Comparison of human skin irritation patch test data with <i>in vitro</i> skin irritation assays and animal data

Jírová, Dagmar; Basketter, David A.; Liebsch, Manfred; Bendová, Hana; Kejlová, Kristína; Marriott, Marie; Kanďárová, Helena

doi:10.1111/j.1600-0536.2009.01640.x

Cited by 82 publications

(32 citation statements)

References 24 publications

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“…These data have been collated from three main publications (Robinson et al , 2001; Basketter et al , 2004; Jirova et al , 2010). Table 1 also reports the proportion of test subjects reacting to the test substance as well as their response to the concurrent 20% SDS positive control.…”

Section: Resultsmentioning

confidence: 99%

“…Based on in vivo rabbit tests, more than 50% of chemicals are classified as irritants in Table 1 (Robinson et al , 2001; Basketter et al , 2004; Jirova et al , 2010), wheras in the human patch test, using the classification critiera described earlier, only about 20% of the substances tested were identified as human irritants, with two possible corrosive classifications (#45 Lactic Acid; #67 0.5% Sodium Hydroxide).…”

Section: Resultsmentioning

confidence: 99%

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Review of skin irritation/corrosion hazards on the basis of human data: a regulatory perspective

Basketter¹,

Jírová²,

Kanďárová³

2012

Interdisciplinary Toxicology

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Regulatory classification of skin irritation has historically been based on rabbit data, however current toxicology processes are transitioning to in vitro alternatives. The in vitro assays have to provide sufficient level of sensitivity as well as specificity to be accepted as replacement methods for the existing in vivo assays. This is usually achieved by comparing the in vitro results to classifications obtained in animals. Significant drawback of this approach is that neither in vivo nor in vitro methods are calibrated against human hazard data and results obtained in these assays may not correspond to situation in human.The main objective of this review was to establish an extended database of substances classified according to their human hazard to serve for further development of alternative methods relevant to human health as well as resource for improved regulatory classification. The literature has been reviewed to assemble all the available information on the testing of substances in the human 4 h human patch test, which is the only standardized protocol in humans matching the exposure conditions of the regulatory accepted in vivo rabbit skin irritation test.A total of 81 substances tested according to the defined 4 h human patch test protocol were found and collated into a dataset together with their existing in vivo classifications published in the literature. While about 50% of the substances in the database are classified as irritating based on the rabbit skin test, on using the 4 h HPT test, less than 20% were identified as acutely irritant to human skin. Based on the presented data, it can be concluded that the rabbit skin irritation test largely over-predicts human responses for the evaluated chemicals. Correct classification of the acute skin irritation hazard will only be possible if newly developed in vitro toxicology methods will be calibrated to produce results relevant to man.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Review of skin irritation/corrosion hazards on the basis of human data: a regulatory perspective

Basketter¹,

Jírová²,

Kanďárová³

2012

Interdisciplinary Toxicology

Self Cite

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“…However, results of in vitro tests may not be directly related to human reaction in vivo as the bioavailability may differ and other toxicological data should be obtained.…”

Section: Discussionmentioning

confidence: 99%

Preliminary safety assessment of C–8 xylitol monoester and xylitol phosphate esters

Silveira

Pereda

Nogueira

et al. 2015

Intern J of Cosmetic Sci

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“…Rabbits have been traditionally used as preclinical species to test the dermal irritation potential of chemical in humans; however, as rabbits tend to over predict the skin effects in humans (Jírová et al, 2010;Nixon et al, 1975;Phillips et al, 1972;York et al, 1996), false-positive data may result in deselecting a potentially useful formulation or vehicle. In addition to high (hair) follicular density in rabbits, a comparative profile of human and rabbit skin reveals significant differences between the two species skin such as, epidermal lipid composition, epidermal thickness and skin surface pH.…”

Section: Discussionmentioning

confidence: 99%

Dermal irritation of petrolatum in rabbits but not in mice, rats or minipigs

Chandra

Peterson

Melich

et al. 2013

J of Applied Toxicology

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Petrolatum is widely used in cosmetics, topical pharmaceuticals and also as a vehicle in dermal toxicity studies. New Zealand white rabbits treated with white petrolatum (vehicle control) in a 2-week dermal irritation study exhibited moderate to severe erythema starting on Day 7 that subsided towards the end of the study. Histological examination of abraded and non-abraded petrolatum-treated skin obtained at termination (Day 15) revealed mild acanthosis, hyperkeratosis, dermal edema with mixed inflammatory cells in the dermis. Macroscopic and microscopic features noted in rabbits were consistent with dermal irritation to petrolatum. Wistar-Han rats, CD1 mice, C57/Bl/6J mice and Göttingen minipigs treated topically with white petrolatum did not exhibit clinical or histologic evidence of dermal irritation. Therapeutic agents developed for topical application are generally tested in rabbits during some point in development. Interpretation of skin irritation data from a single species can impact risk assessment for humans and on product labeling.

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

Abstract: 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.

Cited by 82 publications

References 24 publications

Review of skin irritation/corrosion hazards on the basis of human data: a regulatory perspective

Review of skin irritation/corrosion hazards on the basis of human data: a regulatory perspective

Preliminary safety assessment of C–8 xylitol monoester and xylitol phosphate esters

Dermal irritation of petrolatum in rabbits but not in mice, rats or minipigs

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