ansah; Afutu, Felix Kwami; Bonsu, Frank Adae

    2010-01-26

    Ghana has not conducted a national tuberculin survey or tuberculosis prevalence survey since the establishment of the National Tuberculosis Control Programme. The primary objective of this study was therefore to determine the prevalence of tuberculin skin sensitivity in Ghanaian school children aged 6-10 years in 8 out of 10 regions of Ghana between 2004 and 2006. Tuberculin survey was conducted in 179 primary schools from 21 districts in 8 regions. Schools were purposively selected so as to reflect the proportion of affluent private and free tuition public schools as well as the proportion of small and large schools. Of the 24,778 children registered for the survey, 23,600 (95.2%) were tested of which 21,861 (92.6%) were available for reading. The age distribution showed an increase in numbers of children towards older age: 11% of the children were 6 years and 25%, 10 years. Females were 52.5% and males 47.5%. The proportion of girls was higher in all age groups (range 51.4% to 54.0%, p < 0.001). BCG scar was visible in 89.3% of the children. The percentage of children with a BCG scar differed by district and by age. The percentage of children with a BCG scar decreased with increasing age in all districts, reflecting increasing BCG vaccination coverage in Ghana in the last ten years. The risk of tuberculosis infection was low in the northern savannah zones compared to the southern coastal zones. Using a cut-off of 15 mm, the prevalence of infection ranged from 0.0% to 5.4% and the Annual Risks of Tuberculosis Infection 0.0% to 0.6%. There was an increase in the proportion of infected children after the age of 7 years. Children attending low and middle-class schools had a higher risk of infection than children attending upper-class schools. Tuberculosis infection is still a public health problem in Ghana and to monitor the trend, the survey needs to be repeated at 5 years interval.

  1. Infant Skin Care Products: What Are the Issues?

    PubMed

    Kuller, Joanne McManus

    2016-10-01

    Infant skin is susceptible to dryness and irritation from external factors, including topical skin care products not formulated for the infant's skin. This may increase the risk of contact dermatitis. Parents frequently express concern regarding potential harm from ingredients in skin care products and seek information. This is complicated by several skin care myths. The purpose of this literature review was to provide evidence-based information to educate parents on the use of products for preterm and term infants. Multiple searches using PubMed were conducted including the search terms "infant skin care," "infant products," "infant bath," "emollients," "diaper skin care," and "diaper wipes." Reference lists of comprehensive reviews were also scanned. Google searches were used to assess consumer information, product information, and regulatory guidelines. There is little scientific evidence to support safety of natural/organic products on infant skin. Raw materials originate from different sources, complicating testing and comparisons of ingredients. Research shows that cleansers formulated for infant skin do not weaken the skin barrier the way harsher soaps and detergents can. Oils with the lowest oleic acid content provide a lower risk of irritant contact dermatitis. Nurses must be informed about natural and organic products, preservatives, and fragrances and know the definition of commonly used marketing terms. Decisions regarding the use of infant products in preterm and term infants should be evidence based. More research is needed to support claims regarding the safety of products used on infant skin.

  2. Evaluation of a three-dimensional human dermal model as a predictor of shampoo ocular irritation.

    PubMed

    Decker, D; Harper, R

    1994-04-01

    A three-dimensional human tissue model (Skin(2) ZK1100) was used to evaluate 43 adult and baby shampoos. The ZK1100 model consists of metabolically active proliferating human fibroblasts isolated from the dermis of neonatal foreskins and seeded onto a nylon mesh. The fibroblasts multiply and produce matrix proteins to form a living tissue. MTT reduction (mitochondrial function) was used as the cytotoxicity endpoint. The primary components of the adult shampoos are alkyl sulfate surfactants, while the baby shampoos contain ethoxylated alkyl sulfates and amphoteric surfactants. All shampoos were diluted to five concentrations (100, 300, 700, 1000 and 3000 mug/ml) in aqueous cell culture media and the tissue exposed for 24 hr. An EC(50) value for each test was generated from a dose-response curve. All samples were tested in two or more separate experiments, and the EC(50) values were averaged and plotted versus their respective 24-hr unwashed Draize eye irritation values (r(2) = 0.81). The adult shampoos had Draize values in the moderate irritation category and EC(50) values ranging from 220 to 1051 mug/ml, while the baby shampoos had Draize values in the minimal irritation category and EC(50) values ranging from 820 to 2285 mug/ml. These results indicate that the three-dimensional human tissue model can be useful in predicting the Draize ocular irritation category for shampoos.

  3. Factors influencing and modifying the decision to pursue genetic testing for skin cancer risk.

    PubMed

    Fogel, Alexander L; Jaju, Prajakta D; Li, Shufeng; Halpern-Felsher, Bonnie; Tang, Jean Y; Sarin, Kavita Y

    2017-05-01

    Across cancers, the decision to pursue genetic testing is influenced more by subjective than objective factors. However, skin cancer, which is more prevalent, visual, and multifactorial than many other malignancies, may offer different motivations for pursuing such testing. The primary objective was to determine factors influencing the decision to receive genetic testing for skin cancer risk. A secondary objective was to assess the impact of priming with health questions on the decision to receive testing. We distributed anonymous online surveys through ResearchMatch.org to assess participant health, demographics, motivations, and interest in pursuing genetic testing for skin cancer risk. Two surveys with identical questions but different question ordering were used to assess the secondary objective. We received 3783 responses (64% response rate), and 85.8% desired testing. Subjective factors, including curiosity, perceptions of skin cancer, and anxiety, were the most statistically significant determinants of the decision to pursue testing (P < .001), followed by history of sun exposure (odds ratio 1.85, P < .01) and history of skin cancer (odds ratio 0.5, P = .01). Age and family history of skin cancer did not influence this decision. Participants increasingly chose testing if first queried about health behaviors (P < .0001). The decision to pursue hypothetical testing may differ from in-clinic decision-making. Self-selected, online participants may differ from the general population. Surveys may be subject to response bias. The decision to pursue genetic testing for skin cancer is primarily determined by subjective factors, such as anxiety and curiosity. Health factors, including skin cancer history, also influenced decision-making. Priming with consideration of objective health factors can increase the desire to pursue testing. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  4. Taxanes: vesicants, irritants, or just irritating?

    PubMed

    Barbee, Meagan S; Owonikoko, Taofeek K; Harvey, R Donald

    2014-01-01

    Several classes of antineoplastic agents are universally referred to as vesicants with ample supporting literature. However, the literature surrounding the taxanes is controversial. While the American Society of Clinical Oncology and Oncology Nursing Society Chemotherapy Administration Safety Standards and the Chemotherapy and Biotherapy Guidelines and Recommendations for Practice identify the risks of extravasation and the parameters surrounding the infusion of known vesicants, recommend administration sites for known agents, and recommend antidotes for particular extravasation cases, they fail to provide specific recommendations for the administration of individual taxanes, or a classification system for antineoplastic agents as vesicants, irritants, or inert compounds. There is also a lack of prescribing information regarding such recommendations. The lack of a formal classification system further complicates the accurate delineation of vesicant antineoplastic agents and subsequent appropriate intravenous administration and extravasation management. There are several factors that make the classification of taxanes as vesicants or irritants challenging. Comprehensive preclinical data describing potential mechanisms of tissue damage or vesicant-like properties are lacking. Furthermore, most case reports of taxane extravasation fail to include the parameters surrounding administration, such as the concentration of medication and duration of infusion, making it difficult to set parameters for vesicant potential. Subsequently, many practitioners default to central venous administration of taxanes without evidence that such administration minimizes the risk of extravasation or improves outcomes thereof. Here, we review briefly the data surrounding taxane extravasation and potential vesicant or irritant properties, classify the taxanes, and propose a spectrum for antineoplastic agent potential to cause tissue injury that warrants clinical intervention if extravasation

  5. Irritancy and Allergic Responses Induced by Topical Application of ortho-Phthalaldehyde

    PubMed Central

    Anderson, Stacey E.; Umbright, Christina; Sellamuthu, Rajendran; Fluharty, Kara; Kashon, Michael; Franko, Jennifer; Jackson, Laurel G.; Johnson, Victor J.; Joseph, Pius

    2010-01-01

    Although ortho-phthalaldehyde (OPA) has been suggested as an alternative to glutaraldehyde for the sterilization and disinfection of hospital equipment, the toxicity has not been thoroughly investigated. The purpose of these studies was to evaluate the irritancy and sensitization potential of OPA. The EpiDerm Skin Irritation Test was used to evaluate in vitro irritancy potential of OPA and glutaraldehyde. Treatment with 0.4125 and 0.55% OPA induced irritation, while glutaraldehyde exposure at these concentrations did not. Consistent with the in vitro results, OPA induced irritancy, evaluated by ear swelling, when mice were treated with 0.75%. Initial evaluation of the sensitization potential was conducted using the local lymph node assay at concentrations ranging from 0.005 to 0.75%. A concentration-dependent increase in lymphocyte proliferation was observed with a calculated EC3 value of 0.051% compared to that of 0.089%, previously determined for glutaraldehyde. Immunoglobulin (Ig) E-inducing potential was evaluated by phenotypic analysis of draining lymph node (DLN) cells and measurement of total and specific serum IgE levels. The 0.1 and 0.75% exposed groups yielded significant increases in the IgE+B220+ cell population in the lymph nodes while the 0.75% treated group demonstrated significant increases in total IgE, OPA-specific IgE, and OPA-specific IgG1. In addition, significant increases in interleukin-4 messenger RNA and protein expression in the DLNs were observed in OPA-treated groups. The results demonstrate the dermal irritancy and allergic potential of OPA and raise concern about the proposed/intended use of OPA as a safe alternative to glutaraldehyde. PMID:20176622

  6. Skin Testing With Water Buffalo's Milk in Children With Cow's Milk Allergy.

    PubMed

    Sheehan, William J; Gardynski, Andrea; Phipatanakul, Wanda

    2009-09-01

    BACKGROUND: Cow's milk allergy is the most common food allergy in young children. In areas outside the United States, milk from other mammals has been studied as a possible and desirable alternative for children with cow's milk allergy. OBJECTIVES: We chose to further investigate water buffalo's milk as an alternative for cow's milk allergic children in the United States. METHODS: Children with cow's milk allergy were skin prick tested with water buffalo's milk. Additionally, subjects were followed clinically for 1 year after the test to determine how many of the subjects had persistent cow's milk allergy. RESULTS: In total, 30 children, age 8 months to 8 years, were skin prick tested to water buffalo's milk with 73% (22/30) having a positive test. All children with a negative water buffalo's milk skin test also had a negative cow's milk skin test. In follow-up, most (7 of 8) of the children with a negative skin prick test (SPT) to water buffalo's milk were found to have outgrown their cow's milk allergy. In comparison, all of the subjects with a positive skin test to water buffalo's milk had persistent cow's milk allergy. After adjusting for this, we determined that 96% (22/23) of the children with persistent cow's milk allergy were positive on skin testing to water buffalo's milk. CONCLUSIONS: In this population, the vast majority of children with persistent cow's milk allergy were positive on skin prick testing to water buffalo's milk. These results indicate that water buffalo's milk is unlikely to be a successful alternative for children with cow's milk allergy.

  7. Effect of fructose-reduced diet in patients with irritable bowel syndrome, and its correlation to a standard fructose breath test.

    PubMed

    Berg, Leif Kyrre; Fagerli, Erik; Martinussen, Marit; Myhre, Arnt-Otto; Florholmen, Jon; Goll, Rasmus

    2013-08-01

    To perform a validation of dairy registrations for use as diagnostic tool in IBS and fructose malabsorption (FM). To investigate the precision of the fructose breath test (FBT) as compared with symptom score reduction on fructose-reduced diet (FRD) in a cohort of patients with Rome II defined irritable bowel syndrome (IBS). IBS patients diagnosed according to the Rome II criteria and with no organic gastrointestinal disease were enrolled. The patients were randomized in an open study design with a 2 week run-in on IBS diet, followed by 4 weeks w/wo additional FRD. FBT was performed in all patients. Dairy registrations of stool frequency and consistency as well as abdominal pain/discomfort and bloating on a visual analog scale (VAS) were performed during the whole study. A total of 182 subjects performed the study according to protocol (88 FRD, 94 controls). The VAS symptom registration performed well in validation procedures, whereas stool data showed less impressive characteristics. FRD improved symptom scores (abdominal pain/discomfort and bloating) significantly whereas no changes were observed in the control group. The effect of FRD on the stool frequency was modest but no effect was observed on the stool consistency. The FBT did not discriminate between patients with and without effect of FRD, and even in the group with a negative FBT significant improvement of symptom scores was observed. VAS measures yield reliable symptom evaluation in dairy registrations of IBS. FRD improves symptom scores in IBS patients independent of results from the FBT.

  8. Predictive value of the cow's milk skin prick test in infantile colic.

    PubMed

    Moravej, Hossein; Imanieh, Mohammad H; Kashef, Sara; Handjani, Farhad; Eghterdari, Fardin

    2010-01-01

    Infantile colic is a common problem among young infants. Cow's milk allergy has been suggested as one of the causes. We aimed to investigate the value of the cow's milk skin test for the diagnosis of cow's milk allergy in exclusively breast-fed infants with infantile colic. Exclusively breast-fed infants with infantile colic were enrolled in this study. On the first visit, the average hours of crying of the infant in a 24-h period were recorded and the cow's milk skin test was performed. If the infant had a positive skin test, elimination of cow's milk from the mothers' diet was advised. Infants with negative skin tests were divided into case and control groups. Cow's milk was eliminated from the diet of mothers in the case group. After 2 weeks, the number of hours of crying were recorded again. The reduction in the crying hours was compared between the two groups using the chi-square test. Skin tests were positive in 3 of 114 cases (2.6%) of infantile colic. All three cases recovered completely following elimination of cow's milk from the mother's diet. Among the 111 patients with negative skin tests, 77 patients completed the study: 35 in the case group and 42 in the control group. The reduction in crying hours in infants in the case group was not significantly different from that in the control group. Elimination of cow's milk from the mothers' diet is not beneficial for infants with a negative skin test. Infants with a positive skin test may benefit from this management.

  9. Tuberculin skin test conversion among health sciences students: A retrospective cohort study

    PubMed Central

    Pérez-Lu, José E.; Cárcamo, Cesar P.; García, Patricia J.; Bussalleu, Alejandro; Bernabé-Ortiz, Antonio

    2014-01-01

    SUMMARY Previous studies have reported that health sciences students are at greater risk for tuberculosis infection, especially in developing countries. The objective of this study was to estimate the prevalence, incidence, and factors associated with latent tuberculosis infection among Health Sciences students in Peru. Students enrolled at private university (in Lima – Peru) are tested annually for tuberculosis infection by tuberculin skin test. Data on tuberculin skin test results between 2002 and 2009 was used in this retrospective cohort study, a total of 4842 students were included. Tuberculin skin test conversion was defined as the change of tuberculin skin test from negative (<10 mm) to positive (≥10 mm) after 48 –72 h of inoculation. Baseline tuberculin skin test positivity was 1.0% (95%CI: 0.6%–1.3%), whereas tuberculin skin test conversion incidence was 12.4 per 100 person-years (95%CI: 11.8–13.0). This study showed that students from clinical careers in close contact with patients had an increased risk of tuberculosis infection in the internship, especially Medicine, Dentistry, Medical Technology and Nursing. Administrative, environmental and personal protection measures should be implemented and evaluated periodically in order to reduce the risk of exposure. PMID:23116653

  10. New strategy to improve quality control of Montenegro skin test at the production level.

    PubMed

    Guedes, Deborah Carbonera; Minozzo, João Carlos; Pasquali, Aline Kuhn Sbruzzi; Faulds, Craig; Soccol, Carlos Ricardo; Thomaz-Soccol, Vanete

    2017-01-01

    The production of the Montenegro antigen for skin test poses difficulties regarding quality control. Here, we propose that certain animal models reproducing a similar immune response to humans may be used in the quality control of Montenegro antigen production. Fifteen Cavia porcellus (guinea pigs) were immunized with Leishmania amazonensis or Leishmania braziliensis , and, after 30 days, they were skin tested with standard Montenegro antigen. To validate C. porcellus as an animal model for skin tests, eighteen Mesocricetus auratus (hamsters) were infected with L. amazonensis or L. braziliensis , and, after 45 days, they were skin tested with standard Montenegro antigen. Cavia porcellus immunized with L. amazonensis or L. braziliensis , and hamsters infected with the same species presented induration reactions when skin tested with standard Montenegro antigen 48-72h after the test. The comparison between immunization methods and immune response from the two animal species validated C. porcellus as a good model for Montenegro skin test, and the model showed strong potential as an in vivo model in the quality control of the production of Montenegro antigen.

  11. Dual skin tests with Mycobacterium avium sensitin and PPD to detect misdiagnosis of latent tuberculosis infection.

    PubMed

    Larson, E M; O'Donnell, M; Chamblee, S; Horsburgh, C R; Marsh, B J; Moreland, J D; Johnson, L S; von Reyn, C Fordham

    2011-11-01

    A positive tuberculin skin test (TST) may indicate cross-reacting immunity to non-tuberculous mycobacteria (NTM) and not latent tuberculosis infection (LTBI). To assess misclassification of LTBI, as assessed by skin testing with Mycobacterium avium sensitin (MaS), and to determine how this misclassification affects the analysis of risk factors for LTBI. In a population-based survey, participants underwent skin testing with M. tuberculosis purified protein derivative (PPD) and MaS. A PPD-dominant skin test was a reaction that was ≥ 3 mm larger than the MaS reaction; a MaS-dominant skin test was a reaction that was ≥ 3 mm larger than the PPD reaction. Of 447 randomly selected persons, 135 (30%) had a positive PPD test. Of these, 21 (16%) were MaS- dominant, and were therefore attributable to NTM and misclassified as LTBI. PPD reactions of 5-14 mm were more likely to be misclassified than those ≥ 15 mm (OR = 5.0, 95%CI 1.9-13.2). Adjusting for misclassification had only a small impact on the analysis of risk factors for LTBI. A substantial number of individuals who are diagnosed with LTBI are actually sensitized to NTM. Using dual skin testing would reduce misdiagnosis and prevent unnecessary treatment.

  12. Skin test reactivity to female sex hormones in women with primary unexplained recurrent pregnancy loss.

    PubMed

    Ellaithy, Mohamed I; Fathi, Hesham M; Farres, Mohamed N; Taha, Marwa S

    2013-09-01

    The objective was to examine the hypothesis that primary unexplained recurrent pregnancy loss might be associated with an inappropriate immunologically mediated response to progesterone and/or estrogen. This prospective study included 47 women with two or more documented consecutive early pregnancy losses of unknown etiology, and no previous history of deliveries. Intradermal skin testing was performed in the luteal phase of the cycle (days 16-20) using estradiol benzoate, progesterone, and a placebo of refined sesame oil. Immediate (20 min) and late (24h and 1 week) skin test readings for all cases were compared with those of 12 parous women of comparable age with no history of spontaneous miscarriages, premenstrual disorders, pregnancy, or sex hormone-related allergic or autoimmune diseases. Main outcome measure was skin test reactivity to estradiol and/or progesterone. Immediate skin test reactivity to both hormones was observed among half of the cases at 20 min. A papule after 24h, which persisted for up to 1 week, was observed among 32 (68.1%) and 34 (72.3%) cases at the sites of estrogen and progesterone injection, respectively. 55.3% of cases had combined skin test reactivity to both estradiol and progesterone at 1 week. All women in the control group showed absence of skin test reactivity for both estradiol and progesterone at 20 min, 24h, and 1 week. None of the subjects in either group showed skin test reactivity to placebo. There is an association between primary unexplained recurrent pregnancy loss and skin test reactivity to female sex hormones. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  13. CAT SCRATCH DISEASE: RESULTS OF COMPLEMENT-FIXATION AND SKIN TESTS

    DTIC Science & Technology

    Serologic and skin-testing data on a group of patients having cat scratch disease are presented to demonstrate a possible relationship to the psitt...indicate that the incidence of positive serologic reactions with the psitt-LGV group antigen is consistently higher in patients with cat scratch disease...patients, 2 of 5 did not respond with positive skin reactions when tested with cat scratch antigen, and at least 2 of the remaining 3 responded in a manner difficult to interpret.

  14. [Practice patterns in Mexican allergologists about skin tests with allergens during 2005-2006].

    PubMed

    Larenas Linnemann, Désirée; Fogelbach, Guillermo Arturo Guidos; Cruz, Alfredo Arias

    2008-01-01

    Immunotherapy has been practiced since over a hundred years. The exact composition of the immunotherapy concentrate, with which the patient is treated, depends partly on the results of the skin prick tests applied to the allergic patient. As such, the effectiveness of the immunotherapy depends heavily on the quality of the skin prick test. The detailed recommendations for the realization of the skin prick tests have evolved and changed over the years, leading to multiple variations in its application in Mexico. We tried to get a picture of the daily practice patterns of the members of CMICA and CoMPedIA concerning the application of skin prick tests. Aquestionnaire was sent in various occasions to all members of the Colegio Mexicano de Inmunologia Clinica y Alergia (CMICA) and of the Colegio Mexicano de Pediatras, Especialistas en Inmunologia y Alergia (CoMPedIA). The results are presented descriptively and by calculation of the frequency/percentages of intervals of replies, in the case of numerical responses. A response rate of 61 (17%) was obtained of the College members, showing consistency in some replies but a wide variation in others, for example in the time certain medication has to be suspended before the execution of the skin prick test. Comparing the replies obtained with recent recommendations in international publications, some discrepancy can be detected. In some aspects of the survey there is coincidence of the skin test practices among the participants; however, in other items there is an important variation.

  15. A reassessment of the in vitro RBC haemolysis assay with defibrinated sheep blood for the determination of the ocular irritation potential of cosmetic products: comparison with the in vivo Draize rabbit test.

    PubMed

    Alves, Eloísa Nunes; Presgrave, Rosaura de Farias; Presgrave, Octávio Augusto França; Sabagh, Fernanda Peres; de Freitas, João Carlos Borges Rolim; Corrado, Alexandre P

    2008-07-01

    We examined the correlation between results obtained from the in vivo Draize test for ocular irritation and in vitro results obtained from the sheep red blood cell (RBC) haemolytic assay, which assesses haemolysis and protein denaturation in erythrocytes, induced by cosmetic products. We sought to validate the haemolytic assay as a preliminary test for identifying highly-irritative products, and also to evaluate the in vitro test as alternative assay for replacement of the in vivo test. In vitro and in vivo analyses were carried out on 19 cosmetic products, in order to correlate the lesions in the ocular structures with three in vitro parameters: (i) the extent of haemolysis (H50); (ii) the protein denaturation index (DI); and (iii) the H50/DI ratio, which reflects the irritation potential (IP). There was significant correlation between maximum average scores (MAS) and the parameters determined in vitro (r = 0.752-0.764). These results indicate that the RBC assay is a useful and rapid test for use as a screening method to assess the IP of cosmetic products, and for predicting the IP value with a high level of concordance (94.7%). The assay showed high sensitivity and specificity rates of 91.6% and 100%, respectively.

  16. Correcting for possible tissue distortion between provocation and assessment in skin testing: the divergent beam UVB photo-test.

    PubMed

    O'Doherty, Jim; Henricson, Joakim; Falk, Magnus; Anderson, Chris D

    2013-11-01

    In tissue viability imaging (TiVi), an assessment method for skin erythema, correct orientation of skin position from provocation to assessment optimizes data interpretation. Image processing algorithms could compensate for the effects of skin translation, torsion and rotation realigning assessment images to the position of the skin at provocation. A reference image of a divergent, UVB phototest was acquired, as well as test images at varying levels of translation, rotation and torsion. Using 12 skin markers, an algorithm was applied to restore the distorted test images to the reference image. The algorithm corrected torsion and rotation up to approximately 35 degrees. The radius of the erythemal reaction and average value of the input image closely matched that of the reference image's 'true value'. The image 'de-warping' procedure improves the robustness of the response image evaluation in a clinical research setting and opens the possibility of the correction of possibly flawed images performed away from the laboratory setting by the subject/patient themselves. This opportunity may increase the use of photo-testing and, by extension, other late response skin testing where the necessity of a return assessment visit is a disincentive to performance of the test. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. Skin age testing criteria: characterization of human skin structures by 500 MHz MRI multiple contrast and image processing.

    PubMed

    Sharma, Rakesh

    2010-07-21

    Ex vivo magnetic resonance microimaging (MRM) image characteristics are reported in human skin samples in different age groups. Human excised skin samples were imaged using a custom coil placed inside a 500 MHz NMR imager for high-resolution microimaging. Skin MRI images were processed for characterization of different skin structures. Contiguous cross-sectional T1-weighted 3D spin echo MRI, T2-weighted 3D spin echo MRI and proton density images were compared with skin histopathology and NMR peaks. In all skin specimens, epidermis and dermis thickening and hair follicle size were measured using MRM. Optimized parameters TE and TR and multicontrast enhancement generated better MRI visibility of different skin components. Within high MR signal regions near to the custom coil, MRI images with short echo time were comparable with digitized histological sections for skin structures of the epidermis, dermis and hair follicles in 6 (67%) of the nine specimens. Skin % tissue composition, measurement of the epidermis, dermis, sebaceous gland and hair follicle size, and skin NMR peaks were signatures of skin type. The image processing determined the dimensionality of skin tissue components and skin typing. The ex vivo MRI images and histopathology of the skin may be used to measure the skin structure and skin NMR peaks with image processing may be a tool for determining skin typing and skin composition.

  18. Skin age testing criteria: characterization of human skin structures by 500 MHz MRI multiple contrast and image processing

    NASA Astrophysics Data System (ADS)

    Sharma, Rakesh

    2010-07-01

    Ex vivo magnetic resonance microimaging (MRM) image characteristics are reported in human skin samples in different age groups. Human excised skin samples were imaged using a custom coil placed inside a 500 MHz NMR imager for high-resolution microimaging. Skin MRI images were processed for characterization of different skin structures. Contiguous cross-sectional T1-weighted 3D spin echo MRI, T2-weighted 3D spin echo MRI and proton density images were compared with skin histopathology and NMR peaks. In all skin specimens, epidermis and dermis thickening and hair follicle size were measured using MRM. Optimized parameters TE and TR and multicontrast enhancement generated better MRI visibility of different skin components. Within high MR signal regions near to the custom coil, MRI images with short echo time were comparable with digitized histological sections for skin structures of the epidermis, dermis and hair follicles in 6 (67%) of the nine specimens. Skin % tissue composition, measurement of the epidermis, dermis, sebaceous gland and hair follicle size, and skin NMR peaks were signatures of skin type. The image processing determined the dimensionality of skin tissue components and skin typing. The ex vivo MRI images and histopathology of the skin may be used to measure the skin structure and skin NMR peaks with image processing may be a tool for determining skin typing and skin composition.

  19. The Yucatan miniature swine as an in vivo model for screening skin depigmentation.

    PubMed

    Nair, X; Tramposch, K M

    1991-12-01

    The usefulness of the Yucatan miniature pig as a screen for skin dipigmenting activity by topical application was evaluated with standard compounds. This is a naturally occurring breed of swine with light brown to dark brown skin that is relatively hairless. The skin morphology, including the pattern of pigment distribution, in this breed of swine closely resembles the human skin. Test compounds examined in this study included the three standard compounds with known clinical depigmenting activity, hydroquinone (HQ), 4-hydroxyanisole (4HA) and tert-butyl catechol (TBC), each at a 5% concentration. Test materials in 25 microliters of propylene glycol/ethanol (50:50) were applied topically twice daily, 7 days a week for 90 days to test sites on each side of the dorsal mid-line. Test sites were graded weekly for variation in pigmentation and local irritation. After 90 days of test material application, skin biopsies of the test sites were taken for histological evaluation. Topical application of HQ, 4HA and TBC promoted marked skin depigmentation which was substantiated by reductions of pigment and melanocytes observed on microscopic examination. While both HQ and TBC produced marked local irritation, 4HA was only mildly irritating. These results suggest that the Yucatan pig, could be a potentially useful model for screening compounds with skin depigmenting activity.

  20. Utility of minor determinants for skin testing in inpatient penicillin allergy evaluation.

    PubMed

    Geng, Bob; Eastman, Jacqueline J; Mori, Karen; Braskett, Melinda; Riedl, Marc A

    2017-09-01

    Most patients with a history of penicillin allergy can tolerate penicillin. Skin testing can identify tolerant patients, but not all known allergenic determinants are commercially available. Protocols exist that use only available reagents, but the sensitivity and safety of these protocols, particularly for hospitalized patients, are controversial. To determine the number of hospitalized patients referred for penicillin skin testing who showed unique positivity to the minor determinants penicilloate and penilloate. A retrospective chart review was conducted of all inpatients who underwent penicillin skin testing at 1 institution. Patients were referred by their treating physician. All patients underwent skin prick testing to benzylpenicilloyl polylysine (major determinant), penicillin G, penicilloate, penilloate (minor determinants), amoxicillin, and positive and negative controls. If the result was negative, then intradermal testing was done with the same penicillin determinants and the negative control. A 4-mm wheal with flare was considered a positive reaction. Inpatient penicillin skin testing was done in 528 subjects. Any positive test reaction was found in 107 subjects (20%). Three subjects (3%) reacted to penilloate only, 25 (23%) reacted to penicilloate only, 2 (2%) reacted to penicillin G only, and 8 (8%) reacted to amoxicillin only. Sixty-eight subjects (64%) reacted to a compound other than the major determinant. This study found a high rate of exclusively positive skin test reactions to the minor determinants penicilloate and penilloate. Because patients with positive test reactions are at increased risk of reaction to drug challenge, these data support the use of these reagents for penicillin skin testing in hospitalized patients. Copyright © 2017 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  1. Penicillin skin testing is a safe and effective tool for evaluating penicillin allergy in the pediatric population.

    PubMed

    Fox, Stephanie J; Park, Miguel A

    2014-01-01

    Penicillin skin testing has been validated in the evaluation of adult patients with penicillin allergy. However, the commercially available benzylpenicilloyl polylysine (Pre-Pen) is not indicated in the pediatric population. Moreover, the safety and validity of penicillin skin testing in the pediatric population has not been well studied. We describe the safety and validity of penicillin skin testing in the evaluation of children with a history of penicillin allergy. Children (<18 years) with a history of penicillin allergy were evaluated with penicillin skin tests and were reviewed for basic demographics, penicillin skin test results, adverse drug reaction to penicillin after penicillin skin test, and adverse reaction to penicillin skin test. By using the χ(2) test, we compared the differences in the proportion of children and adults with a positive penicillin skin test. P value (<.05) was considered statistically significant. The institutional review board approved the study, and all the subjects signed written informed consents. A total of 778 children underwent penicillin skin testing; 703 of 778 patients had a negative penicillin skin test (90.4%), 66 had a positive test (8.5%), and 9 had an equivocal test (1.1%). Children were more likely to have a positive penicillin skin test (P < .0001) compared with adults (64 of 1759 [3.6%]); 369 of 703 patients with negative penicillin skin test (52%) were challenged with penicillin, and 14 of 369 patients (3.8%) had an adverse drug reaction. No adverse reactions to penicillin skin testing were observed. Penicillin skin testing was safe and effective in the evaluation of children with a history of penicillin allergy. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  2. Beneficial effects of softened fabrics on atopic skin.

    PubMed

    Hermanns, J F; Goffin, V; Arrese, J E; Rodriguez, C; Piérard, G E

    2001-01-01

    There is general concern about the possible cutaneous adverse effects of wearing garments treated with household laundry products, particularly on atopic skin. Our objective was to compare softened and non- softened fabrics in a forearm wet and dry test, under conditions simulating real-life conditions. Twenty atopic volunteers entered a single-blind 12-day (3 sessions per day) forearm wetting and drying test. Cotton fabrics were machine washed and liquid fabric conditioner was added or not to the final rinse. To simulate conditions of skin damage, a dilute solution of sodium lauryl sulphate was applied under occlusion to the forearm of each volunteer before the start of the study. Skin effects were evaluated by visual grading (redness, dryness and smoothness), squamometry and in vivo instrumental measurements (capacitance, transepidermal water loss and colorimetry). Rubbing of atopic skin with fabrics generally resulted in discrete to moderate alterations of the structure of the stratum corneum. Both for control and pre-irritated skin, all measured parameters indicated that softened fabric was less aggressive to the skin than unsoftened fabric. In the case of pre-irritated skin, the recovery of the skin was significantly faster when rubbed with softened than with unsoftened fabrics. In conclusion, softened fabrics help mitigate the skin condition in atopic patients. Copyright 2001 S. Karger AG, Basel.

  3. The hen's egg chorioallantoic membrane (HET-CAM) test to predict the ophthalmic irritation potential of a cysteamine-containing gel: Quantification using Photoshop® and ImageJ.

    PubMed

    McKenzie, Barbara; Kay, Graeme; Matthews, Kerr H; Knott, Rachel M; Cairns, Donald

    2015-07-25

    A modified hen's egg chorioallantoic membrane (HET-CAM) test has been developed, combining ImageJ analysis with Adobe(®) Photoshop(®). The irritation potential of an ophthalmic medicine can be quantified using this method, by monitoring damage to blood vessels. The evaluation of cysteamine containing hyaluronate gel is reported. The results demonstrated that the novel gel formulation is non-irritant to the ocular tissues, in line with saline solution (negative control). In conclusion, the modification of the established HET-CAM test can quantify the damage to minute blood vessels. These results offer the possibility to formulate cysteamine in an ocular applicable gel formulation. Copyright © 2015 Elsevier B.V. All rights reserved.

  4. Systematic evaluation of non-animal test methods for skin sensitisation safety assessment.

    PubMed

    Reisinger, Kerstin; Hoffmann, Sebastian; Alépée, Nathalie; Ashikaga, Takao; Barroso, Joao; Elcombe, Cliff; Gellatly, Nicola; Galbiati, Valentina; Gibbs, Susan; Groux, Hervé; Hibatallah, Jalila; Keller, Donald; Kern, Petra; Klaric, Martina; Kolle, Susanne; Kuehnl, Jochen; Lambrechts, Nathalie; Lindstedt, Malin; Millet, Marion; Martinozzi-Teissier, Silvia; Natsch, Andreas; Petersohn, Dirk; Pike, Ian; Sakaguchi, Hitoshi; Schepky, Andreas; Tailhardat, Magalie; Templier, Marie; van Vliet, Erwin; Maxwell, Gavin

    2015-02-01

    The need for non-animal data to assess skin sensitisation properties of substances, especially cosmetics ingredients, has spawned the development of many in vitro methods. As it is widely believed that no single method can provide a solution, the Cosmetics Europe Skin Tolerance Task Force has defined a three-phase framework for the development of a non-animal testing strategy for skin sensitization potency prediction. The results of the first phase – systematic evaluation of 16 test methods – are presented here. This evaluation involved generation of data on a common set of ten substances in all methods and systematic collation of information including the level of standardisation, existing test data,potential for throughput, transferability and accessibility in cooperation with the test method developers.A workshop was held with the test method developers to review the outcome of this evaluation and to discuss the results. The evaluation informed the prioritisation of test methods for the next phase of the non-animal testing strategy development framework. Ultimately, the testing strategy – combined with bioavailability and skin metabolism data and exposure consideration – is envisaged to allow establishment of a data integration approach for skin sensitisation safety assessment of cosmetic ingredients.

  5. [Hypersensitivity to platinum salts and taxanes: The value of skin tests and tolerance induction procedures].

    PubMed

    Brault, F; Waton, J; Poreaux, C; Schmutz, J-L; Barbaud, A

    2017-11-01

    The rate of hypersensitivity reactions to platinum salts (PS) and taxanes (TX) is on the increase. The aim of our study was to show the value of skin testing and efficacy of rapid drug desensitization. This was a retrospective study conducted between January 2007 and February 2016 in patients consulting for immediate or delayed hypersensitivity to PS and TX. Skin prick tests (pT) and intradermal reaction tests (IDR) were performed according to the ENDA/EAACI recommendations. We used a 12-step desensitization protocol for rapid drug desensitization. Among the 99 patients included (30 men, 69 women, age 60.4) PS were suspected in 86 cases and taxanes in 13 cases. Skin tests were positive in 25 patients (7 pT, 18 IDR), 23 for platinum salts and 2 for taxanes. Rapid drug desensitization was proposed in 50 patients and performed in 33 (30 PS and 3 TX), proved effective in 29 patients, with protocol adaptation being necessary in 7 cases, and was ineffective in 4 patients. The skin tests for the latter 4 patients were positive. Seventy-five percent of patients with positive skin tests to oxaliplatin presented hypersensitivity reactions during desensitization, i.e. twice as many as patients having negative skin tests. Two percent of patient for PS and 7% for TX had cross reactivity. This French study confirms the efficacy of the 12-step protocol that allows patients to receive chemotherapy after hypersensitivity reaction. Skin test permits the detection of cross-reactions but their practice must be considered based on the patient's history. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  6. Sensitive skin and stratum corneum reactivity to household cleaning products.

    PubMed

    Goffin, V; Piérard-Franchimont, C; Piérard, G E

    1996-02-01

    Products intended for individuals with sensitive skin are being increasingly developed by formulators of household cleaning products. However, there is currently no consensus about the definition and recognition of the biological basis of sensitive skin. We sought to determine the relation between the nature of environmental threat perceived as aggressive by panelists, and the stratum corneum reactivity to household cleaning products as measured by the corneosurfametry test. Results indicate substantial differences in irritancy potential between proprietary products. Corneosurfametry data show significant differences in stratum corneum reactivity between, on the one hand, individuals with either non-sensitive skin or skin sensitive to climate/fabrics, and, on the other hand, individuals with detergent-sensitive skin. It is concluded that sensitive skin is not one single condition. Sound information in rating detergent-sensitive skin may be gained by corneosurfametry.

  7. Use of recombinant purified protein derivative (PPD) antigens as specific skin test for tuberculosis.

    PubMed

    Stavri, Henriette; Bucurenci, Nadia; Ulea, Irina; Costache, Adriana; Popa, Loredana; Popa, Mircea Ioan

    2012-11-01

    Purified protein derivative (PPD) is currently the only available skin test reagent used worldwide for the diagnosis of tuberculosis (TB). The aim of this study was to develop a Mycobacterium tuberculosis specific skin test reagent, without false positive results due to Bacillus Calmette-Guerin (BCG) vaccination using recombinant antigens. Proteins in PPD IC-65 were analyzed by tandem mass spectrometry and compared to proteins in M. tuberculosis culture filtrate; 54 proteins were found in common. Top candidates MPT64, ESAT 6, and CFP 10 were overexpressed in Escherichia coli expression strains and purified as recombinant proteins. To formulate optimal immunodiagnostic PPD cocktails, the antigens were evaluated by skin testing guinea pigs sensitized with M. tuberculosis H37Rv and BCG. For single antigens and a cocktail mixture of these antigens, best results were obtained using 3 μg/0.1 ml, equivalent to 105 TU (tuberculin units). Each animal was simultaneously tested with PPD IC-65, 2 TU/0.1 ml, as reference. Reactivity of the multi-antigen cocktail was greater than that of any single antigen. The skin test results were between 34.3 and 76.6 per cent the level of reactivity compared to that of the reference when single antigens were tested and 124 per cent the level of reactivity compared to the reference for the multi-antigen cocktail. Our results showed that this specific cocktail could represent a potential candidate for a new skin diagnostic test for TB.

  8. Integrating non-animal test information into an adaptive testing strategy - skin sensitization proof of concept case.

    PubMed

    Jaworska, Joanna; Harol, Artsiom; Kern, Petra S; Gerberick, G Frank

    2011-01-01

    There is an urgent need to develop data integration and testing strategy frameworks allowing interpretation of results from animal alternative test batteries. To this end, we developed a Bayesian Network Integrated Testing Strategy (BN ITS) with the goal to estimate skin sensitization hazard as a test case of previously developed concepts (Jaworska et al., 2010). The BN ITS combines in silico, in chemico, and in vitro data related to skin penetration, peptide reactivity, and dendritic cell activation, and guides testing strategy by Value of Information (VoI). The approach offers novel insights into testing strategies: there is no one best testing strategy, but the optimal sequence of tests depends on information at hand, and is chemical-specific. Thus, a single generic set of tests as a replacement strategy is unlikely to be most effective. BN ITS offers the possibility of evaluating the impact of generating additional data on the target information uncertainty reduction before testing is commenced.

  9. Yield of diagnostic tests for celiac disease in individuals with symptoms suggestive of irritable bowel syndrome: systematic review and meta-analysis.

    PubMed

    Ford, Alexander C; Chey, William D; Talley, Nicholas J; Malhotra, Ashish; Spiegel, Brennan M R; Moayyedi, Paul

    2009-04-13

    Individuals with irritable bowel syndrome (IBS) report abdominal pain, bloating, and diarrhea, symptoms similar to those in celiac disease. Studies suggest that the prevalence of celiac disease is increased in individuals with IBS; however, evidence is conflicting, and current guidelines do not always recommend screening for celiac disease in these individuals. We conducted a systematic review and meta-analysis to estimate prevalence of celiac disease in unselected adults who met diagnostic criteria for IBS. MEDLINE (1950 to May 31, 2008) and EMBASE (1980 to May 31, 2008) were searched. Case series and case-control studies that used serologic tests for celiac disease were eligible for inclusion. Prevalence of positive serologic indications of celiac disease and biopsy-proved celiac disease were extracted and pooled for all studies and were compared between cases and controls using an odds ratio and 95% confidence interval. Fourteen studies were identified comprising 4204 individuals, of whom 2278 (54%) met diagnostic criteria for IBS. Pooled prevalence of positive IgA-class antigliadin antibodies, either positive endomysial antibodies or tissue transglutaminase, and biopsy-proved celiac disease were 4.0% (95% confidence interval, 1.7-7.2), 1.63% (0.7-3.0), and 4.1% (1.9-7.0), respectively. Pooled odds ratios (95% confidence intervals) for positive IgA-class antigliadin antibodies, either positive endomysial antibodies or tissue transglutaminase, and biopsy-proved celiac disease in cases meeting diagnostic criteria for IBS compared with controls without IBS were 3.40 (1.62-7.13), 2.94 (1.36-6.35), and 4.34 (1.78-10.6). Prevalence of biopsy-proved celiac disease in cases meeting diagnostic criteria for IBS was more than 4-fold that in controls without IBS.

  10. Development, validation and testing of a skin sampling method for assessment of metal exposure.

    PubMed

    Erfani, Behnaz; Midander, Klara; Lidén, Carola; Julander, Anneli

    2017-07-01

    Nickel, cobalt and chromium are frequent skin sensitizers. Skin exposure results in eczema in sensitized individuals, the risk being related to the skin dose. To develop a self-sampling method for quantification of skin exposure to metals, to validate the method, and to assess its feasibility. Defined metal doses (0.01-5 µg) were applied to the fingers of 5 participants. Skin areas (2 cm 2 ) were sampled with 1% HNO 3 , either as 0.1 ml on a swab, or as 0.5 ml on a wipe. Furthermore, 17 participants performed self-sampling by swab after 2 h of leisure activity. Samples were extracted in 1% HNO 3 and analysed by inductively coupled plasma mass spectrometry. The sampling efficiency by swab was 46%, as compared with 93% for acid wipe sampling, for all tested doses. Most metal from the skin dose was detected in the first swab (33-43%). Despite lower sampling efficiency by swab, skin doses of metals following 2 h of leisure activity without hand washing were quantified in all participants, and ranged from 0.0016 to 0.15 µg/cm 2 , from 0.00014 to -0.0020 µg/cm 2 and from 0.00048 to -0.027 µg/cm 2 for nickel, cobalt, and chromium, respectively. The results indicate a future potential of skin sampling by swab to detect and monitor metals on skin by self-sampling. This will contribute to better knowledge of metal skin exposure among dermatitis patients, workers, and the general population. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. The use of ex vivo human skin tissue for genotoxicity testing

    SciTech Connect

    Reus, Astrid A.; Usta, Mustafa; Krul, Cyrille A.M., E-mail: cyrille.krul@tno.nl

    2012-06-01

    As a result of the chemical legislation concerning the registration, evaluation, authorization and restriction of chemicals (REACH), and the Seventh Amendment to the Cosmetics Directive, which prohibits animal testing in Europe for cosmetics, alternative methods for safety evaluation of chemicals are urgently needed. Current in vitro genotoxicity assays are not sufficiently predictive for the in vivo situation, resulting in an unacceptably high number of misleading positives. For many chemicals and ingredients of personal care products the skin is the first site of contact, but there are no in vitro genotoxicity assays available in the skin for additional evaluation of positivemore » or equivocal responses observed in regulatory in vitro genotoxicity assays. In the present study ex vivo human skin tissue obtained from surgery was used for genotoxicity evaluation of chemicals by using the comet assay. Fresh ex vivo human skin tissue was cultured in an air–liquid interface and topically exposed to 20 chemicals, including true positive, misleading positive and true negative genotoxins. Based on the results obtained in the present study, the sensitivity, specificity and accuracy of the ex vivo skin comet assay to predict in vivo genotoxicity were 89%, 90% and 89%, respectively. Donor and experimental variability were mainly reflected in the magnitude of the response and not the difference between the presence and absence of a genotoxic response. The present study indicates that human skin obtained from surgery is a promising and robust model for safety evaluation of chemicals that are in direct contact with the skin. -- Highlights: ► We use human skin obtained from surgery for genotoxicity evaluation of chemicals. ► We use the comet assay as parameter for genotoxicity in ex vivo human skin. ► Sensitivity, specificity and accuracy to predict in vivo genotoxins are determined. ► Sensitivity, specificity and accuracy are 89%, 90% and 90%, respectively. ► The

  12. A comparison of skin endpoint titration and skin-prick testing in the diagnosis of allergic rhinitis.

    PubMed

    Gungor, Anil; Houser, Steven M; Aquino, Benjamin F; Akbar, Imran; Moinuddin, Rizwan; Mamikoglu, Bulent; Corey, Jacquelynne P

    2004-01-01

    Among the many methods of allergy diagnosis are intradermal testing (IDT) and skin-prick testing (SPT). The usefulness of IDT has been called into question by some authors, while others believe that studies demonstrating that SPT was superior might have been subject to bias. We conducted a study to compare the validity of SPT and IDT--specifically, the skin endpoint titration (SET) type of IDT--in diagnosing allergic rhinitis. We performed nasal provocation testing on 62 patients to establish an unbiased screening criterion for study entry. Acoustic rhinometric measurements of the nasal responses revealed that 34 patients tested positive and 28 negative. All patients were subsequently tested by SET and SPT. We found that SPT was more sensitive (85.3 vs 79.4%) and more specific (78.6 vs 67.9%) than SET as a screening procedure. The positive predictive value of SPT was greater than that of SET (82.9 vs 75.0%), as was the negative predictive value (81.5 vs 73.0%). None of these differences was statistically significant; because of the relatively small sample size, our study was powered to show only equivalency. The results of our study suggest that the information obtained by the SET method of IDT is comparable to that obtained by SPT in terms of sensitivity, specificity, and overall performance and that both SET and SPT correlate well with nasal provocation testing for ragweed. Therefore, the decision as to which to use can be based on other factors, such as the practitioner's training, the desire for quantitative results, the desire for rapid results, and the type of treatment (i.e., immunotherapy or pharmacotherapy) that is likely to be chosen on the basis of test results.

  13. [Assessment of hypersensitivity to honey-bee venom in beekeepers by skin tests].

    PubMed

    Becerril-Ángeles, Martín; Núñez-Velázquez, Marco; Marín-Martínez, Javier

    2013-01-01

    Beekeepers are exposed to frequent honey-bee stings, and have the risk to develop hypersensitivity to bee venom, but long-term exposure can induce immune tolerance in them. Up to 30% of beekeepers show positive skin tests with honey-bee venom. The prevalence of systemic reactions to bee stings in beekeepers is from 14% to 42%. To know the prevalence of hypersensitivity to honeybee venom in Mexican beekeepers and non-beekeepers by the use of skin tests. A group of 139 beekeepers and a group of 60 non-beekeeper volunteers had a history and physical related to age, sex, family and personal atopic history and time of exposure to bee stings. Both groups received intradermal skin tests with honey-bee venom, 0.1 mcg/mL and 1 mcg/mL, and histamine sulphate 0.1 mg/mL and Evans solution as controls. The skin tests results of both groups were compared by chi-squared test. Of the group of beekeepers, 116 were men (83%) and 23 women, average age was 39.3 years, had atopic family history 28% and personal atopy 13%, average time of exposure to bee stings was 10.9 years, skin tests with honey-bee venom were positive in 16.5% and 11% at 1 mcg/mL and 0.1 mcg/mL, respectively. In the non-beekeepers group venom skin tests were positive in 13.3% and 6.7% at 1 mcg/mL and 0.1 mcg/mL. We did not find significant differences between the two venom concentrations tested in both groups, neither in the number of positive skin tests between the two groups. We found hypersensivity to honey-bee venom slightly higher in the beekeepers than in the group apparently not exposed. Both honey-bee venom concentrations used did not show difference in the results of the skin tests. The similarity of skin tests positivity between both groups could be explained by immune tolerance due to continued exposure of beekeepers.

  14. Skin Diseases: Questions for Your Health Care Provider

    MedlinePlus

    Skip Navigation Bar Home Current Issue Past Issues Skin Diseases Questions for Your Health Care Provider Past ... dermatitis worse? What are the most common irritants? Skin cancer What type of skin cancer do I ...

  15. Optical coherence tomography applied to tests of skin care products in humans--a case study.

    PubMed

    Vasquez-Pinto, L M C; Maldonado, E P; Raele, M P; Amaral, M M; de Freitas, A Z

    2015-02-01

    When evaluating skin care products for human skin, quantitative test methods need to be simple, precise and reliable. Optical coherence tomography (OCT), provides high-resolution sectional images of translucent materials to a depth of a few millimeters, a technique usually applied to medical measurements in ophthalmology and dermatology. This study aimed to demonstrate the application of OCT as the main technique for monitoring changes in skin topography during tests of a wrinkle-reduction product in humans. We used a commercial OCT apparatus to perform clinical examinations of skin roughness in treated and non-treated sites in the periorbital region of thirty human voluntaries who were using an anti-aging product commercially available: Natura Chronos® Flavonóides de Passiflora 45+ FPS15, from Natura Cosméticos, Brazil. Measurements were performed days 0, 7, 14 and 28 of treatment. Equipment and software allowed real-time recording of skin roughness parameters and wrinkle depths. The OCT measurements have allowed the monitoring of changes in skin roughness, which have shown reduction in treated sites around 10%. The obtained depth distributions also indicate reduction in the occurrence of wrinkles deeper than 170 μm. The verified results are consistent with those typically obtained after successful treatment with modern anti-aging products. By using the OCT technique, it was possible to quantify changes in skin roughness and in the distribution of depths of skin wrinkles, with adequate sensitivity. OCT imaging allows the direct visualization of the skin topography with resolution of micrometers, a reliable and interactive tool for clinical use. Therefore, for the first time, we demonstrated the use of OCT technique to verify the efficacy of cosmetic products in real time. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  16. The potential utility of iodinated contrast media (ICM) skin testing in patients with ICM hypersensitivity.

    PubMed

    Ahn, Young-Hwan; Koh, Young-Il; Kim, Joo-Hee; Ban, Ga-Young; Lee, Yeon-Kyung; Hong, Ga-Na; Jin, U-Ram; Choi, Byung-Joo; Shin, Yoo-Seob; Park, Hae-Sim; Ye, Young-Min

    2015-03-01

    Both immediate and delayed hypersensitivity reactions to iodinated contrast media (ICM) are relatively common. However, there are few data to determine the clinical utility of immunologic evaluation of ICM. To evaluate the utility of ICM skin testing in patients with ICM hypersensitivity, 23 patients (17 immediate and 6 delayed reactions) were enrolled from 3 university hospitals in Korea. With 6 commonly used ICM including iopromide, iohexol, ioversol, iomeprol, iopamidol and iodixanol, skin prick (SPT), intradermal (IDT) and patch tests were performed. Of 10 patients with anaphylaxis, 3 (30.0%) and 6 (60.0%) were positive respectively on SPTs and IDTs with the culprit ICM. Three of 6 patients with urticaria showed positive IDTs. In total, 11 (64.7%) had positive on either SPT or IDT. Three of 6 patients with delayed rashes had positive response to patch test and/or delayed IDT. Among 5 patients (3 anaphylaxis, 1 urticaria and 1 delayed rash) taken subsequent radiological examinations, 3 patients administered safe alternatives according to the results of skin testing had no adverse reaction. However, anaphylaxis developed in the other 2 patients administered the culprit ICM again. With 64.7% (11/17) and 50% (3/6) of the sensitivities of corresponding allergic skin tests with culprit ICM for immediate and delayed hypersensitivity reactions, the present study suggests that skin tests is useful for the diagnosis of ICM hypersensitivity and for selecting safe ICM and preventing a recurrence of anaphylaxis caused by the same ICM.

  17. Skin Color and Pigmentation in Ethnic Skin.

    PubMed

    Visscher, Marty O

    2017-02-01

    Skin coloration is highly diverse, partly due to the presence of pigmentation. Color variation is related to the extent of ultraviolet radiation exposure, as well as other factors. Inherent skin coloration arises from differences in basal epidermal melanin amount and type. Skin color is influenced by both the quantity and distribution of melanocytes. The effectiveness of inherent pigmentation for protecting living cells also varies. This article discusses skin color, pigmentation, and ethnicity in relation to clinical practice. Color perception, skin typing/classification, and quantitation of pigmentation are reviewed in relation to ethnicity, environmental stresses/irritants, and potential treatment effects. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Natural rubber latex skin testing reagents: safety and diagnostic accuracy of nonammoniated latex, ammoniated latex, and latex rubber glove extracts.

    PubMed

    Hamilton, R G; Adkinson, N F

    1996-11-01

    Nonammoniated latex, ammoniated latex, and rubber glove extracts are the only sources of natural rubber (Hevea brasiliensis) latex that have potential for use as skin testing reagents in the diagnosis of latex allergy. Their diagnostic sensitivity and specificity as skin test reagents are unknown. We conducted a phase 1/2 clinical study to examine the safety and diagnostic accuracy (sensitivity and specificity) of nonammoniated latex, ammoniated latex, and rubber glove extracts as skin test extracts to identify the most efficacious source material for future skin test reagent development. Twenty-four adults not allergic to latex, 19 adults with hand dermatitis or pruritus, and 59 adults with a latex allergy were identified by clinical history. All provided blood and then received puncture skin tests and intradermal skin tests with nonammoniated latex, ammoniated latex, and rubber glove extracts from Malaysian H. brasiliensis latex by use of sequential titration. A glove provocation test and IgE anti-latex RAST were used to clarify positive history-negative skin test response and negative history-positive skin test response mismatches. All three extracts were biologically safe and sterile. After normalization to 1 mg/ml of total protein, all three extracts produced equivalent diagnostic sensitivity and specificity in puncture skin tests and intradermal skin tests at various extract concentrations. Optimal diagnostic accuracy was safely achieved at 100 micrograms/ml for intradermal skin tests (e.g., nonammoniated latex: puncture skin test sensitivity 96%, specificity 100%; intradermal skin test sensitivity 93%, specificity 96%). The presence of IgE antibody in skin was highly correlated with IgE anti-latex in serum (nonammoniated latex: r = 0.98, p < 0.001; ammoniated latex: r = 0.94, p < 0.001; rubber glove extract: r = 0.96, p < 0.001). All five available subjects with a positive history, negative skin test response, and absence of IgE antibody in serum had a

  19. Usefulness and limitations of various guinea-pig test methods in detecting human skin sensitizers-validation of guinea-pig tests for skin hypersensitivity.

    PubMed

    Marzulli, F; Maguire, H C

    1982-02-01

    Several guinea-pig predictive test methods were evaluated by comparison of results with those obtained with human predictive tests, using ten compounds that have been used in cosmetics. The method involves the statistical analysis of the frequency with which guinea-pig tests agree with the findings of tests in humans. In addition, the frequencies of false positive and false negative predictive findings are considered and statistically analysed. The results clearly demonstrate the superiority of adjuvant tests (complete Freund's adjuvant) in determining skin sensitizers and the overall superiority of the guinea-pig maximization test in providing results similar to those obtained by human testing. A procedure is suggested for utilizing adjuvant and non-adjuvant test methods for characterizing compounds as of weak, moderate or strong sensitizing potential.

  20. QSAR models of human data can enrich or replace LLNA testing for human skin sensitization

    PubMed Central

    Alves, Vinicius M.; Capuzzi, Stephen J.; Muratov, Eugene; Braga, Rodolpho C.; Thornton, Thomas; Fourches, Denis; Strickland, Judy; Kleinstreuer, Nicole; Andrade, Carolina H.; Tropsha, Alexander

    2016-01-01

    Skin sensitization is a major environmental and occupational health hazard. Although many chemicals have been evaluated in humans, there have been no efforts to model these data to date. We have compiled, curated, analyzed, and compared the available human and LLNA data. Using these data, we have developed reliable computational models and applied them for virtual screening of chemical libraries to identify putative skin sensitizers. The overall concordance between murine LLNA and human skin sensitization responses for a set of 135 unique chemicals was low (R = 28-43%), although several chemical classes had high concordance. We have succeeded to develop predictive QSAR models of all available human data with the external correct classification rate of 71%. A consensus model integrating concordant QSAR predictions and LLNA results afforded a higher CCR of 82% but at the expense of the reduced external dataset coverage (52%). We used the developed QSAR models for virtual screening of CosIng database and identified 1061 putative skin sensitizers; for seventeen of these compounds, we found published evidence of their skin sensitization effects. Models reported herein provide more accurate alternative to LLNA testing for human skin sensitization assessment across diverse chemical data. In addition, they can also be used to guide the structural optimization of toxic compounds to reduce their skin sensitization potential. PMID:28630595

  1. The use of a measure of acute irritation to predict the outcome of repeated usage of hand soap products.

    PubMed

    Williams, C; Wilkinson, M; McShane, P; Pennington, D; Fernandez, C; Pierce, S

    2011-06-01

    Healthcare-associated infection is an important worldwide problem that could be reduced by better hand hygiene practice. However, an increasing number of healthcare workers are experiencing irritant contact dermatitis of the hands as a result of repeated hand washing. This may lead to a reduced level of compliance with regard to hand hygiene. To assess whether a measure of acute irritation by hand soaps could predict the effects of repeated usage over a 2-week period. In a double-blind, randomized comparison study, the comparative irritation potential of four different hand soaps was assessed over a 24-h treatment period. The effect of repeated hand washing with the hand soap products over a 2-week period in healthy adult volunteers on skin barrier function was then determined by assessment of transepidermal water loss (TEWL), epidermal hydration and a visual assessment using the Hand Eczema Severity Index (HECSI) at days 0, 7 and 14. A total of 121 subjects from the 123 recruited completed phase 1 of the study. All four products were seen to be significantly different from each other in terms of the irritant reaction observed and all products resulted in a significantly higher irritation compared with the no-treatment control. Seventy-nine of the initial 121 subjects were then enrolled into the repeated usage study. A statistically significant worsening of the clinical condition of the skin as measured by HECSI was seen from baseline to day 14 in those subjects repeatedly washing their hands with two of the four soap products (products C and D) with P-values of 0·02 and 0·01, respectively. Subclinical assessment of the skin barrier function by measuring epidermal hydration was significantly increased from baseline to day 7 after repeated hand washing with products A, B and D but overall no significant change was seen in all four products tested by day 14. A statistically significant increase in TEWL at day 14 was seen for product A (P = 0·02) indicating a

  2. Use of genotoxicity information in the development of integrated testing strategies (ITS) for skin sensitization.

    PubMed

    Mekenyan, Ovanes; Patlewicz, Grace; Dimitrova, Gergana; Kuseva, Chanita; Todorov, Milen; Stoeva, Stoyanka; Kotov, Stefan; Donner, E Maria

    2010-10-18

    Skin sensitization is an end point of concern for various legislation in the EU, including the seventh Amendment to the Cosmetics Directive and Registration Evaluation, Authorisation and Restriction of Chemicals (REACH). Since animal testing is a last resort for REACH or banned (from 2013 onward) for the Cosmetics Directive, the use of intelligent/integrated testing strategies (ITS) as an efficient means of gathering necessary information from alternative sources (e.g., in vitro, (Q)SARs, etc.) is gaining widespread interest. Previous studies have explored correlations between mutagenicity data and skin sensitization data as a means of exploiting information from surrogate end points. The work here compares the underlying chemical mechanisms for mutagenicity and skin sensitization in an effort to evaluate the role mutagenicity information can play as a predictor of skin sensitization potential. The Tissue Metabolism Simulator (TIMES) hybrid expert system was used to compare chemical mechanisms of both end points since it houses a comprehensive set of established structure-activity relationships for both skin sensitization and mutagenicity. The evaluation demonstrated that there is a great deal of overlap between skin sensitization and mutagenicity structural alerts and their underlying chemical mechanisms. The similarities and differences in chemical mechanisms are discussed in light of available experimental data. A number of new alerts for mutagenicity were also postulated for inclusion into TIMES. The results presented show that mutagenicity information can provide useful insights on skin sensitization potential as part of an ITS and should be considered prior to any in vivo skin sensitization testing being initiated.

  3. A SKIN TEST FOR DETECTING GROUP C HEMOLYTIC STREPTOCOCCAL INFECTION CAUSING EPIZOOTIC LYMPHADENITIS IN GUINEA PIGS

    PubMed Central

    Moen, Johannes K.

    1936-01-01

    1. A skin test with a crude bacterial extract prepared from group C (Lancefield) hemolytic streptococci was used as a means of detecting possible carriers of the streptococcus causing epizootic lymphadenitis in guinea pigs. A positive test similar to a positive tuberculin reaction was considered presumptive evidence of present or recent infection with this streptococcus. 2. 20 positive reactors were found in 330 supposedly normal guinea pigs. 3. 195 negatively reacting animals were used as a breeding stock which yielded 1,296 progeny over a period of 15 months. None of the breeding stock or their progeny showed evidence of spontaneous lymphadenitis. Skin tests of 100 of the progeny were all negative. 4. The use of this skin test as a means of obtaining guinea pig breeding stock free of the streptococcus causing spontaneous lymphadenitis is suggested. PMID:19870552

  4. The developmental psychopathology of irritability

    PubMed Central

    LEIBENLUFT, ELLEN; STODDARD, JOEL

    2015-01-01

    Chronic, severe irritability is common in childhood and is very impairing. Furthermore, childhood irritability predicts suicidality, social impairment, and depressive and anxiety disorders in adulthood. Focusing on both normative and pathologic development, we review the construct of irritability from its origins in aggression and disruptive behavior research to its contemporary relevance for affective psychopathology. We then describe two broad neurocognitive systems that show promise in differentiating irritable from nonirritable youths: aberrant processing of emotional stimuli and impaired context-sensitive regulation. We suggest behavioral, neurocognitive, and physiologic measures that may aid in studying severe irritability and assessing its therapeutics. Finally, we argue for therapeutic trials targeting severe irritability that address emotional aspects of irritability in addition to the associated disruptive behavior. PMID:24342851

  5. 78 FR 68076 - Request for Information on Alternative Skin Sensitization Test Methods and Testing Strategies and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ... INFORMATION: Background: Allergic contact dermatitis (ACD), a skin reaction characterized by localized redness, swelling, blistering, or itching after direct contact with a skin allergen, is an important public health.... Web site: http://ntp.niehs.nih.gov/go/niceatm . FOR FURTHER INFORMATION CONTACT: Dr. Warren S. Casey...

  6. Irritant-induced asthma.

    PubMed

    Labrecque, Manon

    2012-04-01

    To describe the recent insights into the definition, causes, natural outcome, and key elements of irritant-induced asthma (IIA) management. IIA is a subtype of occupational asthma without immunologic sensitization and includes the typical reactive airway dysfunction syndrome (RADS) and a more gradual form called not-so-sudden IIA, when onset of asthma follows repeated low-dose exposure to irritants. The World Trade Center tragedy brought new insight in the understanding of IIA, suggesting that it can exhibit a prolonged interval between exposure and recognition of clinical symptoms and disease. Dimethyl sulfate has been recently reported to cause RADS and repeated diesel exhaust exposure to cause not-so-sudden IIA in patients who worked in a bus garage. Cleaning workers who are exposed to a large variety of irritants and sensitizers are especially at risk of occupational asthma and IIA. IIA includes RADS and not-so-sudden IIA. Outcome of IIA is as poor as occupational asthma with sensitization. Treatment of IIA does not differ from standard asthma treatment, but high-dose vitamin D could be assessed further for possible therapeutic benefit.

  7. Utility testing of an apple skin color MdMYB1 marker in two progenies

    USDA-ARS?s Scientific Manuscript database

    A reported allele-specific dCAP PCR marker associated with apple fruit red skin color was tested in 18 elite breeding parents and two apple cross populations. Among all tested cultivars except one, a consistent relationship was observed between red fruit color and the presence of allele. In both pop...

  8. Self-perceived sensory responses to soap and synthetic detergent bars correlate with clinical signs of irritation.

    PubMed

    Simion, F A; Rhein, L D; Morrison, B M; Scala, D D; Salko, D M; Kligman, A M; Grove, G L

    1995-02-01

    Epidemiologic studies indicate that after using soaps and other personal care products, many consumers experience irritation. In 50% of the cases the feelings of skin dryness, itching, and stinging occur in the absence of visible signs of irritation. We sought to determine the relation between self-perceived sensory responses of panelists to cleansing products and clinical signs of irritation. A combination of exaggerated arm-washing methods was designed to induce clinical signs of irritation with psychometric techniques developed to quantify sensations. Two studies demonstrated that panelists could reproducibly differentiate between products on the basis of the sensations they felt and that there was a significant correlation (frequently r > 0.80) between these and the observable signs. In the case of skin dryness panelists differentiated products several washing cycles before observable differences were detected. Sensory evaluations of irritation yield additional information on soap and detergent irritancy beyond clinical observations and expand understanding of the irritation process.

  9. Non-immediate reactions to beta-lactams: diagnostic value of skin testing and drug provocation test.

    PubMed

    Padial, A; Antunez, C; Blanca-Lopez, N; Fernandez, T D; Cornejo-Garcia, J A; Mayorga, C; Torres, M J; Blanca, M

    2008-05-01

    beta-Lactam (BL) antibiotics can induce non-immediate skin reactions, frequently manifested as exanthema or urticaria. The time between drug intake and the reaction appearance is generally 24-48 h. Because the mechanisms involved are not completely understood, diagnostic tests for these reactions have still to be fully validated. To evaluate the role of skin and drug provocation tests (DPTs) in the diagnosis of patients with non-immediate reactions to BL. We evaluated a group of 22 patients who developed maculopapular exanthema or urticarial exanthema after BL intake. Diagnosis was confirmed by DPT with BL. Intradermal/patch testing was performed with benzylpenicilloyl, minor determinant mixture, amoxicillin (AX), ampicillin (AMP) and the culprit drug in patients and in 22 negative controls. Immunohistochemical studies were done in the affected skin at the acute phase of the reaction and after a delayed positive skin test/DPT. IFN-gamma and IL-4 were quantified in peripheral mononuclear cells, obtained during the positive response to DPT and after resolution of the symptoms. From the total number of cases, 12 patients developed urticarial exanthema and 10 maculopapular exanthema after DPT. Only two of the 22 patients (9%) had a positive delayed intradermal skin test: one to AX/AMP and the other to cloxacillin. Biopsies showed a mononuclear CD4, CD8 infiltrate and activated and memory cells. The cytokine expression showed a Th1 pattern in patients, in contrast with the Th0 pattern in controls. In patients with non-immediate reactions to BLs (maculopapular exathema or urticarial exanthema), the sensitivity of skin testing is low and DPT may be required to establish the diagnosis. The reproducibility of the reactions and the cytokine pattern expressed during the acute episode support a T cell-induced non-immediate response.

  10. Differential skin test reactivity to pollens in pollen food allergy syndrome versus allergic rhinitis.

    PubMed

    Ta, Von; Scott, David R; Chin, William K; Wineinger, Nathan E; Kelso, John M; White, Andrew A

    2015-01-01

    Pollen food allergy syndrome (PFAS), also called oral allergy syndrome, is a form of food allergy in which uncooked foods cause allergic symptoms generally limited to the oral mucosa. It occurs in a subset of patients with pollen allergy, although not all patients have prominent rhinitis symptoms. PFAS is related to antigenic similarity between the pollen and food allergen. The size of skin test reactions in a group of subjects with pollen sensitivity with PFAS was compared with a group of subjects who were pollen sensitive and without PFAS. Self-reported rhinitis symptoms between the two groups were compared to identify if symptom severity differed. Twenty subjects with PFAS and 20 subjects with seasonal allergic rhinitis without PFAS were enrolled in the study. All the subjects underwent standard skin-prick testing to a panel of common allergens, including select fresh fruits and vegetables. The subjects completed a Mini Rhinoconjunctivitis Quality of Life Questionnaire as part of their clinical evaluation. The subjects with PFAS and those without PFAS were compared statistically. The subjects with PFAS had significantly larger-sized skin-prick test results specific to pollens (p < 0.05). Despite the larger-sized skin-prick test results, the subjects with allergic rhinitis and PFAS reported milder nasal symptoms in relation to pollen skin test result size when compared with allergic rhinitis controls without PFAS. Our study outlined basic differences between two seemingly similar patient groups with a particularly striking discordance between skin test result sizes and rhinitis symptoms. This discordance should be explored further to increase mechanistic understanding of allergen cross-reactivity in PFAS.

  11. Diagnosis of mold allergy by RAST and skin prick testing.

    PubMed

    Nordvall, S L; Agrell, B; Malling, H J; Dreborg, S

    1990-11-01

    Sera from 33 patients with mold allergy proven by bronchial provocation were analyzed for specific IgE against six mold species comparing an improved Phadebas RAST with four other techniques. The new method was more sensitive and gave significantly higher IgE antibody concentrations for all tested molds except Cladosporium herbarum.

  12. Tannins from Potentilla officinalis display antiinflammatory effects in the UV erythema test and on atopic skin.

    PubMed

    Hoffmann, Julia; Wölfle, Ute; Schempp, Christoph M; Casetti, Federica

    2016-09-01

    Rich in tannins, the rhizome of Potentilla officinalis (PO) has traditionally been used in the topical treatment of inflammatory disorders of the skin and mucous membranes. The objective of the present study was to examine the antiinflammatory effects of PO in the UV erythema test as well as in patients with atopic skin. Using the UV erythema test, the antiinflammatory effects of a PO extract (2 %) - compared to 1 % hydrocortisone acetate - were assessed in a randomized, prospective, placebo-controlled double-blind study of 40 healthy volunteers. In the context of a prospective non-controlled trial, the efficacy and tolerability of 2 % PO cream (applied to defined test areas twice daily for two weeks) was evaluated in twelve adults and twelve children with atopic skin using a partial SCORAD. In addition, the effects on the degree of erythema in the test areas was measured photometrically. In the UV erythema test, PO cream significantly reduced the erythema index compared to the vehicle. The antiinflammatory effects of PO cream were comparable to those of 1 % hydrocortisone acetate cream. The clinical study with atopic patients revealed a significant reduction in the partial SCORAD as well as erythema in the test areas. No adverse events were recorded. PO cream displays antiinflammatory effects in vivo. It is effective in and well tolerated by patients with atopic skin. © 2016 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

  13. Biopharmaceutical Assessment and Irritation Potential of Microemulsions and Conventional Systems Containing Oil from Syagrus cearensis for Topical Delivery of Amphotericin B Using Alternative Methods.

    PubMed

    Sousa, Giovana D; Kishishita, Juliana; Aquino, Kátia A S; Presgrave, Octávio A F; Leal, Leila B; Santana, Davi P

    2017-07-01

    The aim of this study was to compare the biopharmaceutical characteristics and irritation potentials of microemulsions (MEs) and conventional systems (CSs) containing oil from Syagrus cearensis for topical delivery of Amphotericin B (AmB). Pseudo-ternary phase diagrams were constructed using a water titration method to develop the MEs, and the CSs were prepared according to the classical technique of phase inversion. In the skin permeation and retention study, dermatomed pig skin without stratum corneum was used as an alternative disturbed skin model. The irritation potential was evaluated using three different methods, chorioallantoic membrane assays (HET-CAM and CAM-TBS), and bovine corneal opacity and permeability (BCOP) test. The optimized formulation (ME1) consisting of 0.1% (w/w) Amphotericin B, 9.1% (w/w) catolé oil, 81% (w/w) Smix (1:1, Tween 20 and Kolliphor EL) possessed droplet size of 31.02 ± 0.9 nm, zeta potential of -23.4 mV, and viscosity 0.63 ± 0.1 Pa.s. ME1 exhibited greater retention of AmB in to skin layers (84.79 ± 2.08 μg cm -2 ) than all the others formulations. In general, MEs showed higher drug release and retention than CSs and all of the formulations showed greater retentivity than permeability. Only MEs developed using Labrasol/Plurol Oleique (L/PO) as the surfactant and co-surfactant exhibited a moderate irritation potential; all other MEs and CSs were classified as non-irritants or slight irritants. The results indicate that formulations containing oil from S. cearensis are promising alternatives for the delivery of AmB targeting the treatment of cutaneous leishmaniasis.

  14. Dermal safety assessment of Arm & Hammer laundry products formulated for sensitive skin.

    PubMed

    Frederick, Douglas M; Vorwerk, Linda; Gupta, Archana; Ghassemi, Annahita

    2017-09-01

    The prevalence of sensitive skin among the general population in industrialized countries is reported to be over 50%. Sensitive skin subjects often report significant reactions to contact with cosmetics, soaps and other consumer products. This paper describes the overall skin compatibility and mildness program for a newly developed, lightly fragranced, colorant free laundry product (i.e. Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent), specially formulated for individuals with sensitive skin. The skin mildness of the product was compared to Arm & Hammer™ Free & Clear liquid laundry detergent with no fragrance or colorant, and an established history of safe use by sensitive skin consumers. The test material was a liquid laundry product with a light scent formulated for sensitive skin consumers (Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent). The product was compared to commercially marketed products for sensitive skin with a history of skin safety in the marketplace, including: a very similar product formulation (Arm & Hammer™ Free & Clear with no fragrance), and several selected competitors' products. Studies were conducted among individuals with self-assessed sensitive skin (based on a questionnaire) using standard protocols for the Human Repeat Insult Patch Test (HRIPT), 10-Day Cumulative Irritation, the Wrist Band Wear test, and the Safety In-Use testing. Responses in all protocols were evaluated by visual scoring of potential dermatologic reactions, and recording any sensory effects at the time of the examination. In addition, sensory effects collected from panelists' daily diaries were also evaluated. The HRIPT confirmed that neither the fragrance alone, nor the product formulation with fragrance, induced contact sensitization in sensitive skin subjects. The 10-Day cumulative irritation study conducted using sensitive skin subjects showed highly favorable skin compatibility, and the test product was comparable to the control

  15. Positive Skin Test or Specific IgE to Penicillin Does Not Reliably Predict Penicillin Allergy.

    PubMed

    Tannert, Line Kring; Mortz, Charlotte Gotthard; Skov, Per Stahl; Bindslev-Jensen, Carsten

    According to guidelines, patients are diagnosed with penicillin allergy if skin test (ST) result or specific IgE (s-IgE) to penicillin is positive. However, the true sensitivity and specificity of these tests are presently not known. To investigate the clinical relevance of a positive ST result and positive s-IgE and to study the reproducibility of ST and s-IgE. A sample of convenience of 25 patients with positive penicillin ST results, antipenicillin s-IgE results, or both was challenged with their culprit penicillin. Further 19 patients were not challenged, but deemed allergic on the basis of a recent anaphylactic reaction or delayed reactions to skin testing. Another sample of convenience of 18 patients, 17 overlapping with the 25 challenged, with initial skin testing and s-IgE (median, 25; range, 3-121), months earlier (T -1 ), was repeat skin tested and had s-IgE measured (T 0 ), and then skin tested and had s-IgE measured 4 weeks later (T 1 ). Only 9 (36%) of 25 were challenge positive. There was an increased probability of being penicillin allergic if both ST result and s-IgE were positive at T 0 . Positive ST result or positive s-IgE alone did not predict penicillin allergy. Among the 18 patients repeatedly tested, 46.2% (12 of 25) of positive ST results at T -1 were reproducibly positive at T 0 . For s-IgE, 54.2% (14 of 24) positive measurements were still positive at T 0 and 7 converted to positive at T 1 . The best predictor for a clinically significant (IgE-mediated) penicillin allergy is a combination of a positive case history with simultaneous positive ST result and s-IgE or a positive challenge result. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  16. Estimation of the viscous properties of skin and subcutaneous tissue in uniaxial stress relaxation tests.

    PubMed

    Wu, John Z; Cutlip, Robert G; Welcome, Daniel; Dong, Ren G

    2006-01-01

    Knowledge of viscoelastic properties of soft tissues is essential for the finite element modelling of the stress/strain distributions in finger-pad during vibratory loading, which is important in exploring the mechanism of hand-arm vibration syndrome. In conventional procedures, skin and subcutaneous tissue have to be separated for testing the viscoelastic properties. In this study, a novel method has been proposed to simultaneously determine the viscoelastic properties of skin and subcutaneous tissue in uniaxial stress relaxation tests. A mathematical approach has been derived to obtain the creep and relaxation characteristics of skin and subcutaneous tissue using uniaxial stress relaxation data of skin/subcutaneous composite specimens. The micro-structures of collagen fiber networks in the soft tissue, which underline the tissue mechanical characteristics, will be intact in the proposed method. Therefore, the viscoelastic properties of soft tissues obtained using the proposed method would be more physiologically relevant than those obtained using the conventional method. The proposed approach has been utilized to measure the viscoelastic properties of soft tissues of pig. The relaxation curves of pig skin and subcutaneous tissue obtained in the current study agree well with those in literature. Using the proposed approach, reliable material properties of soft tissues can be obtained in a cost- and time-efficient manner, which simultaneously improves the physiological relevance.

  17. Irritable bowel syndrome.

    PubMed

    Malone, Michael A

    2011-09-01

    Irritable bowel syndrome (IBS) is a common gastrointestinal disorder that leads to crampy pain, gassiness, bloating, and changes in bowel habits in the absence of any currently identifiable organic disorder. Patients with IBS may be classified by their predominant bowel habit: diarrhea-predominant, constipation-predominant, or IBS with alternating bowel movements. IBS is often associated with stress or anxiety. Although IBS can be frustrating and concerning to patients with this disorder, it does not cause permanent harm to the intestines and does not lead to a serious disease such as cancer. Although treatments exist for its symptoms, there is no known cure. Copyright © 2011 Elsevier Inc. All rights reserved.

  18. Irritant contact dermatitis from an ornamental Euphorbia.

    PubMed

    Worobec, S M; Hickey, T A; Kinghorn, A D; Soejarto, D D; West, D

    1981-01-01

    An ornamental succulent plant sold in many plant stores in the Chicago area has been identified as Euphorbia hermentiana Lem. Open and closed patch testing using undiluted latex from this species was performed on five Caucasian volunteers. Open testing on flexor forearms resulted in irritant follicular dermatitis, while closed testing to the flexor surfaces of both upper arms in each subject produced bullae and vesiculation with residual desquamation and hyperpigmentation. Dermatological signs persisted for over a week following latex application.

  19. Role of alimentation in irritable bowel syndrome.

    PubMed

    Dapoigny, M; Stockbrügger, R W; Azpiroz, F; Collins, S; Coremans, G; Müller-Lissner, S; Oberndorff, A; Pace, F; Smout, A; Vatn, M; Whorwell, P

    2003-01-01

    Different food items are made responsible for irritable bowel syndrome (IBS) symptoms, but the physiopathology of IBS remains unclear. During a meeting in Nice, France, experts of the European Working Team of the IBiS Club discussed selected data regarding the relationships between alimentation, food items (including fibers) and IBS symptoms. Food allergy remains a difficult diagnosis, but medical and general history, presence of general symptoms such as skin rash, and hypersensitivity tests may help in achieving a positive diagnosis. On the other hand, food intolerance is more confusing because of the subjectivity of the relationship between ingestion of certain foods and the appearance of clinical symptoms. Different food items which are commonly implicated in adverse reactions mimicking IBS were found to be stimulants for the gut, suggesting that patients with predominant diarrhea IBS have to be carefully questioned about consumption of different kinds of food (i.e., coffee, alcohol, chewing gum, soft drinks) and not only on lactose ingestion. Gas production is discussed on the basis of retention of intestinal gas as well as on malabsorption of fermentable substrates. The role of a large amount of this kind of substrate reaching the colon is suggested as a potential mechanism of IBS-type symptoms in overeating patients. Regarding the role of fiber in IBS, the expert group concluded that fibers are not inert substances and that they could trigger pain or bloating in some IBS patients. Despite numerous reviews on this subject, it is very difficult to give general dietary advice to IBS patients, but dieteticians may have a positive role in managing such patients. Copyright 2003 S. Karger AG, Basel

  20. Anaphylaxis to Spirulina confirmed by skin prick test with ingredients of Spirulina tablets.

    PubMed

    Le, Thuy-My; Knulst, André C; Röckmann, Heike

    2014-12-01

    Spirulina (Arthrospira platensis), blue-green microalgae, has high content in proteins, γ-linoleic acid and vitamins and therefore gained popularity as food supplement. According to the Food and Agriculture Organization of the United Nations Spirulina is also an interesting alternative and sustainable protein source with the growing world population. We present a case of a 17-year-old male, who developed anaphylaxis the first time he ingested a Spirulina tablet. Skin prick test with diluted Spirulina tablet was positive. Further skin prick testing with separated ingredients (Spirulina platensis algae, silicon dioxide, inulin and magnesium stearate) was only positive for Spirulina platensis algae and negative in controls, confirming the allergy was caused by Spirulina and not by one of the additives. This case report shows that diagnosis of Spirulina allergy can safely be made by skin prick test with dilutions of the A. platensis or even more simple by skin prick test with the diluted tablet. Since Spirulina has gained popularity as food and nutritional supplement, it is important to realize the potential risk of this dietary supplement. Before Spirulina is produced and consumed on a wider scale, allergenicity risk assessment should be performed, including investigation of potential crossreactivity with well-known inhalant allergens and foods.

  1. Menthol attenuates respiratory irritation responses to multiple cigarette smoke irritants

    PubMed Central

    Willis, Daniel N.; Liu, Boyi; Ha, Michael A.; Jordt, Sven-Eric; Morris, John B.

    2011-01-01

    Menthol, the cooling agent in peppermint, is added to almost all commercially available cigarettes. Menthol stimulates olfactory sensations, and interacts with transient receptor potential melastatin 8 (TRPM8) ion channels in cold-sensitive sensory neurons, and transient receptor potential ankyrin 1 (TRPA1), an irritant-sensing channel. It is highly controversial whether menthol in cigarette smoke exerts pharmacological actions affecting smoking behavior. Using plethysmography, we investigated the effects of menthol on the respiratory sensory irritation response in mice elicited by smoke irritants (acrolein, acetic acid, and cyclohexanone). Menthol, at a concentration (16 ppm) lower than in smoke of mentholated cigarettes, immediately abolished the irritation response to acrolein, an agonist of TRPA1, as did eucalyptol (460 ppm), another TRPM8 agonist. Menthol's effects were reversed by a TRPM8 antagonist, AMTB. Menthol's effects were not specific to acrolein, as menthol also attenuated irritation responses to acetic acid, and cyclohexanone, an agonist of the capsaicin receptor, TRPV1. Menthol was efficiently absorbed in the respiratory tract, reaching local concentrations sufficient for activation of sensory TRP channels. These experiments demonstrate that menthol and eucalyptol, through activation of TRPM8, act as potent counterirritants against a broad spectrum of smoke constituents. Through suppression of respiratory irritation, menthol may facilitate smoke inhalation and promote nicotine addiction and smoking-related morbidities.— Willis, D. N., Liu, B., Ha, M. A., Jordt, S.-E., Morris, J. B. Menthol attenuates respiratory irritation responses to multiple cigarette smoke irritants. PMID:21903934

  2. Relationships between skin test, specific IgE and levels of cytokines in patients with penicillin allergy.

    PubMed

    Qiao, H-L; Liu, J-H; Yang, J; Dong, Z-M

    2005-08-01

    The aim of this study was to investigate the relationships between skin test, specific immunoglobulin (Ig) E and cytokines in penicillin allergy. We collected the sera of 259 patients with historical positive skin test to penicillins, with immediate positive skin test and with a negative skin test results. The positive rate of specific IgE antibodies in 259 patients was 62.2% (161) by using radioallergosorbent test (RAST). Of the eight kinds of antigenic determinants, the positive rates of specific IgE to major and minor determinants were 43.63% (113) and 52.51% (136), respectively (p < 0.05). In 122 patients with immediate positive skin test, when the degrees of skin test were +, 2+, 3+ and 4+, the positive rates of specific IgE were 45.7, 57.1, 85.2 and 100%, respectively. The levels of interleukin (IL)-4, IL-13 and interferon (IFN)-gamma in the sera of patients with positive skin test were significantly increased with the degree of positive skin test (p < 0.05). The combined use of major and minor determinants in RAST offers the better test for the detection of penicillin-specific IgE antibodies. IL-4, IL-13 and IFN-gamma play important roles in penicillin allergy.

  3. Hypersensitivity reactions to penicillins: studies in a group of patients with negative benzylpenicillin G skin test.

    PubMed

    Qiao, H-L; Li, Z; Yang, J; Tian, X; Gao, N; Jia, L-J

    2009-06-01

    Although skin tests are usually employed to evaluate current penicillin allergy status, a negative result does not exclude hypersensitivity. There is a need for accurate in vitro tests to exclude hypersensitivity. A radioallergosorbent test (RAST) is a potentially good supplementary approach, but there is little information on the suitability of this method to diagnose penicillin hypersensitivity in subjects with a negative skin test to benzylpenicillin. A total of 133 patients with a negative skin test to benzylpenicillin G (PG) and all of whom developed allergic reactions to PG were studied. RAST was used to detect eight kinds of specific IgE antibodies to penicillins in serum, which included four kinds of major and minor antigenic determinants to four penicillin drugs. The combination sites for the specific IgE antibodies were studied by RAST inhibition test. The rate of positive reactions for the specific IgE antibodies was 59.40% (79/133). Of the eight kinds of antigenic determinants, the positive rates for specific IgE against the major and minor determinants were 39.10% (52) and 42.86% (57) respectively. Of the four drugs, positive cases only to PG were 10 (7.5%), were significantly fewer than the cross-reacting positive cases (36) to PG (P < 0.01). In the RAST inhibition studies all drugs exhibited good inhibitory potencies, and in some instances the side-chain of the penicillins could induce specific responses with a variable degree of cross-reactivity among the different penicillins. Radioallergosorbent test is a good complementary test in persons who are skin-test negative with PG, and the sensitivity of RAST increases with increasing specificity of IgE antibodies to be detected. 6-APA and the groups, making part of the different side-chains on penicillins, all contributed to the cross-reactivity.

  4. The adverse outcome pathway for skin sensitisation: Moving closer to replacing animal testing.

    PubMed

    Schultz, Terry W; Dimitrova, Gergana; Dimitrov, Sabcho; Mekenyan, Ovanes G

    2016-10-01

    This article outlines the work of the Organisation for Economic Co-operation and Development (OECD) that led to being jointly awarded the 2015 Lush Black Box Prize. The award-winning work centred on the development of 'The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent Binding to Proteins'. This Adverse Outcome Pathway (AOP) has provided the mechanistic basis for the integration of skin sensitisation-related information. Recent developments in integrated approaches to testing and assessment, based on the AOP, are summarised. The impact of the AOP on regulatory policy and on the Three Rs are discussed. An overview of the next generation of the skin sensitisation AOP module in the OECD QSAR Toolbox, based on more-recent work at the Laboratory of Mathematical Chemistry, is also presented. 2016 FRAME.

  5. How Stress and Anxiety Can Alter Immediate and Late Phase Skin Test Responses in Allergic Rhinitis

    PubMed Central

    Kiecolt-Glaser, Janice K.; Heffner, Kathi L.; Glaser, Ronald; Malarkey, William B.; Porter, Kyle; Atkinson, Cathie; Laskowski, Bryon; Lemeshow, Stanley; Marshall, Gailen D.

    2010-01-01

    Summary Allergic rhinitis (AR) is the fifth most common chronic disease, and the association between allergic disorders and anxiety is well-documented. To investigate how anxiety and stressors modulate skin prick test (SPT) responses and associated inflammatory responses, 28 men and women with AR were selected by clinical history and skin test responses. The participants were admitted twice to a hospital research unit for 4 hours in a crossover trial. Changes in SPT wheals were assessed before and after a standardized laboratory speech stressor, as well as again the following morning; skin responses assessed twice during a lab session without a stressor and again the following morning served as the contrast condition. Anxiety heightened the magnitude of allergen-induced wheals following the stressor. As anxiety increased, SPT wheal diameters increased after the stressor, compared to a slight decrease following the control task. Anxiety also substantially enhanced the effects of stress on late phase responses: even skin tests performed the day after the stressor reflected the continuing impact of the speech stressor among the more anxious participants. Greater anxiety was associated with more IL-6 production by Con A-stimulated leukocytes following the stressor compared to the control visit. The data suggest that stress and anxiety can enhance and prolong AR symptoms. PMID:19150180

  6. The development and testing of a skin tear risk assessment tool.

    PubMed

    Newall, Nelly; Lewin, Gill F; Bulsara, Max K; Carville, Keryln J; Leslie, Gavin D; Roberts, Pam A

    2017-02-01

    The aim of the present study is to develop a reliable and valid skin tear risk assessment tool. The six characteristics identified in a previous case control study as constituting the best risk model for skin tear development were used to construct a risk assessment tool. The ability of the tool to predict skin tear development was then tested in a prospective study. Between August 2012 and September 2013, 1466 tertiary hospital patients were assessed at admission and followed up for 10 days to see if they developed a skin tear. The predictive validity of the tool was assessed using receiver operating characteristic (ROC) analysis. When the tool was found not to have performed as well as hoped, secondary analyses were performed to determine whether a potentially better performing risk model could be identified. The tool was found to have high sensitivity but low specificity and therefore have inadequate predictive validity. Secondary analysis of the combined data from this and the previous case control study identified an alternative better performing risk model. The tool developed and tested in this study was found to have inadequate predictive validity. The predictive validity of an alternative, more parsimonious model now needs to be tested. © 2015 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

  7. Biodegradable Polymers Induce CD54 on THP-1 Cells in Skin Sensitization Test.

    PubMed

    Jung, Yeon Suk; Kato, Reiko; Tsuchiya, Toshie

    2011-01-01

    Currently, nonanimal methods of skin sensitization testing for various chemicals, biodegradable polymers, and biomaterials are being developed in the hope of eliminating the use of animals. The human cell line activation test (h-CLAT) is a skin sensitization assessment that mimics the functions of dendritic cells (DCs). DCs are specialized antigen-presenting cells, and they interact with T cells and B cells to initiate immune responses. Phenotypic changes in DCs, such as the production of CD86 and CD54 and internalization of MHC class II molecules, have become focal points of the skin sensitization test. In this study, we used h-CLAT to assess the effects of biodegradable polymers. The results showed that several biodegradable polymers increased the expression of CD54, and the relative skin sensitizing abilities of biodegradable polymers were PLLG (75 : 25) < PLLC (40 : 60) < PLGA (50 : 50) < PCG (50 : 50). These results may contribute to the creation of new guidelines for the use of biodegradable polymers in scaffolds or allergenic hazards.

  8. Surprisingly high specificity of the PPD skin test for M. tuberculosis infection from recent exposure in The Gambia.

    PubMed

    Hill, Philip C; Brookes, Roger H; Fox, Annette; Jackson-Sillah, Dolly; Lugos, Moses D; Jeffries, David J; Donkor, Simon A; Adegbola, Richard A; McAdam, Keith P W J

    2006-12-20

    Options for intervention against Mycobacterium tuberculosis infection are limited by the diagnostic tools available. The Purified Protein Derivative (PPD) skin test is thought to be non-specific, especially in tropical settings. We compared the PPD skin test with an ELISPOT test in The Gambia. Household contacts over six months of age of sputum smear positive TB cases and community controls were recruited. They underwent a PPD skin test and an ELISPOT test for the T cell response to PPD and ESAT-6/CFP10 antigens. Responsiveness to M. tuberculosis exposure was analysed according to sleeping proximity to an index case using logistic regression. 615 household contacts and 105 community controls were recruited. All three tests assessed increased significantly in positivity with increasing M. tuberculosis exposure, the PPD skin test most dramatically (OR 15.7; 95% CI 6.6-35.3). While the PPD skin test positivity continued to trend downwards in the community with increasing distance from a known case (61.9% to 14.3%), the PPD and ESAT-6/CFP-10 ELISPOT positivity did not. The PPD skin test was more in agreement with ESAT-6/CFP-10 ELISPOT (75%, p = 0.01) than the PPD ELISPOT (53%, p<0.0001). With increasing M. tuberculosis exposure, the proportion of ESAT-6/CFP-10 positive contacts who were PPD skin test positive increased (p<0.0001), and the proportion of ESAT-6/CFP-10 negative contacts that were PPD skin test negative decreased (p<0.0001); the converse did not occur. The PPD skin test has surprisingly high specificity for M. tuberculosis infection from recent exposure in The Gambia. In this setting, anti-tuberculous prophylaxis in PPD skin test positive individuals should be revisited.

  9. Evaluation of autologous serum skin test and skin prick test reactivity to house dust mite in patients with chronic spontaneous urticaria.

    PubMed

    Song, Zhiqiang; Zhai, Zhifang; Zhong, Hua; Zhou, Ziyuan; Chen, WenChieh; Hao, Fei

    2013-01-01

    Chronic spontaneous urticaria (CSU) is a common skin disorder with etiology that is not well understood. In this study, we evaluated the prevalence of autologous serum skin test (ASST) and skin prick testing (SPT) to house dust mite (HDM) in 862 CSU cases in China. Clinical features, courses and treatment responses were also recorded. The prevalence of positive ASST was 46.3%, and patients aged 30-39 years had the highest positive rate (52.1%). Positive SPT to HDM was seen in 153 patients (17.7%) with the highest positive rate (34.2%) in patients aged 20 or less. Patients with positive ASST had higher urticaria activity scores (UAS) (4.18±0.65 vs. 3.67±0.53) but lower positive rates of HDM (24.6% vs. 37.6%), as compared with those with negative ASST (odds ratio (OR) 1.84, 95% CI 1.38-2.47). Patients could be categorized into four groups based on the results of ASST and SPT to HDM and patients with positive ASST and positive SPT to HDM had the highest disease activity scores, experienced higher frequencies of angioedema, diseases duration, and required higher dosage of loratadine every month, compared with other subgroups (P<0.0001). Patients with CSU showed varied responses of positive ASST and varied sensitivity to HDM, Patients with positive ASST and/or positive SPT had more disease activity compared with patients with negative ASST and/or negative SPT. Further classification can be made based on the result of SPT and ASST.

  10. Evaluation of Autologous Serum Skin Test and Skin Prick Test Reactivity to House Dust Mite in Patients with Chronic Spontaneous Urticaria

    PubMed Central

    Song, Zhiqiang; Zhai, Zhifang; Zhong, Hua; Zhou, Ziyuan; Chen, WenChieh; Hao, Fei

    2013-01-01

    Background Chronic spontaneous urticaria (CSU) is a common skin disorder with etiology that is not well understood. Methods In this study, we evaluated the prevalence of autologous serum skin test (ASST) and skin prick testing (SPT) to house dust mite (HDM) in 862 CSU cases in China. Clinical features, courses and treatment responses were also recorded. Results The prevalence of positive ASST was 46.3%, and patients aged 30–39 years had the highest positive rate (52.1%). Positive SPT to HDM was seen in 153 patients (17.7%) with the highest positive rate (34.2%) in patients aged 20 or less. Patients with positive ASST had higher urticaria activity scores (UAS) (4.18±0.65 vs. 3.67±0.53) but lower positive rates of HDM (24.6% vs. 37.6%), as compared with those with negative ASST (odds ratio (OR) 1.84, 95% CI 1.38–2.47). Patients could be categorized into four groups based on the results of ASST and SPT to HDM and patients with positive ASST and positive SPT to HDM had the highest disease activity scores, experienced higher frequencies of angioedema, diseases duration, and required higher dosage of loratadine every month, compared with other subgroups (P<0.0001). Conclusions Patients with CSU showed varied responses of positive ASST and varied sensitivity to HDM, Patients with positive ASST and/or positive SPT had more disease activity compared with patients with negative ASST and/or negative SPT. Further classification can be made based on the result of SPT and ASST. PMID:23741306

  11. Factors associated with negative histamine control for penicillin allergy skin testing in the inpatient setting.

    PubMed

    Geng, Bob; Thakor, Ami; Clayton, Elisabeth; Finkas, Lindsay; Riedl, Marc A

    2015-07-01

    Identification of factors adversely affecting the utility of allergy skin testing is important in optimizing patient care. Inpatient penicillin skin test data from 1997 through 2007 demonstrate that up to 20% of attempted penicillin skin tests are indeterminate owing to a negative histamine test response, despite exclusion of H1 antagonists. Critical illness, vasopressors, steroid use, and psychotropic medications have been postulated to influence outcomes, but large studies are lacking. To identify factors associated with a negative histamine test response for the inpatient setting. Fifty-two cases were identified with a negative histamine response after penicillin skin testing in the absence of antihistamine therapy for 72 hours before testing. One hundred twenty-five controls with a normal histamine response were randomly selected from same population. Independent variables assessed included stay in the intensive care unit (ICU), skin color, diabetes, age, use of vasopressors, H2 blocker, steroids, other immunosuppressive drugs, thyroid replacement, proton pump inhibitors, diuretics, 5 categories of psychotropic medications, and amiodarone. Mean age was 68 years for cases vs 60 years for controls (P = .002). Bivariate analysis showed ICU stay was more frequent in cases than in controls (73.1% vs 33.6%, P < .001). Regression analysis yielded odds ratios (ORs) of 8.18 (95% confidence interval 3.22-20.76) for ICU status, 3.76 (1.30-10.92) for systemic corticosteroids, and 4.90 (1.17-20.62) for H2 blockers as associated with lack of histamine response. For every additional year in age, there was increase in the OR of 1.04 (1.01-1.07). Regression analysis supports ICU stay during skin testing as associated with a high OR for a negative histamine response independent of age. Systemic corticosteroids, H2 blockers, and older age are associated with a significant OR for a negative histamine response. This is one of largest studies on factors associated with a negative

  12. Are allergen batch differences and the use of double skin prick test important?

    PubMed

    Thomsen, Gert F; Schlünssen, Vivi; Skadhauge, Lars R; Malling, Tine Halsen; Sherson, David L; Omland, Øyvind; Sigsgaard, Torben

    2015-04-09

    Skin prick tests (SPT) are widely used both in clinical diagnostics and in research. The standardization of allergen extracts is well documented to be crucial for the validity of SPT, whereas less emphasis has been placed on reproducibility and the SPT procedure itself. The objectives of this study are to clarify how the double skin prick test procedure influence the sensitivity and specificity of the test and to analyse the differences in weal size in skin prick tests between two batches of allergen extracts from the same vendor. The association between rhinitis and SPT was assessed among 1135 persons from a general population sample. SPT was performed twice with 10 common aeroallergens. In a subsample of 90 persons SPT was performed simultaneously with five of the allergens using different batches. Thirty percent had at least one positive SPT. Among asthmatics this number was 62%. Only minor differences were seen between the sizes of two weals from the same batch. A second SPT with the same batch did not change the association between rhinitis and sensitization. When performing SPT with two different batches disagreement was observed in 2% (Birch) to 11% (Cat) of the subjects. Performing SPT twice with the same allergen batch does not enhance the validity of the test, and value of double testing can be questioned. Considerable differences in SPT response with different batches from the same manufacturer were observed. Thus inter batch differences in allergen extracts might be a source of variability.

  13. Correlates of Irritability in College Students With Depressive Symptoms

    PubMed Central

    Pedrelli, Paola; Nyer, Maren; Holt, Daphne; Bakow, Brianna R.; Fava, Maurizio; Baer, Lee; Cassiello, Clair; Mulligan, Maura; Cusin, Cristina; Farabaugh, Amy

    2015-01-01

    Depression is a prevalent psychiatric disorder associated with significant personal and societal burden. There is accumulating evidence for the presence of a subtype of depression characterized by the presence of irritability that is associated with increased morbidity, risk for suicidal ideation, and functional impairments in adults. Little is known about the features of depressive symptoms with and without irritability among young adults in college. The primary aim of this study was to characterize the presentation of college students with depressive symptoms and irritability. Two-hundred eighty-seven undergraduate college students with depressive symptoms with and without irritability were compared across several psychiatric and functional outcome variables. Independent samples t-tests or logistic regressions were conducted for each outcome variable using the irritability item of the Beck Depression Inventory as a dichotomous grouping variable. Analyses were conducted separately for the men and the women. Both male and female students with depressive symptoms and severe irritability reported a greater severity of depressive symptoms compared with their peers with no or mild irritability. In the women, the presence of irritability was associated with greater symptoms of anxiety, whereas in the men, it was associated with increased likelihood of engaging in risky behaviors, including compulsive use of alcohol, illicit drugs, and prescription drugs. The male and female college students with depressive symptoms with and without irritability did not differ on severity of suicidal ideation, hopelessness, or cognitive functioning. The findings from this study suggest that depressive symptoms and irritability may characterize a subtype of college students who have a greater symptom burden and with the potential need for more aggressive and prompt treatment. PMID:24177482

  14. Occupational irritant contact dermatitis diagnosed by analysis of contact irritants and allergens in the work environment.

    PubMed

    Friis, Ulrik F; Menné, Torkil; Schwensen, Jakob F; Flyvholm, Mari-Ann; Bonde, Jens P E; Johansen, Jeanne D

    2014-12-01

    Irritant contact dermatitis (ICD) is a common diagnosis in patients with occupational contact dermatitis (OCD). Studies are lacking on the usefulness of material safety data sheets (MSDSs) in making the diagnosis of ICD. To characterize irritant exposures leading to the diagnosis of occupational ICD (OICD), and to evaluate the occurrence of concomitant exposures to contact allergens. We included 316 patients with suspected occupational hand dermatitis, referred to the Department of Dermato-Allergology, Copenhagen University Hospital Gentofte, Denmark during January 2010-August 2011, in a programme consisting of a clinical examination, exposure assessment, and extensive patch/prick testing. OCD was diagnosed in 228 patients. Of these patients, 118 were diagnosed with OICD. The main irritant exposures identified were wet work (n = 64), gloves (n = 45), mechanical traumas (n = 19), and oils (n = 15). Exposure to specific irritant chemicals was found in 9 patients, and was identified from MSDSs/ingredients labelling in 8 of these patients. Review of MSDSs and ingredients labelling showed that 41 patients were exposed to 41 moderate to potent contact allergens, and 18 patients were exposed to 25 weak workplace contact allergens. In the present study, the systematic exposure assessment did not reveal any new irritants. MSDSs have a limited role in the investigation of ICD. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Comparative Evaluation of a Silicone Membrane as an Alternative to Skin for Testing Mosquito Repellents.

    PubMed

    Agramonte, Natasha M; Gezan, Salvador A; Bernier, Ulrich R

    2017-05-01

    Repellents prevent mosquito bites and help reduce mosquito-borne disease, a global public health issue. Laboratory-based repellent bioassays predict the ability of compounds to deter mosquito feeding, but the variety of repellent bioassays and statistical analysis methods makes it difficult to compare results across methodologies. The most realistic data are collected when repellents are applied on the skin; however, this method exposes volunteers to chemicals and mosquito bites. Silicone membranes were investigated as an alternative to human skin in assays of repellent efficacy. Results from module system bioassays conducted in vitro with a silicone membrane were compared with in vivo bioassays conducted with N,N-diethyl-3-methylbenzamide (referred to as DEET), 1-piperidinecarboxylic acid 2-(2-hydroxyethyl)-1-methylpropylester (referred to as Picaridin), ethyl 3-[acetyl(butyl)amino]propanoate (referred to as IR3535), and para-menthane-3,8-diol (referred to as PMD) applied directly on the skin of the leg. No significant difference in mosquito feeding was found when comparing skin and volunteer-worn membrane controls using blood; however, feeding was significantly lower in unworn membrane controls using either 10% sucrose or blood, indicating that worn membranes are a possible surrogate for untreated human skin. Pooled data from six volunteers were used to generate dose-response curves of blood-feeding activity. Results from skin-applied repellents were modeled to determine if membranes could provide a predictive correlate for skin. Goodness-of-fit comparisons indicated that the nonlinear dose-response curves for the skin and membrane differed significantly for DEET and Picaridin, but did not differ significantly for IR3535 and PMD. With knowledge of the dose-response relationships and further modifications to this system, the membrane-based tests could be used for standardized repellent testing with infected vectors. Published by Oxford University Press on behalf

  16. American cutaneous leishmaniasis: use of a skin test as a predictor of relapse after treatment.

    PubMed Central

    Passos, V. M.; Barreto, S. M.; Romanha, A. J.; Krettli, A. U.; Volpini, A. C.; Lima e Costa, M. F.

    2000-01-01

    While relapses following clinical cure of American cutaneous leishmaniasis are frequent, no test has been described until now to predict such relapses. A cohort of 318 American cutaneous leishmaniasis patients was followed up for two years after treatment with meglumine antimoniate, during which time 32 relapses occurred, 30 in the first year and two in the second (accumulated risk: 10.5%). No association was found between these relapses and the parasite-specific antibody response before and after treatment, or between the relapses and stratification by sociodemographic and clinical characteristics. However when Leishmania was used as antigen, patients with a negative skin test at the time of diagnosis presented a 3.4-fold higher risk (hazard risk = 3.4; 95% confidence interval, 1.7-7.0) of American cutaneous leishmaniasis relapse, compared with patients with a positive response. This result shows that the skin test can be a predictor of American cutaneous leishmaniasis relapse after treatment. PMID:10994280

  17. Testing and Analysis of Composite Skin/Stringer Debonding Under Multi-Axial Loading

    NASA Technical Reports Server (NTRS)

    Krueger, Ronald; Cvitkovich, Michael K.; O'Brien, T. Kevin; Minguet, Pierre J.

    2000-01-01

    A consistent step-wise approach is presented to investigate the damage mechanism in composite bonded skin/stringer constructions under uniaxial and biaxial (in-plane/out-of-plane) loading conditions. The approach uses experiments to detect the failure mechanism, computational stress analysis to determine the location of first matrix cracking and computational fracture mechanics to investigate the potential for delamination growth. In a first step, tests were performed on specimens, which consisted of a tapered composite flange, representing a stringer or frame, bonded onto a composite skin. Tests were performed under monotonic loading conditions in tension, three-point bending, and combined tension/bending to evaluate the debonding mechanisms between the skin and the bonded stringer. For combined tension/bending testing, a unique servohydraulic load frame was used that was capable of applying both in-plane tension and out-of-plane bending loads simultaneously. Specimen edges were examined on the microscope to document the damage occurrence and to identify typical damage patterns. For all three load cases, observed failure initiated in the flange, near the flange tip, causing the flange to almost fully debond from skin. In a second step, a two dimensional plane-strain finite element model was developed to analyze the different test cases using a geometrically nonlinear solution. For all three loading conditions, computed principal stresses exceeded the transverse strength of the material in those areas of the flange where the matrix cracks had developed during the tests. In a third step, delaminations of various lengths were simulated in two locations where delaminations were observed during the tests. The analyses showed that at the loads corresponding to matrix ply crack initiation computed strain energy release rates exceeded the values obtained from a mixed mode failure criterion in one location, Hence. Unstable delamination propagation is likely to occur as

  18. Testing and Analysis of Composite Skin/Stringer Debonding under Multi-Axial Loading

    NASA Technical Reports Server (NTRS)

    Krueger, Ronald; Cvitkovich, Michael; OBrien, Kevin; Minguet, Pierre J.

    2000-01-01

    A consistent step-wise approach is presented to investigate the damage mechanism in composite bonded skin/stringer constructions under uniaxial and biaxial (in-plane/out-of-plane) loading conditions. The approach uses experiments to detect the failure mechanism, computational stress analysis to determine the location of first matrix cracking and computational fracture mechanics to investigate the potential for delamination growth. In a first step, tests were performed on specimens, which consisted of a tapered composite flange, representing a stringer or frame, bonded onto a composite skin. Tests were performed under monotonic loading conditions in tension, three-point bending, and combined tension/bending to evaluate the debonding mechanisms between the skin and the bonded stringer. For combined tension/bending testing, a unique servohydraulic load frame was used that was capable of applying both in-plane tension and out-of-plane bending loads simultaneously. Specimen edges were examined on the microscope to document the damage occurrence and to identify typical damage patterns. For all three load cases, observed failure initiated in the flange, near the flange tip, causing the flange to almost fully debond from the skin. In a second step, a two-dimensional plane-strain finite element model was developed to analyze the different test cases using a geometrically nonlinear solution. For all three loading conditions, computed principal stresses exceeded the transverse strength of the material in those areas of the flange where the matrix cracks had developed during the tests. In a third step, delaminations of various lengths were simulated in two locations where delaminations were observed during the tests. The analyses showed that at the loads corresponding to matrix ply crack initiation computed strain energy release rates exceeded the values obtained from a mixed mode failure criterion in one location. Hence, unstable delamination propagation is likely to occur as

  19. Tribological testing of skin products: gender, age, and ethnicity on the volar forearm.

    PubMed

    Sivamani, Raja K; Wu, Gabriel C; Gitis, Norm V; Maibach, Howard I

    2003-11-01

    Few studies have focused on the simultaneous measurement of the friction and electrical properties of skin. This work investigates the feasibility of using these measurements to differentiate between the effects of chemicals commonly applied to the skin. In addition, this study also compares the condition of the skin and its response to application of chemicals across gender, ethnicity, and age at the volar forearm. Friction and electrical tests were performed on 59 healthy volunteers with the UMT Series Micro-Tribometer (UMT). A 13-mm-diameter copper cylindrical friction/electrical probe was pressed onto the skin with a weight of 20 g and moved across the skin at a constant velocity of 0.4 mm/s. Each volunteer served as his or her own control. The friction and electrical impedance measurements were performed for polyvinylidene chloride occlusion and for the application of glycerin and petrolatum. No differences were found across age, gender, or ethnicity at the volar forearm. Polyvinylidene chloride (PVDC) occlusion showed a small increase in the friction and a small decrease in the electrical impedance; petrolatum increased the friction by a greater amount but its effect on the impedance was comparable to PVDC occlusion; glycerin increased the friction by an amount comparable to petrolatum, but it decreased the impedance to a much greater degree than petrolatum or the PVDC occlusion. An amplitude/mean measurement of the friction curves of glycerin and petrolatum showed that glycerin has a significantly higher amplitude/mean than petrolatum. The properties of the volar forearm appear to be independent of age, gender, and ethnicity. Also, the simultaneous measurement of friction and electrical impedance was useful in differentiating between compounds administered to the skin.

  20. Instability of delayed-type hypersensitivity skin test anergy in human immunodeficiency virus infection.

    PubMed

    Caiaffa, W T; Graham, N M; Galai, N; Rizzo, R T; Nelson, K E; Vlahov, D

    1995-10-23

    To evaluate stability of delayed-type hypersensitivity (DTH) skin test over time in human immunodeficiency virus (HIV)-seropositive and HIV-seronegative injecting drug users. A community-based cohort of injecting drug users who had serial skin testing with purified protein derivative tuberculin, mumps, and Candida albicans antigen. Delayed-type hypersensitivity anergy was defined as a skin test result of less than 3 mm for all three antigens; DTH positivity was a skin test result of 3 mm or greater for at least one antigen (Centers for Disease Control and Prevention, Atlanta, Ga, 1993). At baseline, 36% of HIV-seropositive subjects (n = 401) were anergic as compared with 14% of HIV-seronegative subjects (n = 552; P < .001). During follow-up, fewer HIV-seropositive subjects remained DTH positive (42%) and more remained anergic (19%) than of HIV-seronegative subjects (67% and 7%, respectively). Twenty-four percent of HIV-seropositive subjects who were initially DTH positive became anergic as compared with 15.3% of the HIV-seronegative subjects. However, the proportion changing from anergy to DTH positivity was greater among HIV-seropositive subjects (15%) than HIV-seronegative subjects (12%). In comparison to those who remained DTH positive, HIV-seropositive subjects with CD4 cell counts of less than 0.50 x 10(9)/L (odds ratio = 6.4) and less than 0.35 x 10(9)/L (odds ratio = 11.2) were more likely to remain anergic than those who had CD4 cell counts above 0.50 x 10(9)/L or were HIV seronegative. Although the prevalence and incidence of DTH anergy were higher in HIV-seropositive subjects, high rates of change in DTH status occurred in both directions. This suggests that instability of DTH skin testing is substantial and only partially dependent on HIV status. Although a single test may be an unreliable indicator of HIV-induced immunosuppression, two consecutive anergic readings were strongly associated with a CD4 cell count below 0.50 x 10(9)/L and particularly below

  1. The value of Tzanck smear test in diagnosis of erosive, vesicular, bullous, and pustular skin lesions.

    PubMed

    Durdu, Murat; Baba, Mete; Seçkin, Deniz

    2008-12-01

    Tzanck smear is generally used for the diagnosis of the pemphigus group of autoimmune bullous diseases and mucocutaneous herpesvirus infections. There are only a few studies in the literature investigating its diagnostic value. We aimed to investigate Tzanck smear findings and to determine the diagnostic value of this test in moist (erosive, vesicular, bullous, and pustular) skin lesions. We also aimed to develop an algorithmic approach for the diagnosis of these types of skin lesions according to the Tzanck smear findings. Samples were stained with May-Grünwald-Giemsa and evaluated by the same dermatologist. In some patients, methylene blue and Gram staining or direct immunofluorescence examinations were additionally performed. In all of the study cases, after the evaluation of clinical and laboratory findings (including, when appropriate, potassium hydroxide examination; viral serology; bacterial and fungal cultures; histopathology; direct and indirect immunofluorescence; patch testing), the definite diagnosis was established. We also determined the sensitivity and the specificity of certain Tzanck smear findings. Tzanck smear was performed in a total of 400 patients with moist skin lesions. The sensitivities of multinucleated giant cells and acantholytic cells in herpetic infections, dyskeratotic acantholytic cells and cocci in bullous impetigo, pseudohyphae in candidiasis, acantholytic cells in pemphigus and more than 10 tadpole cells (magnification x100) in spongiotic dermatitis were 84.7%, 92%, 100%, 100%, and 81.5%, respectively. Because Tzanck smears were evaluated by the same dermatologist, no comment could be made regarding the interobserver reliability of this test and how the level of experience with this technique might affect the results. Also, the sensitivity and the specificity of Tzanck smear test findings for certain diseases could not be calculated because of an insufficient number of patients. The Tzanck smear test is an inexpensive, useful

  2. Assuring consumer safety without animal testing: a feasibility case study for skin sensitisation.

    PubMed

    Maxwell, Gavin; Aleksic, Maja; Aptula, Aynur; Carmichael, Paul; Fentem, Julia; Gilmour, Nicola; Mackay, Cameron; Pease, Camilla; Pendlington, Ruth; Reynolds, Fiona; Scott, Daniel; Warner, Guy; Westmoreland, Carl

    2008-11-01

    Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. 'omics', informatics), leading to the development of new non-animal (in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study. 2008 FRAME.

  3. Skin-prick testing as a diagnostic aid for childhood asthma.

    PubMed

    Chan, E Y; Dundas, I; Bridge, P D; Healy, M J R; McKenzie, S A

    2005-06-01

    Diagnosing asthma is problematic when based solely on reported symptoms. The purpose of this study was to evaluate skin-prick testing as a diagnostic aid for asthma in children. Skin-prick testing (SPT) was undertaken in children aged 2-10 years with either no history of wheeze (n = 149) or recent doctor-observed wheeze which responded to treatment with a bronchodilator, the "gold standard" (n = 164). Children with moderate or severe asthma were excluded. SPT positivity increased sharply at age 5 years in wheezers. Data were therefore divided into two age groups: 2- < 5 years (57 controls, 97 wheezers) and 5-10 years (92 controls, 67 wheezers). The sensitivity, specificity, and likelihood ratios of SPT positivity for wheeze were 32%, 89%, and 2.9, respectively, in the younger children, and 82%, 85%, and 5.5, respectively, in the older children. For a prevalence of 30% for asthma, the positive predictive values of a positive SPT were 55% and 70% for the younger and older age groups, respectively. The test characteristics of SPT for helping diagnose asthma in schoolchildren are good. The prevalence of wheeze in preschool children is high, and so SPT should be helpful even in this group. We suggest that clinicians consider skin-prick testing as a diagnostic aid for asthma. Copyright 2005 Wiley-Liss, Inc.

  4. Povidone-iodine induced post-surgical irritant contact dermatitis localized outside of the surgical incision area. Report of 27 cases and a literature review.

    PubMed

    Borrego, Leopoldo; Hernández, Noelia; Hernández, Zaida; Peñate, Yeray

    2016-05-01

    Povidone-iodine solution is an antiseptic that is used worldwide as surgical paint and is considered to have a low irritant potential. Post-surgical severe irritant dermatitis has been described after the misuse of this antiseptic in the surgical setting. Between January 2011 and June 2013, 27 consecutive patients with post-surgical contact dermatitis localized outside of the surgical incision area were evaluated. Thirteen patients were also available for patch testing. All patients developed dermatitis the day after the surgical procedure. Povidone-iodine solution was the only liquid in contact with the skin of our patients. Most typical lesions were distributed in a double lumbar parallel pattern, but they were also found in a random pattern or in areas where a protective pad or an occlusive medical device was glued to the skin. The patch test results with povidone-iodine were negative. Povidone-iodine-induced post-surgical dermatitis may be a severe complication after prolonged surgical procedures. As stated in the literature and based on the observation that povidone-iodine-induced contact irritant dermatitis occurred in areas of pooling or occlusion, we speculate that povidone-iodine together with occlusion were the causes of the dermatitis epidemic that occurred in our surgical setting. Povidone-iodine dermatitis is a problem that is easily preventable through the implementation of minimal routine changes to adequately dry the solution in contact with the skin. © 2015 The International Society of Dermatology.

  5. Increased Sensitization to Mold Allergens Measured by Intradermal Skin Testing following Hurricanes

    PubMed Central

    Hurst, David

    2017-01-01

    Objective. To report on changes in sensitivity to mold allergens determined by changes in intradermal skin testing reactivity, after exposure to two severe hurricanes. Methods. A random, retrospective allergy charts review divided into 2 groups of 100 patients each: Group A, patients tested between 2003 and 2010 prior to hurricanes, and Group B, patients tested in 2014 and 2015 following hurricanes. Reactivity to eighteen molds was determined by intradermal skin testing. Test results, age, and respiratory symptoms were recorded. Chi-square test determined reactivity/sensitivity differences between groups. Results. Posthurricane patients had 34.6 times more positive results (p < 0.0001) at weaker dilutions, all tested molds were found to be more reactive, and 95% had at least one positive test versus only 62% before the hurricanes (p < 0.0001); average mold reactivity was 55% versus 16% while 17% of patients reacted to the entire panel versus none before the hurricanes (p < 0.0001). The posthurricane population was younger (p < 0.001) and included more patients with asthma or lower respiratory symptoms (p < 0.05). Conclusion. Reactivity and sensitization to mold allergens increased compared to patients before the hurricanes. This supports climatologists' hypothesis that environmental changes resulting from hurricanes can be a health risk as reflected in increased allergic sensitivities and symptoms and has significant implications for physicians treating patients from affected areas. PMID:28491100

  6. Increased Sensitization to Mold Allergens Measured by Intradermal Skin Testing following Hurricanes.

    PubMed

    Saporta, Diego; Hurst, David

    2017-01-01

    Objective . To report on changes in sensitivity to mold allergens determined by changes in intradermal skin testing reactivity, after exposure to two severe hurricanes. Methods . A random, retrospective allergy charts review divided into 2 groups of 100 patients each: Group A, patients tested between 2003 and 2010 prior to hurricanes, and Group B, patients tested in 2014 and 2015 following hurricanes. Reactivity to eighteen molds was determined by intradermal skin testing. Test results, age, and respiratory symptoms were recorded. Chi-square test determined reactivity/sensitivity differences between groups. Results . Posthurricane patients had 34.6 times more positive results ( p < 0.0001) at weaker dilutions, all tested molds were found to be more reactive, and 95% had at least one positive test versus only 62% before the hurricanes ( p < 0.0001); average mold reactivity was 55% versus 16% while 17% of patients reacted to the entire panel versus none before the hurricanes ( p < 0.0001). The posthurricane population was younger ( p < 0.001) and included more patients with asthma or lower respiratory symptoms ( p < 0.05). Conclusion . Reactivity and sensitization to mold allergens increased compared to patients before the hurricanes. This supports climatologists' hypothesis that environmental changes resulting from hurricanes can be a health risk as reflected in increased allergic sensitivities and symptoms and has significant implications for physicians treating patients from affected areas.

  7. Opiate-sensitivity: clinical characteristics and the role of skin prick testing.

    PubMed

    Nasser, S M; Ewan, P W

    2001-07-01

    The value of skin prick testing in opiate-sensitive individuals is uncertain as opiates cause non-specific weals by direct degranulation of mast cells. To define whether skin prick test (SPT) responses to opiates in opiate-sensitive individuals are different to those seen in the normal population and to describe the clinical characteristics of this group of subjects. The SPT responses of eight opiate-sensitive subjects to morphine 10 mg/mL, pethidine (meperidine) 50 mg/mL and papaveretum 15.4 mg/mL at four different concentrations (undiluted, 1/10, 1/50 and 1/100) were compared with the responses of 100 (32 atopic) non-opiate-sensitive control subjects. Four of the opiate-sensitive subjects had a clinical history of asthma, rhinitis or urticaria on occupational exposure to morphine. One subject developed urticaria with codeine, one developed urticaria and asthma with morphine and diamorphine and two subjects reacted to intravenous papaveretum with anaphylaxis or urticaria. Five out of the eight cases had opiate sensitivity confirmed by single-blind placebo-controlled oral challenge. Skin prick tests to all three opiates were not significantly different when the eight opiate-sensitive subjects were compared with either the entire normal control group or the subgroup of 47 definite opiate-tolerant controls that had previously received opiates for clinical indications. Furthermore, there were no significant differences in size of opiate SPT responses between atopic and non-atopic control subjects. In the control subjects, there was a positive correlation in SPT weal size between the three opiates. Skin prick testing is not useful in the diagnosis of opiate sensitivity and placebo-controlled challenge should be considered.

  8. A clinical decision support system for diagnosis of Allergic Rhinitis based on intradermal skin tests.

    PubMed

    Jabez Christopher, J; Khanna Nehemiah, H; Kannan, A

    2015-10-01

    Allergic Rhinitis is a universal common disease, especially in populated cities and urban areas. Diagnosis and treatment of Allergic Rhinitis will improve the quality of life of allergic patients. Though skin tests remain the gold standard test for diagnosis of allergic disorders, clinical experts are required for accurate interpretation of test outcomes. This work presents a clinical decision support system (CDSS) to assist junior clinicians in the diagnosis of Allergic Rhinitis. Intradermal Skin tests were performed on patients who had plausible allergic symptoms. Based on patient׳s history, 40 clinically relevant allergens were tested. 872 patients who had allergic symptoms were considered for this study. The rule based classification approach and the clinical test results were used to develop and validate the CDSS. Clinical relevance of the CDSS was compared with the Score for Allergic Rhinitis (SFAR). Tests were conducted for junior clinicians to assess their diagnostic capability in the absence of an expert. The class based Association rule generation approach provides a concise set of rules that is further validated by clinical experts. The interpretations of the experts are considered as the gold standard. The CDSS diagnoses the presence or absence of rhinitis with an accuracy of 88.31%. The allergy specialist and the junior clinicians prefer the rule based approach for its comprehendible knowledge model. The Clinical Decision Support Systems with rule based classification approach assists junior doctors and clinicians in the diagnosis of Allergic Rhinitis to make reliable decisions based on the reports of intradermal skin tests. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. Sensitization to Food Additives in Patients with Allergy: A Study Based on Skin Test and Open Oral Challenge.

    PubMed

    Moghtaderi, Mozhgan; Hejrati, Zinatosadat; Dehghani, Zahra; Dehghani, Faranak; Kolahi, Niloofar

    2016-06-01

    There has been a great increase in the consumption of various food additives in recent years. The purpose of this study was to identify the incidence of sensitization to food additives by using skin prick test in patients with allergy and to determine the concordance rate between positive skin tests and oral challenge in hypersensitivity to additives. This cross-sectional study included 125 (female 71, male 54) patients aged 2-76 years with allergy and 100 healthy individuals. Skin tests were performed in both patient and control groups with 25 fresh food additives. Among patients with allergy, 22.4% showed positive skin test at least to one of the applied materials. Skin test was negative to all tested food additives in control group. Oral food challenge was done in 28 patients with positive skin test, in whom 9 patients showed reaction to culprit (Concordance rate=32.1%). The present study suggested that about one-third of allergic patients with positive reaction to food additives showed positive oral challenge; it may be considered the potential utility of skin test to identify the role of food additives in patients with allergy.

  10. Cutaneous irritancy of an ibuprofen medicated plaster in healthy volunteers.

    PubMed

    Maganji, Manisha; Connolly, Mark P; Bhatt, Aomesh

    2018-01-01

    Ibuprofen is a commonly used non-steroidal anti-inflammatory drug administered to treat injuries, joint pain, and recurrent muscular skeletal pain. The aim of this study was to determine the cutaneous irritancy of a medicated ibuprofen plaster compared with a placebo plaster in healthy volunteers. Healthy volunteers (N = 31) were treated at the same time with one ibuprofen and one placebo plaster. The ibuprofen and placebo plaster were applied in a randomized fashion to sites on the left or right side of subjects' lower backs. At each scheduled visit, the plasters and applications sites were assessed for degree of adhesion and skin irritancy, respectively. The plasters were applied on study Days 1, 2, 3, 5, 8, 10, 12, 15, 17, and 19, with final plaster removal on Day 22. The ibuprofen medicated plaster compared with placebo had a lower percentage of Grade 1 (23.3% vs. 46.7%, respectively), Grade 2 (10% vs. 20%), and ≥Grade 3 (3% vs. 16.1%) irritancy scores after 21 days of application. The mean irritation score across the study was 0.40 for the ibuprofen medicated plaster and 1.18 for the placebo plaster. The irritation score on Day 22 of the study was 0.53 for the ibuprofen medicated plaster and 1.50 for placebo. The placebo plaster was associated with a higher number of stopped applications due to Grade 3 or above skin reactions compared with the ibuprofen medicated plaster (5 vs. 1, respectively). The ibuprofen medicated plaster was well tolerated and was associated with lower irritancy than the placebo plaster.

  11. Evaluation of self-reported skin problems among workers exposed to toluene diisocyanate (TDI) at a foam manufacturing facility.

    PubMed

    Daftarian, Helga S; Lushniak, Boris D; Reh, Christopher M; Lewis, Daniel M

    2002-12-01

    Toluene diisocyanate, or TDI (CAS 584-84-9) is a well-known asthmagen and respiratory irritant. TDI is also known for its ability to irritate the skin and mucous membranes. To further investigate the dermal effects of TDI, NIOSH investigators conducted a cross-sectional study at a flexible foam manufacturing plant. A total of 114 workers participated in the study. Participants completed a medical questionnaire, provided blood for antibody testing to TDI and other allergens, and a subset of participants reporting skin symptoms underwent skin patch testing to a standard diisocyanate panel. Production line workers were more than twice as likely to report skin problems as those working in nonproduction areas (PRR = 2.66; 95% CI = 1.14-16.32; P = 0.02). Age, gender and duration of employment at the plant were comparable among participants working in production and nonproduction areas. Of the 100 participants who provided blood samples for antibody testing, specific IgG antibody to TDI was detected in two individuals, and none of the samples demonstrated specific IgE antibody to TDI. Of the 26 workers who underwent skin patch testing, none developed reactions to the diisocyanate allergens. These results suggest that the skin symptoms among study participants represent an irritant rather than an immunologic reaction to TDI, or to an unidentified allergen present in the foam.

  12. Tests of Flammability of Cotton Fabrics and Expected Skin Burns in Microgravity

    NASA Technical Reports Server (NTRS)

    Cavanagh, Jane M.; Torvi, David A.; Gabriel, Kamiel S.; Ruff, Gary A.

    2004-01-01

    During a shuttle launch and other portions of space flight, astronauts wear specialized flame resistant clothing. However during most of their missions on board the Space Shuttle or International Space Station, astronauts wear ordinary clothing, such as cotton shirts and pants. As the behaviour of flames is considerably different in microgravity than under earth's gravity, fabrics are expected to burn in a different fashion in microgravity than when tested on earth. There is interest in determining how this change in burning behaviour may affect times to second and third degree burn of human skin, and how the results of standard fabric flammability tests conducted under earth's gravity correlate with the expected fire behaviour of textiles in microgravity. A new experimental apparatus was developed to fit into the Spacecraft Fire Safety Facility (SFSF), which is used on NASA's KC-135 low gravity aircraft. The new apparatus was designed to be similar to the apparatus used in standard vertical flammability tests of fabrics. However, rather than using a laboratory burner, the apparatus uses a hot wire system to ignite 200 mm high by 80 mm wide fabric specimens. Fabric temperatures are measured using thermocouples and/or an infrared imaging system, while flame spread rates are measured using real time observations or video. Heat flux gauges are placed between 7 and 13 mm away from the fabric specimen, so that heat fluxes from the burning fabric to the skin can be estimated, along with predicted times required to produce skin burns. In November of 2003, this new apparatus was used on the KC-135 aircraft to test cotton and cotton/polyester blend fabric specimens in microgravity. These materials were also been tested using the same apparatus in 1-g, and using a standard vertical flammability test that utilizes a flame. In this presentation, the design of the test apparatus will be briefly described. Examples of results from the KC-135 tests will be provided, including

  13. Tests of Flammability of Cotton Fabrics and Expected Skin Burns in Microgravity

    NASA Technical Reports Server (NTRS)

    Cavanagh, Jane M.; Torvi, David A.; Gabriel, Kamiel S.; Ruff, Gary A.

    2004-01-01

    During a shuttle launch and other portions of space flight, astronauts wear specialized flame resistant clothing. However during most of their missions on board the Space Shuttle or International Space Station, astronauts wear ordinary clothing, such as cotton shirts and pants. As the behaviour of flames is considerably different in microgravity than under earth s gravity, fabrics are expected to burn in a different fashion in microgravity than when tested on earth. There is interest in determining how this change in burning behaviour may affect times to second and third degree burn of human skin, and how the results of standard fabric flammability tests conducted under earth s gravity correlate with the expected fire behaviour of textiles in microgravity. A new experimental apparatus was developed to fit into the Spacecraft Fire Safety Facility (SFSF), which is used on NASA s KC-135 low gravity aircraft. The new apparatus was designed to be similar to the apparatus used in standard vertical flammability tests of fabrics. However, rather than using a laboratory burner, the apparatus uses a hot wire system to ignite 200 mm high by 80 mm wide fabric specimens. Fabric temperatures are measured using thermocouples and/or an infrared imaging system, while flame spread rates are measured using real time observations or video. Heat flux gauges are placed between 7 and 13 mm away from the fabric specimen, so that heat fluxes from the burning fabric to the skin can be estimated, along with predicted times required to produce skin burns.

  14. Testing and Analysis of Composite Skin/Stringer Debonding Under Multi-Axial Loading

    NASA Technical Reports Server (NTRS)

    Krueger, Ronald; Cvitkovich, Michael K.; OBrien, T. Kevin; Minguet, Pierre J.

    1999-01-01

    Damage mechanisms in composite bonded skin/stringer constructions under uniaxial and biaxial (in-plane/out- of-plane) loading conditions were examined. Specimens consisted of a tapered composite flange bonded onto a composite skin. Tests were performed under monotonic loading conditions in tension, three-point bending, and combined tension/bending . For combined tension/bending testing, a unique servohydraulic load frame was used that was capable of applying both in-plane tension and out-of-plane bending loads simultaneously. Specimen edges were examined on the microscope to document the damage occurrence and to identify typical damage patterns. The observations showed that, for all three load cases, failure initiated in the flange, near the flange tip, causing the flange to almost fully debond from the skin. A two-dimensional plane-strain finite element model was developed to analyze the different test cases using a geometrically nonlinear solution. For all three loading conditions, principal stresses exceeded the transverse strength of the material in the flange area. Additionally, delaminations of various lengths were simulated in two locations where delaminations were observed. The analyses showed that unstable delamination propagation is likely to occur in one location at the loads corresponding to matrix ply crack initiation for all three load cases.

  15. Ranitidine-induced anaphylaxis: clinical features, cross-reactivity, and skin testing.

    PubMed

    Park, K H; Pai, J; Song, D-G; Sim, D W; Park, H J; Lee, J-H; Jeong, K Y; Pan, C-H; Shin, I; Park, J-W

    2016-04-01

    Histamine H2 receptor antagonists are commonly prescribed medications and are known to be well tolerated. However, 99 cases of ranitidine-induced anaphylaxis occurred in Korea from 2007 to 2014. The purpose of this study was to determine the incidence, clinical features, and diagnostic methods for ranitidine-induced anaphylaxis. Ranitidine-related pharmacovigilance data from 2007 to 2014 were reviewed. Adverse drug reactions with causal relationships were selected, and clinical manifestations, outcomes, and drug-related information were assessed. For further investigation, 8 years of pharmacovigilance data were collected at a single centre. Twenty-three patients participated in in vivo and in vitro studies. Skin tests, oral provocation tests, and laboratory tests were performed, including tests using other kinds of histamine H2 receptor antagonists. Over 7 years, 584 patients suffered adverse reactions to ranitidine. The most common manifestation was cutaneous symptoms. Among them, 99 patients (17.0%) experienced anaphylaxis. In a single-centre study, skin prick tests were positive in 91.7% of ranitidine-induced anaphylaxis patients (11/12); the optimal concentration was 20 mg/mL. Detection of ranitidine-specific immunoglobulin E failed. Cimetidine and proton pump inhibitors showed no cross-reactivity with ranitidine based on the skin prick test, oral provocation test, or clinical determination. Surprisingly, 82.6% of patients reintroduced ranitidine and re-experienced the same adverse reactions because ranitidine was not considered the culprit drug. Although ranitidine is known as a safe drug, it can also cause diverse adverse reactions, including anaphylaxis. This study demonstrates the need to pay attention to adverse reactions to ranitidine and consider ranitidine as a cause of anaphylaxis. © 2016 John Wiley & Sons Ltd.

  16. Retrospective analysis of the Draize test for serious eye damage/eye irritation: importance of understanding the in vivo endpoints under UN GHS/EU CLP for the development and evaluation of in vitro test methods.

    PubMed

    Adriaens, Els; Barroso, João; Eskes, Chantra; Hoffmann, Sebastian; McNamee, Pauline; Alépée, Nathalie; Bessou-Touya, Sandrine; De Smedt, Ann; De Wever, Bart; Pfannenbecker, Uwe; Tailhardat, Magalie; Zuang, Valérie

    2014-03-01

    For more than two decades, scientists have been trying to replace the regulatory in vivo Draize eye test by in vitro methods, but so far only partial replacement has been achieved. In order to better understand the reasons for this, historical in vivo rabbit data were analysed in detail and resampled with the purpose of (1) revealing which of the in vivo endpoints are most important in driving United Nations Globally Harmonized System/European Union Regulation on Classification, Labelling and Packaging (UN GHS/EU CLP) classification for serious eye damage/eye irritation and (2) evaluating the method's within-test variability for proposing acceptable and justifiable target values of sensitivity and specificity for alternative methods and their combinations in testing strategies. Among the Cat 1 chemicals evaluated, 36-65 % (depending on the database) were classified based only on persistence of effects, with the remaining being classified mostly based on severe corneal effects. Iritis was found to rarely drive the classification (<4 % of both Cat 1 and Cat 2 chemicals). The two most important endpoints driving Cat 2 classification are conjunctiva redness (75-81 %) and corneal opacity (54-75 %). The resampling analyses demonstrated an overall probability of at least 11 % that chemicals classified as Cat 1 by the Draize eye test could be equally identified as Cat 2 and of about 12 % for Cat 2 chemicals to be equally identified as No Cat. On the other hand, the over-classification error for No Cat and Cat 2 was negligible (<1 %), which strongly suggests a high over-predictive power of the Draize eye test. Moreover, our analyses of the classification drivers suggest a critical revision of the UN GHS/EU CLP decision criteria for the classification of chemicals based on Draize eye test data, in particular Cat 1 based only on persistence of conjunctiva effects or corneal opacity scores of 4. In order to successfully replace the regulatory in vivo Draize eye test, it will

  17. Development and psychometric testing of the 'Motivation and Self-Efficacy in Early Detection of Skin Lesions' index.

    PubMed

    Dyson, Judith; Cowdell, Fiona

    2014-12-01

    To develop and psychometrically test the Motivation and Self-Efficacy in Early Detection of Skin Lesions Index. Skin cancer is the most frequently diagnosed cancer worldwide. The primary strategy used to prevent skin cancer is promotion of sun avoidance and the use of sun protection. However, despite costly and extensive campaigns, cases of skin cancer continue to increase. If found and treated early, skin cancer is curable. Early detection is, therefore, very important. The study was conducted in 2013. Instrument Development. A literature review and a survey identified barriers (factors that hinder) and levers (factors that help) to skin self-examination. These were categorized according to a the Theoretical Domains Framework and this formed the basis of an instrument, which was tested for validity and reliability using confirmatory factor analysis and Cronbach's alpha respectively. A five-factor 20-item instrument was used that tested well for reliability and construct validity. Test-retest reliability was good for all items and domains. The five factors were: (i) Outcome expectancies; (ii) Intention; (iii) Self-efficacy; (iv) Social influences; (v) Memory. The Motivation and Self-Efficacy in Early Detection of Skin Lesions Index provides a reliable and valid method of assessing barriers and levers to skin self-examination. The next step is to design a theory-based intervention that can be tailored according to individual determinants to behaviour change identified by this instrument. © 2014 John Wiley & Sons Ltd.

  18. Cutaneous Surgical Denervation: A Method for Testing the Requirement for Nerves in Mouse Models of Skin Disease.

    PubMed

    Peterson, Shelby C; Brownell, Isaac; Wong, Sunny Y

    2016-06-26

    Cutaneous somatosensory nerves function to detect diverse stimuli that act upon the skin. In addition to their established sensory roles, recent studies have suggested that nerves may also modulate skin disorders including atopic dermatitis, psoriasis and cancer. Here, we describe protocols for testing the requirement for nerves in maintaining a cutaneous mechanosensory organ, the touch dome (TD). Specifically, we discuss methods for genetically labeling, harvesting and visualizing TDs by whole-mount staining, and for performing unilateral surgical denervation on mouse dorsal back skin. Together, these approaches can be used to directly compare TD morphology and gene expression in denervated as well as sham-operated skin from the same animal. These methods can also be readily adapted to examine the requirement for nerves in mouse models of skin pathology. Finally, the ability to repeatedly sample the skin provides an opportunity to monitor disease progression at different stages and times after initiation.

  19. Irritable bowel syndrome

    PubMed Central

    Enck, Paul; Aziz, Qasim; Barbara, Giovanni; Farmer, Adam D.; Fukudo, Shin; Mayer, Emeran A.; Niesler, Beate; Quigley, Eamonn M. M.; Rajilić-Stojanović, Mirjana; Schemann, Michael; Schwille-Kiuntke, Juliane; Simren, Magnus; Zipfel, Stephan; Spiller, Robin C.

    2016-01-01

    Irritable bowel syndrome (IBS) is a functional gastrointestinal disease with a high population prevalence. The disorder can be debilitating in some patients, whereas others may have mild or moderate symptoms. The most important single risk factors are female sex, younger age and preceding gastrointestinal infections. Clinical symptoms of IBS include abdominal pain or discomfort, stool irregularities and bloating, as well as other somatic, visceral and psychiatric comorbidities. Currently, the diagnosis of IBS is based on symptoms and the exclusion of other organic diseases, and therapy includes drug treatment of the predominant symptoms, nutrition and psychotherapy. Although the underlying pathogenesis is far from understood, aetiological factors include increased epithelial hyperpermeability, dysbiosis, inflammation, visceral hypersensitivity, epigenetics and genetics, and altered brain–gut interactions. IBS considerably affects quality of life and imposes a profound burden on patients, physicians and the health-care system. The past decade has seen remarkable progress in our understanding of functional bowel disorders such as IBS that will be summarized in this Primer. PMID:27159638

  20. Stability and potency of raw and boiled shrimp extracts for skin prick test.

    PubMed

    Pariyaprasert, Wipada; Piboonpocanun, Surapon; Jirapongsananuruk, Orathai; Visitsunthorn, Nualanong

    2015-06-01

    The difference of stability between raw and boiled shrimp extracts used in prick tests has never been investigated despite its potential consequences in tests development. The aim of this study was to compare the raw and boiled shrimp extracts of two species; Macrobrachium rosenbergii (freshwater shrimp) and Penaeus monodon (seawater shrimp) held at 4 ?C for different periods of time for their stability and potency in vivo by using the skin prick test (SPT) method. Raw and boiled M. rosenbergii and P. monodon extracts were prepared and stored at 4 ?C for 1, 7, 14 and 30 days. Thirty patients were pricked with raw and boiled shrimp extracts at all storage times, as well as prick to prick skin test (PTP) to fresh raw and boiled shrimps of both species. The mean wheal diameter (MWD) resulting from prick tests for all shrimp extracts was measured and compared. The shrimp extracts of all storage times yielded positive skin test results in the range of 90% - 100%. Raw P. monodon extracts induced larger wheals than boiled extracts at all storage times. There was no significant difference of MWD between raw and boiled M. rosenbergii extracts on day 1, 7, and 14. Significant correlations between MWD of PTP to fresh shrimps and SPT to all shrimp extracts were observed. All shrimp extracts were sterile at all storage times. Raw and boiled M. rosenbergii and P. monodon extracts were stable and sterile at 4 ?C for at most 30 days. SPT with these extracts induced more than 10 mm in shrimp allergy patients and the results were comparable with PTP to fresh shrimps.

  1. Patients with breakthrough reactions to iodinated contrast media have low incidence of positive skin tests.

    PubMed

    Berti, A; Della-Torre, E; Yacoub, Mr; Tombetti, E; Canti, V; Sabbadini, M G; Colombo, G

    2016-07-01

    The term "breakthrough reactions" designates repeated hypersensitivity reactions to iodinated contrast media (ICM) despite premedication with glucocorticoids and antihistamines. We aimed to retrospectively evaluate the rate of positive skin test (STs) in our cohort of patients with previous breakthrough reactions to different ICMs. A series of 35 patients, who experienced at least one breakthrough reaction to ICM and who underwent STs within 6 months from the reaction were studied, and results were compared to a control group of patients with a first hypersensitivity reaction occurred without premedication. Skin prick tests (SPT), intradermal tests (IDT) and patch tests (PT) at different dilutions, with a set of three to four ICM were performed. Of the 35 patients with prior breakthrough reactions, 57% had an immediate reaction (IR) and 43% had a non-immediate reaction (NIR). Patients who experienced the first hypersensitivity IR or NIR, later had one or more breakthrough IR or NIR, respectively. Overall, 29% (10/35) of patients with prior breakthrough reactions resulted positive to STs compared to 57% (16/28) of the control group (p < 0.05). No significant difference in allergy history, age, sex, other clinical / demographic features nor chronic use of ACE-inhibitor, beta-blockers or NSAIDs was observed. This preliminary finding suggests that patients with prior breakthrough reactions have significantly lower immunologically proven ICM reactions (positive STs) if compared to non-breakthrough patients. According to that, a considerable number of breakthrough reactions seems to be non-allergic hypersensitivity reactions or reactions which could be mostly prevented by a proper, well-timed skin testing. Larger prospective studies are needed to confirm these results, with a more careful analysis of patients' risk factors, a laboratory assessment that includes an in vitro allergy diagnostics, and hopefully a drug provocation test for selected cases.

  2. Penicillin allergy: value of including amoxicillin as a determinant in penicillin skin testing.

    PubMed

    Lin, Erina; Saxon, Andrew; Riedl, Marc

    2010-01-01

    Allergy to penicillins remains an important issue. Penicillin skin testing (PST) with major and minor determinants has been shown to be a highly valuable tool for identifying IgE-mediated penicillin allergy. The value of additional testing with side-chain-specific moieties from semisynthetic penicillins such as amoxicillin is not well-established in spite of the widespread use of these medications. A retrospective review of all consecutive inpatient PST results from 1995 to 2007 comprising 1,068 patients was performed in our institution on individuals with a self-reported history of beta-lactam allergy to assess the importance of including the amoxicillin determinant in a previously validated PST panel. Descriptive statistics were performed. The PST panel included penicilloyl-polylysine, penicillin G, penicilloate, penilloate and amoxicillin. Of 1,068 patients, 243 (23%) had a positive skin test reaction on the PST panel. Testing with amoxicillin was positive in 30.9% of patients, the majority of whom (81%) were also positive to 1 or more standard penicillin reagents. Fourteen of the 243 positive patients (5.8%) had a positive skin test reaction only to amoxicillin. Additionally, the use of penicilloate and penilloate minor determinants in combination with penicillin G identified a greater percentage of penicillin-allergic individuals compared to using only penicillin G (22.6 vs. 6.6%), demonstrating their importance in the PST panel. These data indicate that the inclusion of the amoxicillin determinant appears to identify a small but important group of allergic individuals who may otherwise test negative on a PST panel. Copyright 2010 S. Karger AG, Basel.

  3. A study of the human skin-whitening effects of resveratryl triacetate.

    PubMed

    Ryu, Ja Hyun; Seok, Jin Kyung; An, Sang Mi; Baek, Ji Hwoon; Koh, Jae Sook; Boo, Yong Chool

    2015-04-01

    Resveratrol has a variety of bioactivities that include its anti-melanogenic effects, but its use in cosmetics has been challenging partly because of its chemical instability. Resveratryl triacetate (RTA) is a prodrug that can enhance stability. The purpose of this study was to examine the skin safety and whitening effects of RTA in human subjects. The primary skin irritation potentials of RTA and resveratrol were tested at 0.1 and 0.5 % on human subjects. Resveratrol at a concentration of 0.5 % induced weak skin irritation, whereas RTA did not induce any skin responses. The skin-whitening efficacy of a cosmetic formulation containing 0.4 % RTA was evaluated in two different test models. In the artificial tanning model, the test product and the control product were applied twice daily to the skin of the forearms of 22 human subjects after pigmentation induction by ultraviolet irradiation. Applying the test and the control products to the artificial tanning model for 8 weeks increased the individual topology angles (ITA°) by 17.06 and 13.81 %, respectively, a difference that was statistically significant (p < 0.05). In the hyperpigmentation model, the test product and the control product were applied twice daily to the faces of 21 human subjects. The averaged intensity of the hyperpigmented spots decreased by 2.67 % in the test group and 1.46 % in the control group, a difference that was statistically significant (p < 0.05). Therefore, RTA incorporated into cosmetic formulations can whiten human skin without inducing skin irritation.

  4. Experimental testing and constitutive modeling of the mechanical properties of the swine skin tissue.

    PubMed

    Łagan, Sylwia D; Liber-Kneć, Aneta

    2017-01-01

    The aim of the study was an estimation of the possibility of using hyperelastic material models to fit experimental data obtained in the tensile test for the swine skin tissue. The uniaxial tensile tests of samples taken from the abdomen and back of a pig was carried out. The mechanical properties of the skin such as the mean Young's modulus, the mean maximum stress and the mean maximum elongation were calculated. The experimental data have been used to identify the parameters in specific strain-energy functions given in seven constitutive models of hyperelastic materials: neo-Hookean, Mooney-Rivlin, Ogden, Yeoh, Martins, Humphrey and Veronda-Westmann. An analysis of errors in fitting of theoretical and experimental data was done. Comparison of load -displacement curves for the back and abdomen regions of skin taken showed a different scope of both the mean maximum loading forces and the mean maximum elongation. Samples which have been prepared from the abdominal area had lower values of the mean maximum load compared to samples from the spine area. The reverse trend was observed during the analysis of the values of elongation. An analysis of the accuracy of model fitting to the experimental data showed that, the least accurate were the model of neo- -Hookean, model of Mooney-Rivlin for the abdominal region and model of Veronda-Westmann for the spine region. An analysis of seven hyperelastic material models showed good correlations between the experimental and the theoretical data for five models.

  5. Development of an in vitro skin sensitization test based on ROS production in THP-1 cells.

    PubMed

    Saito, Kazutoshi; Miyazawa, Masaaki; Nukada, Yuko; Sakaguchi, Hitoshi; Nishiyama, Naohiro

    2013-03-01

    Recently, it has been reported that reactive oxygen species (ROS) produced by contact allergens can affect dendritic cell migration and contact hypersensitivity. The aim of the present study was to develop a new in vitro assay that could predict the skin sensitizing potential of chemicals by measuring ROS production in THP-1 (human monocytic leukemia cell line) cells. THP-1 cells were pre-loaded with a ROS sensitive fluorescent dye, 5-(and 6-)-chloromethyl-2', 7'-dichlorodihydrofluorescein diacetate, acetyl ester (CM-H2DCFDA), for 15min, then incubated with test chemicals for 30min. The fluorescence intensity was measured by flow cytometry. For the skin sensitizers, 25 out of 30 induced over a 2-fold ROS production at more than 90% of cell viability. In contrast, increases were only seen in 4 out of 20 non-sensitizers. The overall accuracy for the local lymph node assay (LLNA) was 82% for 50 chemicals tested. A correlation was found between the estimated concentration showing 2-fold ROS production in the ROS assay and the EC3 values (estimated concentration required to induce positive response) of the LLNA. These results indicated that the THP-1 cell-based ROS assay was a rapid and highly sensitive detection system able to predict skin sensitizing potentials and potency of chemicals. Copyright © 2012 Elsevier Ltd. All rights reserved.

  6. A demonstration of lack of variability among six tuberculin skin test readers.

    PubMed Central

    Perez-Stable, E J; Slutkin, G

    1985-01-01

    The variability of tuberculin skin test readings among six trained and experienced readers was evaluated using a modified sliding caliper method. Each of 537 tests were read independently by two readers. There were 23 disagreements between paired readers resulting in an overall interobserver reliability of 95.7 per cent. In 82 per cent of the paired readings the results were different by 2 mm or less. The observer lack of variability was likely due to the training and experience of the readers. PMID:4051078

  7. Effect of Topical Steroids on Skin Prick Test: A Randomized Controlled Trial.

    PubMed

    Ebbesen, Anne R; Riis, Lene A; Gradman, Josefine

    2018-05-04

    Topically applied corticosteroids on the skin can significantly inhibit the wheal response to allergens in skin prick test (SPT). The duration of this effect is unknown. The aim of this study is to investigate the duration of the inhibitory effect of topical corticosteroids on SPT. Twenty-two healthy subjects were included in a single-blinded randomized study. All subjects were skin prick tested using a standard inhalant allergen panel. The subjects were randomized to treat either the left or right forearm with Betnovat ® cream (group III steroid) once a day for 10 days. Subsequently, the subjects were skin prick tested the following 5 days and at day 8 on both forearms. At baseline, the 22 individuals had positive SPT for a total of 72 allergens. Compared with the untreated arm, the mean size of the wheals was significantly reduced on day 1 (12 h after end of treatment) by 0.56 mm (95 % confidence interval (CI) [0.06; 1.06], p = 0.03) for allergens and 0.70 mm [0.32; 1.09] (p = 0.001) for histamine. On day 2 (36 h after end of treatment), the mean difference between treated and untreated arm was 0.47 mm [-0.08; 0.85] (p = 0.02) for allergen-induced wheals and 0.22 mm [-0.21; 0.64] (p = 0.31) for histamine-induced wheal. On day 3, 4, 5, and 8, there was no significant difference. Treatment with topical steroid significantly inhibited the response to SPT for 36 h but for less than 3 days. In addition, we demonstrated that topical applied corticosteroids inhibit the mean wheal size of the positive histamine control for a shorter time than for the allergens. Consequently, positive response to histamine control is not a valid marker for reliable skin prick test in steroid-treated patients. Plain language summary available for this article.

  8. Diagnosing environmental allergies: Comparison of skin-prick, intradermal, and serum specific immunoglobulin E testing

    PubMed Central

    Shtessel, Maria; Lobell, Elizabeth; Hudes, Golda; Rosenstreich, David; de Vos, Gabriele

    2017-01-01

    Background: Allergists commonly perform intradermal skin testing (IDST) after negative skin-prick testing (SPT) to comprehensively diagnose environmental allergic sensitization. However, with the availability of modern methods to detect serum-specific immunoglobulin E (ssIgE), it is unclear if ssIgE testing could substitute for IDST. Objective: To determine the efficacy of ssIgE testing and IDST when added to SPT in diagnosing environmental allergic sensitizations. Methods: SPT, IDST, and ssIgE testing to nine common environmental allergens were analyzed in 75 patients with oculonasal symptoms who presented to our allergy clinics in the Bronx, New York, between January 2014 and May 2015. Results: A total of 651 SPT and 499 ssIgE tests were independently performed and revealed 162 (25%) and 127 (25%) sensitizations, respectively. When SPT results were negative, IDST results revealed 108 of 452 additional sensitizations (24%). In contrast, when SPT results were negative, ssIgE test results only revealed 9% additional sensitizations. When both SPT and IDST results were negative, ssIgE testing only detected 3% of additional sensitizations, and ssIgE levels were typically low in these cases (median, 1.25 kU/L; range, 0.357–4.47 kU/L). When both SPT and ssIgE test results were negative, IDST results detected 15% additional sensitizations. Conclusion: IDST detected more additional environmental sensitizations compared with ssIgE testing. IDST, therefore, may be useful when the SPT and/or ssIgE testing results were negative, but the exposure history indicated relevant allergic sensitization. Serology added only a little more information if both SPT and IDST results were negative but may be useful in combination with SPT if IDST cannot be performed. PMID:28583228

  9. Diagnosing environmental allergies: Comparison of skin-prick, intradermal, and serum specific immunoglobulin E testing.

    PubMed

    Ferastraoaru, Denisa; Shtessel, Maria; Lobell, Elizabeth; Hudes, Golda; Rosenstreich, David; de Vos, Gabriele

    2017-06-01

    Allergists commonly perform intradermal skin testing (IDST) after negative skin-prick testing (SPT) to comprehensively diagnose environmental allergic sensitization. However, with the availability of modern methods to detect serum-specific immunoglobulin E (ssIgE), it is unclear if ssIgE testing could substitute for IDST. To determine the efficacy of ssIgE testing and IDST when added to SPT in diagnosing environmental allergic sensitizations. SPT, IDST, and ssIgE testing to nine common environmental allergens were analyzed in 75 patients with oculonasal symptoms who presented to our allergy clinics in the Bronx, New York, between January 2014 and May 2015. A total of 651 SPT and 499 ssIgE tests were independently performed and revealed 162 (25%) and 127 (25%) sensitizations, respectively. When SPT results were negative, IDST results revealed 108 of 452 additional sensitizations (24%). In contrast, when SPT results were negative, ssIgE test results only revealed 9% additional sensitizations. When both SPT and IDST results were negative, ssIgE testing only detected 3% of additional sensitizations, and ssIgE levels were typically low in these cases (median, 1.25 kU/L; range, 0.357-4.47 kU/L). When both SPT and ssIgE test results were negative, IDST results detected 15% additional sensitizations. IDST detected more additional environmental sensitizations compared with ssIgE testing. IDST, therefore, may be useful when the SPT and/or ssIgE testing results were negative, but the exposure history indicated relevant allergic sensitization. Serology added only a little more information if both SPT and IDST results were negative but may be useful in combination with SPT if IDST cannot be performed.

  10. Assessment of a Protein Cocktail-Based Skin Test for Bovine Tuberculosis in a Double-Blind Field Test in Cattle

    PubMed Central

    Xin, Ting; Jia, Hong; Ding, Jiabo; Li, Pingjun; Yang, Hongjun; Hou, Shaohua; Yuan, Weifeng; Guo, Xiaoyu; Wang, Haichun; Liang, Qianqian; Li, Ming

    2013-01-01

    Bovine tuberculosis (bTB) is a worldwide zoonosis caused mainly by Mycobacterium bovis. The traditional diagnostic method used often is the tuberculin skin test, which uses bovine purified protein derivatives (PPD-B). However, it is difficult to maintain uniformity of PPD-B from batch to batch, and it shares common antigens with nonpathogenic environmental mycobacteria. To overcome these problems, M. bovis-specific antigens that showed good T cell stimulation, such as CFP-10, ESAT-6, Rv3615c, etc., have been used in the skin test, but there have been no large-scale clinical studies on these antigens. In this study, two combinations (CFP-10/ESAT-6/TB10.4 protein cocktail and CFP-10/ESAT-6/Rv3872/MPT63 protein cocktail) were developed and used as stimuli in the skin test. Cattle were double-blind tested to assess the efficiency of the protein cocktail-based skin tests. The results showed that the CFP-10/ESAT-6/TB10.4 protein cocktail-based skin test can differentiate TB-infected cattle from Mycobacterium avium-infected ones and that it shows a high degree of agreement with the traditional tuberculin skin test (κ = 0.8536) and gamma interferon (IFN-γ) release assay (κ = 0.8154). Compared to the tuberculin skin test, the relative sensitivity and relative specificity of the CFP-10/ESAT-6/TB10.4-based skin test were 87% and 97%, respectively., The relative sensitivity and relative specificity of the CFP-10/ESAT-6/TB10.4-based skin test were 93% and 92%, respectively, on comparison with the IFN-γ release assay. The correlation between the increases in skin thickness observed after the inoculation of stimuli was high (PPD-B versus CFP-10/ESAT-6/TB10.4, Spearman r of 0.8435). The correlation between the optical density at 450 nm (OD450) obtained after blood stimulation with PPD-B and the increase in skin thickness observed after inoculation of the CFP-10/ESAT-6/TB10.4 protein cocktail was high (Spearman r = 0.7335). Therefore, the CFP-10/ESAT-6/TB10.4-based skin test

  11. Optimizing skin protection with semipermeable gloves.

    PubMed

    Wulfhorst, Britta; Schwanitz, Hans Joachim; Bock, Meike

    2004-12-01

    Occlusion due to gloves is one important cause of glove irritation. Macerated softened skin gives poor protection against microbes and chemical injuries. The introduction of a breathable protective glove material would represent a significant step toward improved prevention of occupational skin disease. Performance levels of semipermeable and occlusive gloves were examined under conditions typical of the hairdressing profession. In two studies, tests comparing breathable semipermeable gloves to single-use gloves made of occlusive materials were conducted. In an initial study, a user survey was carried out in conjunction with bioengineering examinations. Values at baseline and values after gloves were worn were recorded by measuring transepidermal water loss (TEWL), skin humidity (SH), and skin surface hydrogen ion concentration (pH) in 20 healthy volunteers. In a second study, the gloves were tested for penetrability and permeability with three chemical compounds typically used in the hairdressing profession. Bioengineering examination objectively confirmed users' reports of reduced hand perspiration when semipermeable gloves were worn. The TEWL, SH, and skin surface pH values remained largely stable after 20 minutes of wearing semipermeable gloves, in contrast to the reactions observed with gloves of occlusive materials. Permeability tests indicated that the semipermeable material is effective, with some restrictions. Air leakage testing revealed that all 50 gloves tested were not airtight. Following the optimization of manufacturing methods, additional tests of the penetrability of semipermeable gloves will be necessary.

  12. Primary irritant and delayed-contact hypersensitivity reactions to the freshwater cyanobacterium Cylindrospermopsis raciborskii and its associated toxin cylindrospermopsin

    PubMed Central

    Stewart, Ian; Seawright, Alan A; Schluter, Philip J; Shaw, Glen R

    2006-01-01

    Background Freshwater cyanobacteria are common inhabitants of recreational waterbodies throughout the world; some cyanobacteria can dominate the phytoplankton and form blooms, many of which are toxic. Numerous reports in the literature describe pruritic skin rashes after recreational or occupational exposure to cyanobacteria, but there has been little research conducted on the cutaneous effects of cyanobacteria. Using the mouse ear swelling test (MEST), we sought to determine whether three toxin-producing cyanobacteria isolates and the purified cyanotoxin cylindrospermopsin produced delayed-contact hypersensitivity reactions. Methods Between 8 and 10 female Balb/c mice in each experiment had test material applied to depilated abdominal skin during the induction phase and 10 or 11 control mice had vehicle only applied to abdominal skin. For challenge (day 10) and rechallenge (day 17), test material was applied to a randomly-allocated test ear; vehicle was applied to the other ear as a control. Ear thickness in anaesthetised mice was measured with a micrometer gauge at 24 and 48 hours after challenge and rechallenge. Ear swelling greater than 20% in one or more test mice is considered a positive response. Histopathology examination of ear tissues was conducted by independent examiners. Results Purified cylindrospermopsin (2 of 9 test mice vs. 0 of 5 control mice; p = 0.51) and the cylindrospermopsin-producing cyanobacterium C. raciborskii (8 of 10 test mice vs. 0 of 10 control mice; p = 0.001) were both shown to produce hypersensitivity reactions. Irritant reactions were seen on abdominal skin at induction. Two other toxic cyanobacteria (Microcystis aeruginosa and Anabaena circinalis) did not generate any responses using this model. Histopathology examinations to determine positive and negative reactions in ear tissues showed excellent agreement beyond chance between both examiners (κ = 0.83). Conclusion The irritant properties and cutaneous sensitising potential of

  13. Allergy to cow's milk proteins: what contribution does hypersensitivity in skin tests have to this diagnosis?

    PubMed

    Costa, Aldo José Fernandes; Sarinho, Emanuel Sávio Cavalcanti; Motta, Maria Eugênia Farias Almeida; Gomes, Priscila Nogueira; de Oliveira de Melo, Sabrina Maria; da Silva, Giselia Alves Pontes

    2011-02-01

    Food allergy is an immunologically mediated adverse reaction to food protein. Cow's milk protein allergy (CMPA) is the most frequent type and is the one that is most difficult to diagnose. This study had the objective of analyzing the accuracy of hypersensitivity and specific IgE skin tests among children with CMPA and predominantly gastrointestinal clinical manifestations. The participants in this study were 192 children aged one and five (median of 2 yr). Among these, 122 underwent open oral challenge to the suspected food. After evaluating the sensitivity, specificity and positive and negative predictive values (respectively, PPV and NPV) of skin and specific IgE tests in relation to the gold standard (open oral challenge); all the children underwent the skin prick test (SPT), specific IgE test and atopy patch test (APT) for cow's milk, eggs, wheat and peanuts and the open oral challenge for the food to which the child was sensitive or had suspected sensitivity. Presence of food allergy was confirmed for 50 children (40.9%). Among these cases, 44/50 (88%) were of allergy to cow's milk protein. Children who presented a positive response to an oral challenge to cow's milk protein were considered to be cases, while the controls were children with negative response. Twenty-two of the 44 cases (50.0%) presented symptoms within the first 4 h after the challenge. The SPT presented 31.8% sensitivity, 90.3% specificity, 66.7% PPV and 68.4% NPV. The APT presented 25.0% sensitivity, 81.9% specificity, 45.8% PPV and 64.1% NPV. The specific IgE test presented, respectively, 20.5%, 88.9%, 52.9% and 64.6%. Despite the operational difficulty and the possible exposure risk, oral challenge is the best method for diagnosing CMPA, because of the low sensitivity and PPV of skin and specific IgE tests. © 2011 John Wiley & Sons A/S.

  14. The Results of Autologous Skin Test in Patients with Chronic Urticaria in Hamadan, Iran

    PubMed Central

    Safari, Mojgan; Sayemiri, Hooshyar

    2016-01-01

    Introduction The etiology of chronic urticaria is unknown in many cases. In this study, we demonstrated the presence of autoimmune antibodies in patients with chronic urticaria by using of the Autologous Serum Skin Test (ASST). Methods We performed a cross-sectional study to detect the presence of autologous antibodies in the serum of 38 patients (25 females and 13 males) with idiopathic chronic urticaria who were referred to the Hamedan Allergy Clinic in 2014. All of the necessary tests for demonstrating chronic urticaria were performed, including complete blood count (CBC), thyroid and liver functionality tests, and the prick test but they did not confirm the cause of chronic urticaria. We conducted the Autologous Serum Skin Test on the patients and analyzed the results. Results In 15 patients (39%), the ASST was positive. Of the 15 patients with positive autoimmune chronic urticaria, five patients (33%) were males, and 10 patients (67%) were females. Conclusion We concluded that many patients with chronic urticaria have autoimmune urticaria. It is the reason for the lack of the response to treatment with common medications for urticaria. New ways of treatment must be considered for them. PMID:27504169

  15. Antibiotic-induced immediate type hypersensitivity is a risk factor for positive allergy skin tests for neuromuscular blocking agents.

    PubMed

    Hagau, Natalia; Gherman, Nadia; Cocis, Mihaela; Petrisor, Cristina

    2016-01-01

    Skin tests for neuromuscular blocking agents (NMBAs) are not currently recommended for the general population undergoing general anaesthesia. In a previous study we have reported a high incidence of positive allergy tests for NMBAs in patients with a positive history of non-anaesthetic drug allergy, a larger prospective study being needed to confirm those preliminary results. The objective of this study was to compare the skin tests results for patients with a positive history of antibiotic-induced immediate type hypersensitivity reactions to those of controls without drug allergies. Ninety eight patients with previous antibiotic hypersensitivity and 72 controls were prospectively included. Skin tests were performed for atracurium, pancuronium, rocuronium, and suxamethonium. We found 65 positive skin tests from the 392 tests performed in patients with a positive history of antibiotic hypersensitivity (1 6.58%) and 23 positive skin tests from the 288 performed in controls (7.98%), the two incidences showing significant statistical difference (p = 0.0011). The relative risk for having a positive skin test for NMBAs for patients versus controls was 1.77 (1.15-2.76). For atracurium, skin tests were more often positive in patients with a positive history of antibiotic hypersensitivity versus controls (p = 0.02). For pancuronium, rocuronium and suxamethonium the statistical difference was not attained (p-values 0.08 for pancuronium, 0.23 for rocuronium, and 0.26 for suxamethonium). Patients with a positive history of antibiotic hypersensitivity seem to have a higher incidence of positive skin tests for NMBAs. They might represent a group at higher risk for developing intraoperative anaphylaxis compared to the general population. Copyright © 2015 The Authors. Production and hosting by Elsevier B.V. All rights reserved.

  16. Validation of the cephalosporin intradermal skin test for predicting immediate hypersensitivity: a prospective study with drug challenge.

    PubMed

    Yoon, S-Y; Park, S Y; Kim, S; Lee, T; Lee, Y S; Kwon, H-S; Cho, Y S; Moon, H-B; Kim, T-B

    2013-07-01

    Cephalosporin is a major offending agent in terms of drug hypersensitivity along with penicillin. Cephalosporin intradermal skin tests (IDTs) have been widely used; however, their validity for predicting immediate hypersensitivity has not been studied. This study aimed to determine the predictive value of cephalosporin intradermal skin testing before administration of the drug. We prospectively conducted IDTs with four cephalosporins, one each of selected first-, second-, third-, or fourth-generation cephalosporins: ceftezol; cefotetan or cefamandole; ceftriaxone or cefotaxime; and flomoxef, respectively, as well as with penicillin G. After the skin test, whatever the result, one of the tested cephalosporins was administered intravenously and the patient was carefully observed. We recruited 1421 patients who required preoperative cephalosporins. Seventy-four patients (74/1421, 5.2%) were positive to at least one cephalosporin. However, none of responders had immediate hypersensitivity reactions after a challenge dose of the same or different cephalosporin, which were positive in the skin test. Four patients who suffered generalized urticaria and itching after challenge gave negative skin tests for the corresponding drug. The IDT for cephalosporin had a sensitivity of 0%, a specificity of 97.5%, a negative predictive value of 99.7%, and a positive predictive value (PPV) of 0%, when challenged with the same drugs that were positive in the skin test. Routine skin testing with a cephalosporin before its administration is not useful for predicting immediate hypersensitivity because of the extremely low sensitivity and PPV of the skin test (CRIS registration no. KCT0000455). © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. Water immersion decreases sympathetic skin response during color–word Stroop test

    PubMed Central

    Yamazaki, Yudai; Takahashi, Akari; Uetake, Yoshihito; Nakano, Saki; Iguchi, Kaho; Baba, Yasuhiro; Nara, Rio; Shimoyama, Yoshimitsu

    2017-01-01

    Water immersion alters the autonomic nervous system (ANS) response in humans. The effect of water immersion on executive function and ANS responses related to executive function tasks was unknown. Therefore, this study aimed to determine whether water immersion alters ANS response during executive tasks. Fourteen healthy participants performed color–word-matching Stroop tasks before and after non-immersion and water immersion intervention for 15 min in separate sessions. The Stroop task-related skin conductance response (SCR) was measured during every task. In addition, the skin conductance level (SCL) and electrocardiograph signals were measured over the course of the experimental procedure. The main findings of the present study were as follows: 1) water immersion decreased the executive task-related sympathetic nervous response, but did not affect executive function as evaluated by Stroop tasks, and 2) decreased SCL induced by water immersion was maintained for at least 15 min after water immersion. In conclusion, the present results suggest that water immersion decreases the sympathetic skin response during the color–word Stroop test without altering executive performance. PMID:28742137

  18. Water immersion decreases sympathetic skin response during color-word Stroop test.

    PubMed

    Sato, Daisuke; Yamazaki, Yudai; Takahashi, Akari; Uetake, Yoshihito; Nakano, Saki; Iguchi, Kaho; Baba, Yasuhiro; Nara, Rio; Shimoyama, Yoshimitsu

    2017-01-01

    Water immersion alters the autonomic nervous system (ANS) response in humans. The effect of water immersion on executive function and ANS responses related to executive function tasks was unknown. Therefore, this study aimed to determine whether water immersion alters ANS response during executive tasks. Fourteen healthy participants performed color-word-matching Stroop tasks before and after non-immersion and water immersion intervention for 15 min in separate sessions. The Stroop task-related skin conductance response (SCR) was measured during every task. In addition, the skin conductance level (SCL) and electrocardiograph signals were measured over the course of the experimental procedure. The main findings of the present study were as follows: 1) water immersion decreased the executive task-related sympathetic nervous response, but did not affect executive function as evaluated by Stroop tasks, and 2) decreased SCL induced by water immersion was maintained for at least 15 min after water immersion. In conclusion, the present results suggest that water immersion decreases the sympathetic skin response during the color-word Stroop test without altering executive performance.

  19. The sensitization potential of sunscreen after ablative fractional skin resurfacing using modified human repeated insult patch test.

    PubMed

    Boonchai, Waranya; Sathaworawong, Angkana; Wongpraparut, Chanisada; Wanitphakdeedecha, Rungsima

    2015-10-01

    Ablative fractional skin resurfacing has become popular and proven to be useful in treating scars, photoaging and wrinkles. Although post-inflammatory hyperpigmentation (PIH) is the most common complication especially in dark-skinned patients like Asian. Several modalities have been used to overcome the PIH. To determine the sensitization potential of sunscreen applied immediately after ablative fractional skin resurfacing. Sixty volunteers were recruited. Of these 30 subjects were from previous ablative fractional skin resurfacing study who applied broad-spectrum sunscreen containing anti-inflammatory agent starting on the first day after resurfacing and another 30 non-resurfacing subjects had applied the same sunscreen on the intact skin. All subjects were patch/photopatch tested for sensitization study by using modified human repeated insult patch test (HRIPT). There were significantly higher sensitization rate of UV-filter, octocrylene and the sunscreen in resurfacing group than in non-resurfacing group. Early application of sunscreen after ablative fractional skin resurfacing has increased the incidence of sensitization potential of sunscreen. The sunscreen is recommended to start using from D3 after fractional ablative skin resurfacing to ensure the complete recovery of skin barrier and minimize the risk of sensitization.

  20. Detectability of bovine TB using the tuberculin skin test does not vary significantly according to pathogen genotype within Northern Ireland.

    PubMed

    Wright, David M; Allen, Adrian R; Mallon, Thomas R; McDowell, Stanley W J; Bishop, Stephen C; Glass, Elizabeth J; Bermingham, Mairead L; Woolliams, John A; Skuce, Robin A

    2013-10-01

    Strains of many infectious diseases differ in parameters that influence epidemic spread, for example virulence, transmissibility, detectability and host specificity. Knowledge of inter-strain variation can be exploited to improve management and decrease disease incidence. Bovine tuberculosis (bTB) is increasingly prevalent among farmed cattle in the UK, exerting a heavy economic burden on the farming industry and government. We aimed to determine whether strains of Mycobacterium bovis (the causative agent of bTB) identified and classified using genetic markers (spoligotyping and multi-locus VNTR analysis) varied in response to the tuberculin skin test; this being the primary method of bTB detection used in the UK. Inter-strain variation in detectability of M. bovis could have important implications for disease control. The skin test is based on a differential delayed type hypersensitivity (DTH) response to intradermal injections of purified protein derivative (PPD) from M. bovis (PPD-B) and Mycobacterium avium (PPD-A). We searched for an association between skin test response (PPD-B skin rise minus PPD-A skin rise) and M. bovis genotype at the disclosing test in culture-confirmed cases using a field dataset consisting of 21,000 isolates belonging to 63 genotypes of M. bovis from cattle in Northern Ireland. We found no substantial variation among genotypes (estimated responses clustered tightly around the mean) controlling for animal sex, breed and test effects. We also estimated the ratio of skin test detected to undetected cases (i.e. cases only detected at abattoir). The skin test detection ratio varied among abattoirs with some detecting a greater proportion of cases than others but this variation was unrelated to the community composition of genotypes within each abattoir catchment. These two lines of evidence indicate that M. bovis genotypes in Northern Ireland have similar detectability using the skin test. Crown Copyright © 2013. Published by Elsevier B

  1. Decreased ATP synthesis and lower pH may lead to abnormal muscle contraction and skin sensitivity in human skin.

    PubMed

    Kim, Eun Ju; Lee, Dong Hun; Kim, Yeon Kyung; Kim, Min-Kyoung; Kim, Jung Yun; Lee, Min Jung; Choi, Won Woo; Eun, Hee Chul; Chung, Jin Ho

    2014-12-01

    Sensitive skin represents hyperactive sensory symptoms showing exaggerated reactions in response to internal stimulants or external irritants. Although sensitive skin is a very common condition affecting an estimated 50% of the population, its pathophysiology remains largely elusive, particularly with regard to its metabolic aspects. The objective of our study was to investigate the pathogenesis of sensitive skin. We recruited healthy participants with 'sensitive' or 'non-sensitive' skin based on standardized questionnaires and 10% lactic acid stinging test, and obtained skin samples for microarray analysis and subsequent experiments. Microarray transcriptome profiling revealed that genes involved in muscle contraction, carbohydrate and lipid metabolism, and ion transport and balance were significantly decreased in sensitive skin. These altered genes could account for the abnormal muscle contraction, decreased ATP amount in sensitive skin. In addition, pain-related transcripts such as TRPV1, ASIC3 and CGRP were significantly up-regulated in sensitive skin, compared with non-sensitive skin. Our findings suggest that sensitive skin is closely associated with the dysfunction of muscle contraction and metabolic homeostasis. Copyright © 2014 Japanese Society for Investigative Dermatology. Published by Elsevier Ireland Ltd. All rights reserved.

  2. Opisthorchis felineus negatively associates with skin test reactivity in Russia-EuroPrevall-International Cooperation study.

    PubMed

    Fedorova, O S; Janse, J J; Ogorodova, L M; Fedotova, M M; Achterberg, R A; Verweij, J J; Fernández-Rivas, M; Versteeg, S A; Potts, J; Minelli, C; van Ree, R; Burney, P; Yazdanbakhsh, M

    2017-07-01

    Most studies on the relationship between helminth infections and atopic disorders have been conducted in (sub)tropical developing countries where exposure to multiple parasites and lifestyle can confound the relationship. We aimed to study the relationship between infection with the fish-borne helminth Opishorchis felineus and specific IgE, skin prick testing, and atopic symptoms in Western Siberia, with lifestyle and hygiene standards of a developed country. Schoolchildren aged 7-11 years were sampled from one urban and two rural regions. Skin prick tests (SPT) and specific IgE (sIgE) against food and aeroallergens were measured, and data on allergic symptoms and on demographic and socioeconomic factors were collected by questionnaire. Diagnosis of opisthorchiasis was based on PCR performed on stool samples. Of the 732 children included, 34.9% had opisthorchiasis. The sensitization to any allergen when estimated by positive SPT was 12.8%, while much higher, 24.0%, when measured by sIgE. Atopic symptoms in the past year (flexural eczema and/or rhinoconjunctivitis) were reported in 12.4% of the children. SPT was positively related to flexural eczema and rhinoconjunctivitis, but not to wheezing. Opisthorchiasis showed association with lower SPT response, as well as borderline association with low IgE reactivity to any allergen. However, the effect of opisthorchiasis on SPT response was not mediated by IgE, suggesting that opisthorchiasis influences SPT response through another mechanism. Opisthorchiasis also showed borderline association with lower atopic symptoms. There is a negative association between a chronic helminth infection and skin prick test reactivity even in a developed country. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  3. Skin prick/puncture testing in North America: a call for standards and consistency.

    PubMed

    Fatteh, Shahnaz; Rekkerth, Donna J; Hadley, James A

    2014-01-01

    Skin prick/puncture testing (SPT) is widely accepted as a safe, dependable, convenient, and cost-effective procedure to detect allergen-specific IgE sensitivity. It is, however, prone to influence by a variety of factors that may significantly alter test outcomes, affect the accuracy of diagnosis, and the effectiveness of subsequent immunotherapy regimens. Proficiency in SPT administration is a key variable that can be routinely measured and documented to improve the predictive value of allergy skin testing. Literature surveys were conducted to determine the adherence to repeated calls for development and implementation of proficiency testing standards in the 1990's, the mid-2000's and the 2008 allergy diagnostics practice parameters. Authors publishing clinical research in peer-reviewed journals and conducting workshops at annual scientific meetings have recommended proficiency testing based primarily on its potential to reduce variability, minimize confounding test results, and promote more effective immunotherapeutic treatments. Very few publications of clinical studies, however, appear to report proficiency testing data for SPT performance. Allergen immunotherapy recommendations are updated periodically by the Joint Task Force on Practice Parameters representing the American Academy of Allergy, Asthma and Immunology (AAAAI), the American College of Allergy, Asthma and Immunology (ACAAI), and the Joint Council of Allergy, Asthma and Immunology (JCAAI). Despite consensus that all staff who perform SPT should meet basic quality assurance standards that demonstrate their SPT proficiency, the gap between recommendations and daily practice persists. By embracing standards, the accuracy of SPT and allergy diagnosis can be optimized, ultimately benefiting patients with allergic disease.

  4. Skin prick testing in atopic eczema: atopic to what and at what age?

    PubMed

    Hon, Kam Lun; Wang, Shuxin Susan; Wong, Wing Lam; Poon, Wing Kwan; Mak, Ka Yi; Leung, Ting Fan

    2012-05-01

    Atopic eczema is a common and distressing disease. This study aimed to review the age-dependent pattern of atopic sensitization to food and aeroallergens in patients with eczema by skin prick testing. The results of skin prick test (SPT), serum IgE, bronchial challenge test, and family history of atopy in eczema patients seen at a pediatric dermatology clinic were reviewed. SPT results were available in 816 eczema patients. In these patients, 90% had atopic sensitization to at least one aeroallergen, 69% to at least one food allergen, and 94% to at least one allergen by SPT. Together with a family history of atopy in parents or siblings and a personal history of airway atopies, 97% and 99.8% of the patients were atopic, respectively. Bronchial hyper-reactivity (BHR) was demonstrated in 44% of 339 patients. Aeroallergen was more prevalent than food allergen sensitization among children older than 10 years. The mites (D. pteronysissnus, D. farinae and Blomia Tropicalis) were the most prevalent allergens regardless of age and BHR, but D. pteronysissnus and D. farinae sensitization were more prevalent among BHR-positive patients. Beef is the least sensitized food protein in all ages. The majority of patients with eczema are atopic to aeroallergens. The mites (D. pteronysissnus, D. farinae and Blomia Tropicalis) are the most prevalent allergens regardless of age and BHR.

  5. Generalized reactions during skin testing with clindamycin in drug hypersensitivity: a report of 3 cases and review of the literature.

    PubMed

    Papakonstantinou, Eleni; Müller, Sabine; Röhrbein, Jan H; Wieczorek, Dorothea; Kapp, Alexander; Jakob, Thilo; Wedi, Bettina

    2018-04-01

    The diagnostic approach to drug hypersensitivity includes a detailed medical history, clinical examination, and skin testing and/or oral challenge with a culprit or alternative drug, depending on the type of reaction and the suspected drugs. Although skin testing is considered to be rather safe, cutaneous and systemic, including fatal, reactions have been described. To report 3 cases with generalized delayed reactions after skin testing with clindamycin, and to review the existing literature. Thorough clinical examination, blood tests and prick, intradermal and patch tests were performed in 3 patients. All patients experienced generalized maculopapular exanthema after intradermal and patch testing with clindamycin and amoxicillin in the first patient, and clindamycin alone in the second and third patient. None of the patients showed immediate reactions to skin tests, while positive intradermal reactions after 24 h to amoxicillin and clindamycin were observed in the first patient, and positive intradermal reactions after 24 h to clindamycin were observed in the second and third patients. Skin testing with clindamycin in the diagnosis of drug hypersensitivity carries some risk of adverse reactions. A stepwise and individual diagnostic work-up, considering potential risk factors, and testing in a specialized centre with emergency equipment available is highly recommended. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  6. A new, female-specific irritability rating scale

    PubMed Central

    Born, Leslie; Koren, Gideon; Lin, Elizabeth; Steiner, Meir

    2008-01-01

    Objective Irritability is a prominent symptom in the spectrum of female-specific mood disorders, and in some women, irritability is serious enough to disrupt their lives and warrant treatment. The objective of this research was to develop a new, female-specific state measure of irritability. Methods We constructed self-rating and observer rating scales using items derived from spontaneous descriptions of irritability by women with mood disturbances related to the menstrual cycle, childbearing or menopause. Following a pretest, the scales were shortened to the core items of irritability (annoyance, anger, tension, hostility, sensitivity to noise and touch) and tested on a new cohort of patients. Results The 14-item Self-Rating Scale and the 5-item Observer Rating Scale showed evidence for internal consistency (Self-Rating: n = 36 patients, Cronbach's α = 0.9257, mean interitem correlation = 0.4690; Observer Rating: Cronbach's α = 0.7418, mean interitem correlation = 0.3616), Self-Rating test–retest reliability (n = 29 patients, rs = 0.704, p = 0.01) and interrater reliability (n = 20 patients; τb = 1.000, p = 0.001). Conclusion This new, female-specific scale for rating irritability has the potential to further the evaluation of this prominent symptom cluster and increase specificity in clinical assessments of emotional disturbances related to reproductive cyclicity in women. PMID:18592028

  7. Variability of Offending Allergens of Allergic Rhinitis According to Age: Optimization of Skin Prick Test Allergens

    PubMed Central

    Lee, Ji-Eun; Ahn, Jae-Chul; Han, Doo Hee; Kim, Dong-Young; Kim, Jung-Whun; Cho, Sang-Heon; Park, Heung-Woo

    2014-01-01

    Purpose This study evaluates offending allergens in patients with allergic rhinitis (AR) according to age that establish a minimal panel for skin prick test (SPT) allergens required to identify if a patient is sensitized. Methods We retrospectively analyzed SPT results according to age to determine the minimum test battery panel necessary to screen at least 93%-95% of AR patients. Allergic skin tests (common airborne indoor and outdoor allergens) were performed on 7,182 patients from January 2007 to June 2011. All patients were classified into 9 groups according to age; subsequently, we investigated offending allergens by age group. Results A total of 5,032 (70.1%) patients were found sensitized to at least one of the 55 aeroallergen extracts tested. The annual ranking of offending allergens was not significantly different from each other over the past 5 years. House dust mites (HDM) were the most prevalent allergens ranked from first to third for all 5 years. The allergens in the minimum test panel differed slightly among all age groups; in addition, the types of sensitized allergen sources were more diverse in the older versus younger age group. HDM covered a larger proportion of the sensitized allergens in the younger age group versus the older age group. Testing with 5 allergens (Dermatophagoides farinae, Tetranychus urticae, oak, mugwort and cockroach) adequately identified over 90% of the sensitized patients. Conclusions A SPT with around 5-7 allergens adequately detected most of the sensitization in the majority of the age groups in Korea. However, this study suggests that physicians perform the SPT with appropriately selected allergens in each age category for the screening of AR. PMID:24404393

  8. Variability of offending allergens of allergic rhinitis according to age: optimization of skin prick test allergens.

    PubMed

    Lee, Ji-Eun; Ahn, Jae-Chul; Han, Doo Hee; Kim, Dong-Young; Kim, Jung-Whun; Cho, Sang-Heon; Park, Heung-Woo; Rhee, Chae-Seo

    2014-01-01

    This study evaluates offending allergens in patients with allergic rhinitis (AR) according to age that establish a minimal panel for skin prick test (SPT) allergens required to identify if a patient is sensitized. We retrospectively analyzed SPT results according to age to determine the minimum test battery panel necessary to screen at least 93%-95% of AR patients. Allergic skin tests (common airborne indoor and outdoor allergens) were performed on 7,182 patients from January 2007 to June 2011. All patients were classified into 9 groups according to age; subsequently, we investigated offending allergens by age group. A total of 5,032 (70.1%) patients were found sensitized to at least one of the 55 aeroallergen extracts tested. The annual ranking of offending allergens was not significantly different from each other over the past 5 years. House dust mites (HDM) were the most prevalent allergens ranked from first to third for all 5 years. The allergens in the minimum test panel differed slightly among all age groups; in addition, the types of sensitized allergen sources were more diverse in the older versus younger age group. HDM covered a larger proportion of the sensitized allergens in the younger age group versus the older age group. Testing with 5 allergens (Dermatophagoides farinae, Tetranychus urticae, oak, mugwort and cockroach) adequately identified over 90% of the sensitized patients. A SPT with around 5-7 allergens adequately detected most of the sensitization in the majority of the age groups in Korea. However, this study suggests that physicians perform the SPT with appropriately selected allergens in each age category for the screening of AR.

  9. In vitro and in vivo characterization of hazelnut skin prick test extracts.

    PubMed

    Akkerdaas, Jaap H; Wensing, Marjolein; Knulst, André C; Aalberse, Rob C; Hefle, Susan L; van Ree, Ronald

    2003-01-01

    Hazelnut allergy ranks among the most frequently observed food allergies. Clinical symptoms range from the oral allergy syndrome to life threatening anaphylaxis. Diagnosis of hazelnut allergy partially relies on in vivo testing by means of skin prick testing (SPT). The aim of this study was to characterize hazelnut SPT extracts both in vitro and in vivo. Hazelnut SPT extracts were investigated for protein concentration and composition. The major hazelnut allergen Cor a 1, lipid transfer protein (LTP) and thaumatin-like-protein (TLP) were monitored by competitive RIA and immunoblotting. SPT extracts (n = 6) were analyzed for skin reactivity and the correlation between the SPT extract protein concentration and the mean skin reactivity (HEIC) was determined in a group of hazelnut-allergic patients (n = 30). For one SPT extract, the threshold level for Cor a 1 was determined in Cor a 1-monosensitized patients (n = 5). Protein concentrations ranged from 0.2-14 mg/ml. Although some proteins were present in most extracts (bands at 10, 22-28, 32 and around 48 kDa), clear differences in composition were observed (both intra- and inter-variability). The concentration of the major hazelnut allergen Cor a 1 differed up to a factor 50 (0.6-32 micrograms/ml). LTP was virtually absent in 3/9 SPT extracts and variable quantities of TLP were detected by immunoblotting. Some patients (6/30) had a false-negative SPT with 3/6 SPT extracts. There was a clear correlation between the protein concentration and the mean HEIC (RPearson = 0.87). The threshold level for Cor a 1 was +/- 3.2 ng/ml as assessed with one of the products investigated. Heterogeneous protein concentration/composition of SPT extracts results in variable skin test responses. The absence of potentially severe allergens like LTP may lead to false-negative SPT results that jeopardize a patient's safety. From these results it can be concluded that there is a strong need for standardization of products for SPT.

  10. The longest wheal diameter is the optimal measurement for the evaluation of skin prick tests.

    PubMed

    Konstantinou, George N; Bousquet, Philippe-Jean; Zuberbier, Torsten; Papadopoulos, Nikolaos G

    2010-01-01

    Mean diameter or longest diameter are the 2 most frequently used parameters for wheal response assessment after skin prick testing (SPT). We aimed to compare these 2 parameters taking as gold standard the surface of the wheal skin response. Patients suspected of having an allergic reaction against inhalant allergens have been skin prick tested using the Pan-European GA(2)LEN SPT panel. Fifteen minutes later, macroscopically evident wheal and flare reactions were marked with a pen and transferred to paper with a transparent scotch tape. Each paper-transferred wheal was scanned with an ordinary scanner, and its surface-corresponding maximum perpendicular diameters and longest diameters were measured using a computer software application for image recognition, developed for this purpose. Correlation coefficients (Spearman's rho) between surfaces and respective mean (rho(mean)) or longest (rho(longest)) diameters were calculated and subsequently compared. 1,554 SPTs were performed in 74 patients. In 264, a macroscopically evident wheal and flare response was observed. Both mean and longest diameters correlated significantly with the wheal surfaces. However, rho(longest) was statistically significantly larger than rho(mean) when the surface of the wheal was >17 mm(2) (rho(longest) > 0.860 vs. rho(mean) < 0.660; p < 0.05).Such a surface corresponds to a maximum diameter of approximately 7 mm and a mean diameter of approximately 6 mm. Thus, the larger the surface of the wheal, the more appropriate the usage of the longest diameter. The longest wheal diameter alone seems to be a better surrogate marker of the wheal surface in comparison with the mean diameter. In addition, it is easier and faster to measure. Therefore, we propose this as the optimal methodology to evaluate SPTs. 2009 S. Karger AG, Basel.

  11. Association between parasitic infections and tuberculin skin test results in refugees.

    PubMed

    Watts, Nathaniel S; Mizinduko, Mucho M; Barnett, Elizabeth D; White, Laura F; Hochberg, Natasha S

    Parasitic infections are known to modulate the immune response necessary for controlling Mycobacterium tuberculosis infection. We sought to investigate species-specific effects of parasite infection on M. tuberculosis infection. As part of the Refugee Health Assessment Program, stool examinations and tuberculin skin testing were performed on refugees seen at Boston Medical Center between 1995 and 2012. Tuberculin skin test (TST) and stool examination data were collected for 6669 refugees; 3349 (50.2%) were TST positive (≥10 mm). Among TST-positive subjects, 176 (5.3%) had helminth infections and 1149 (34.3%) protozoa. After adjusting for sex, age, and country of origin, helminth and protozoan infections were not associated with TST-positivity. When species-specific effects were examined, subjects infected with Trichuris trichiura and Giardia lamblia had reduced odds of TST-positivity (adjusted OR [aOR] 0.65 [95%CI 0.44-0.96; p = 0.03] and aOR 0.79 [95%CI 0.65-0.95, p = 0.01], respectively). Our findings suggest that T. trichiura and G. lamblia may provide protection against M. tuberculosis infection. This study adds to a growing body of literature suggesting that immune response modulation and susceptibility to M. tuberculosis infection is parasite species-dependent. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Parental smoking and allergic sensitization in offspring defined by skin prick testing.

    PubMed

    Larsson, Matz L; Magnuson, Anders; Montgomery, Scott M

    2005-08-01

    Investigations of parental smoking during childhood and allergic sensitization have produced contradictory results, but this may be because of variations in the definition of allergy and other influences. We investigated associations of parental smoking with an objective measure of allergy, skin prick testing (SPT), and considered associations with maternal and paternal smoking, independently of each other. A stratified random sample, aged 22-74 yr, of 720 Swedish FinEsS-study members were skin prick tested for 15 allergens. Subjects with at least one positive SPT were defined as atopic. Data on childhood exposures, including parental smoking, were collected by structured interview. Logistic regression used atopy as the dependent variable. After adjustment, paternal smoking was statistically significantly associated with an increased risk and maternal smoking a non-statistically significant decreased risk in offspring, with odds ratios (and 95% confidence intervals) of 1.48 (1.04-2.10) and 0.73 (0.48-1.12), respectively. Analysis of families with a non-smoking mother produced an odds ratio for paternal smoking of 1.61 (1.09-2.37). The negative association between maternal smoking and atopy may not operate through passive smoke exposure and could conceal a significant increased risk associated with passive exposure to tobacco smoke in childhood.

  13. EAACI position paper: skin prick testing in the diagnosis of occupational type I allergies.

    PubMed

    van Kampen, V; de Blay, F; Folletti, I; Kobierski, P; Moscato, G; Olivieri, M; Quirce, S; Sastre, J; Walusiak-Skorupa, J; Raulf-Heimsoth, M

    2013-01-01

    Skin prick testing (SPT) in combination with the clinical history of the patient is one important step in the diagnosis of IgE-mediated occupational allergies. However, skin test performance is related to the quality of allergen extracts. The present consensus document was prepared by an EAACI Task Force consisting of an expert panel of allergologists and occupational physicians from Germany, Italy, Spain, France, Austria, and Poland. All members of the panel were also involved in the data collection within the European multicentre study STADOCA (Standard diagnosis for occupational allergy). The aim of this Task Force was the assessment of the quality of commercially available SPT solutions for selected occupational allergens under standardized procedure conditions in different European centres and institutes of Occupational Medicine. The data evaluation shows a wide variability among SPT solutions and also indicates that the sensitivity of several SPT solutions is low. Therefore, improvement and standardization of SPT solutions for occupational allergens is highly recommended. Clinical practitioners should also not presume that their SPT solutions are fully reliable. The main objective of the document is to issue consensus suggestions for the use of SPT with occupational allergens based on the European multicentre study STADOCA, on existing scientific evidence and the expertise of a panel of allergologists. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

  14. Interventions for preventing occupational irritant hand dermatitis.

    PubMed

    Bauer, Andrea; Rönsch, Henriette; Elsner, Peter; Dittmar, Daan; Bennett, Cathy; Schuttelaar, Marie-Louise A; Lukács, Judit; John, Swen Malte; Williams, Hywel C

    2018-04-30

    Occupational irritant hand dermatitis (OIHD) causes significant functional impairment, disruption of work, and discomfort in the working population. Different preventive measures such as protective gloves, barrier creams and moisturisers can be used, but it is not clear how effective these are. This is an update of a Cochrane review which was previously published in 2010. To assess the effects of primary preventive interventions and strategies (physical and behavioural) for preventing OIHD in healthy people (who have no hand dermatitis) who work in occupations where the skin is at risk of damage due to contact with water, detergents, chemicals or other irritants, or from wearing gloves. We updated our searches of the following databases to January 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLlNE, and Embase. We also searched five trials registers and checked the bibliographies of included studies for further references to relevant trials. We handsearched two sets of conference proceedings. We included parallel and cross-over randomised controlled trials (RCTs) which examined the effectiveness of barrier creams, moisturisers, gloves, or educational interventions compared to no intervention for the primary prevention of OIHD under field conditions. We used the standard methodological procedures expected by Cochrane. The primary outcomes were signs and symptoms of OIHD developed during the trials, and the frequency of treatment discontinuation due to adverse effects. We included nine RCTs involving 2888 participants without occupational irritant hand dermatitis (OIHD) at baseline. Six studies, including 1533 participants, investigated the effects of barrier creams, moisturisers, or both. Three studies, including 1355 participants, assessed the effectiveness of skin protection education on the prevention of OIHD. No studies were eligible that investigated the effects of protective gloves. Among each type of intervention, there was heterogeneity concerning

  15. Studies on the cellular and subcellular reactions in epidermis at irritant and allergic dermatitis.

    PubMed

    Lindberg, M

    1982-01-01

    To determine the cellular and subcellular reactions of keratinocytes at contact dermatitis, transmission electron microscopy was used in combination with energy dispersive X-ray microanalysis. Stereology and optical diffraction were used as complements to electron microscopy for studies of the effects of variations in the preparation technique on the ultrastructure of epidermis. The morphological effects of an increased hydration of epidermis were assessed by the use of occlusive patch tests. It was found that the relative volume of the epidermal intercellular space and the ultrastructure of the epidermal cells (keratinocytes and Langerhans' cells) were directly dependent on the osmolality of the fixative vehicle if glutaraldehyde was used as fixative. Cellular volume and morphology did also depend on the fixative used. Variations in the volume of the intercellular space were also detected when the water transport through epidermis was impaired by occlusive treatment. In normal epidermis prolonged fixation times (4 weeks) did not affect the morphology of the keratinocytes. However, if the structure and function of the keratinocytes were affected by the application of a irritant substance (DNCB), a loss of electron dense material from the cells was detected within 3 weeks. The ultrastructural changes in the keratinocytes at the irritant chromate and DNCB reactions were of a non-specific nature and are in accordance with the changes described for other irritant agents in the literature. A few cells with the features of apoptosis were recorded. The allergic chromate reaction was found to be a combination of the irritant reaction and a marked inflammatory response. To correlate the ultrastructural alterations in the keratinocytes with the functional state of the cells, X-ray microanalysis was used to determine the elemental redistribution occurring at the irritant DNCB reaction. The results of the X-ray microanalysis showed a good correlation between dose and time

  16. Intraoperative anaphylaxis to sugammadex and a protocol for intradermal skin testing.

    PubMed

    Sadleir, P H M; Russell, T; Clarke, R C; Maycock, E; Platt, P R

    2014-01-01

    Sugammadex is a selective binding agent for aminosteroid neuromuscular blockers whose use is increasing in anaesthetic practice. We present three cases of severe anaphylaxis coincident with sugammadex administration. Subsequent intradermal testing confirmed sugammadex as the triggering agent, with all patients having positive skin responses to a 1:100 dilution of the standard 100 mg/ml solution and two out of three having a positive response to a 1:1000 dilution. As all patients were administered sugammadex to reverse neuromuscular blockade with rocuronium, we considered that sugammadex-rocuronium complexes were a potential unique allergen. In the two patients who were additionally tested with a rocuronium-sugammadex (3.6:1 molecular ratio) mixture, the wheal-and-flare response was significantly attenuated.

  17. Intradermal skin tests for rocuronium and cisatracurium in patients with a history of allergy: a retrospective study.

    PubMed

    Kim, Yu Yil; Kim, Ik Thae; Shin, Sung In; Yim, So Mang

    2018-04-24

    Neuromuscular blocking agents (NMBAs) are a leading cause of perioperative anaphylaxis. However, the performance of systematic screening skin tests to detect reactions for NMBAs prior to general anesthesia is not recommended. We retrospectively examined intradermal tests (IDTs) for rocuronium and cisatracurium in patients with a history of allergy. We reviewed the records of patients who underwent IDTs for NMBAs between January 1 and December 31, 2016. We analyzed the patients' allergy histories and skin test results for NMBAs. The overall prevalence of positive IDTs was 5.8% (26/451), and there was no significant difference in prevalence among allergy types (P = 0.655). In logistic regression analysis, there was no allergy history that had a significant effect on positive IDT for NMBAs. We found no association between allergy history and positive skin test for NMBAs. Therefore, a systematic screening test for NMBAs or other anesthetic agents before anesthesia is not considered necessary even in patients with an allergy history.

  18. Skin sensitisation: the Colipa strategy for developing and evaluating non-animal test methods for risk assessment.

    PubMed

    Maxwell, Gavin; Aeby, Pierre; Ashikaga, Takao; Bessou-Touya, Sandrine; Diembeck, Walter; Gerberick, Frank; Kern, Petra; Marrec-Fairley, Monique; Ovigne, Jean-Marc; Sakaguchi, Hitoshi; Schroeder, Klaus; Tailhardat, Magali; Teissier, Silvia; Winkler, Petra

    2011-01-01

    Allergic contact dermatitis is a delayed-type hypersensitivity reaction induced by small reactive chemicals (haptens). Currently, the sensitising potential and potency of new chemicals is usually characterised using data generated via animal studies, such as the local lymph node assay (LLNA). There are, however, increasing public and political concerns regarding the use of animals for the testing of new chemicals. Consequently, the development of in vitro, in chemico or in silico models for predicting the sensitising potential and/or potency of new chemicals is receiving widespread interest. The Colipa Skin Tolerance task force currently collaborates with and/or funds several academic research groups to expand our understanding of the molecular and cellular events occurring during the acquisition of skin sensitisation. Knowledge gained from this research is being used to support the development and evaluation of novel alternative approaches for the identification and characterisation of skin sensitizing chemicals. At present three non-animal test methods (Direct Peptide Reactivity Assay (DPRA), Myeloid U937 Skin Sensitisation Test (MUSST) and human Cell Line Activation Test (hCLAT)) have been evaluated in Colipa interlaboratory ring trials for their potential to predict skin sensitisation potential and were recently submitted to ECVAM for formal pre-validation. Data from all three test methods will now be used to support the study and development of testing strategy approaches for skin sensitiser potency prediction. This publication represents the current viewpoint of the cosmetics industry on the feasibility of replacing the need for animal test data for informing skin sensitisation risk assessment decisions.

  19. Skin Test Reactivity to Hymenoptera Venom after Venom Immunotherapy Correlates Inversely with the IgG/IgE Ratio.

    PubMed

    Saulite, Ieva; Hoetzenecker, Wolfram; Guenova, Emmanuella; Schmid-Grendelmeier, Peter; Glatz, Martin

    2017-01-01

    Skin test reactivity to hymenoptera venom and venom-specific IgE are important for diagnosing venom allergy and deciding on the appropriate allergen for venom immunotherapy (VIT). Longitudinal data on skin test reactivity during VIT and their correlation with venom-specific immunoglobulin (Ig)E and IgG are scarce. We retrospectively analyzed shifts in skin test reactivity and serum levels of venom-specific IgE and IgG in patients allergic to hymenoptera venom before the initiation of VIT with ultrarush therapy and after ≥3 years of VIT. Fifty-four patients received ultrarush desensitization and subsequent VIT with wasp venom, 26 with honeybee venom, and 8 with both wasp and honeybee venom. Hymenoptera-specific skin test reactivity decreased during VIT in most patients, and became negative in 8% of the wasp-allergic patients and in 25% of the honeybee-allergic patients. Serum levels of venom-specific IgE positively correlated to skin test reactivity before VIT, but did not change significantly during VIT. IgG serum levels and the IgG/IgE ratio increased during VIT in most patients. A high IgG/IgE ratio correlated with low skin test reactivity after ≥3 years of VIT. The correlation between a high venom-specific IgG/IgE ratio and low skin test reactivity after VIT may be interesting for future investigations that assess its role as a potential marker for VIT efficacy. © 2017 S. Karger AG, Basel.

  20. Sensitization to aeroallergens in patients with respiratory allergies based on skin-prick test results.

    PubMed

    Lokaj-Berisha, V; Berisha, N; Lumezi, B; Ahmetaj, L; Bejtullahu, G; Karahoda, N; Pupovci, H

    2012-01-01

    The aim of this study was to identify the most common aeroallergens in patients with asthma and rhinitis. The study enrolled 102 participants including 64 patients with respiratory allergies (among them 15 were clinically diagnosed as asthma patients, 41 with rhinitis, 8 were both) and 38 healthy controls. All of participants were subject of skin prick tests (SPT) with series of common allergenic extracts. Sera from all participants were tested for total IgE and eosinophil count. To measure airflow limitation and reversibility in asthma patients the pulmonary function testing were carried out. M/F ratio was 1:1.6 in patients and 1:0.7 in control group with mean age 28.88 year (SD 13.16; range 6 - 55 year) and 20.47 respectively (SD 1.16; range 19-23 year). The most common risk factors in these patients were total IgE more than 100 IU/ml, eosinophils above 4% and positive family history of atopy. Skin prick testing results showed prevalence rates for allergen groups in this manner: house dust mites 81.3 %, pollens 57.8 %, animal dandruff 12.5% and moulds 4.9%. Polysensitization was common in 51.6% of all sensitized patients being positive to more than one group of allergens. House dust mites are the main sensitizing allergens among our allergic patients as well as healthy controls. Next in importance, in all participants, are grasses. This pattern of prevalence was expected based on herbal geography, climate and specially lifestyle. It was also compatible with the results from studies carried out in places with the same habitat.