Benchmarking performance of SENS-IS assay against weight of evidence skin sensitization potency categories

Potency determination of potential skin sensitizers in humans is essential for quantitative risk assessment and proper risk management. SENS-IS is an in vitro test based on a reconstructed human skin model, that was developed to predict the hazard and potency of potential skin sensitizers. The perfo...

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Published in:Regulatory toxicology and pharmacology 2022-04, Vol.130, p.105128-105128, Article 105128
Main Authors: Na, Mihwa, O'Brien, Devin, Gerberick, G. Frank, Kern, Petra S., Lavelle, Maura, Lee, Isabelle, Parakhia, Rahul, Ryan, Cindy, Api, Anne Marie
Format: Article
Language:English
Subjects:
Animal alternative
Animal Testing Alternatives
Animals
Dermatitis, Allergic Contact - pathology
Dose-Response Relationship, Drug
Fragrance materials
Humans
In vitro assay
In Vitro Techniques
Irritants - toxicity
Models, Biological
Potency prediction
Reproducibility of Results
Skin sensitization
Toxicity Tests
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Summary:Potency determination of potential skin sensitizers in humans is essential for quantitative risk assessment and proper risk management. SENS-IS is an in vitro test based on a reconstructed human skin model, that was developed to predict the hazard and potency of potential skin sensitizers. The performance of the SENS-IS assay in potency prediction for 174 materials was evaluated for this work. The potency used as a benchmark was determined based on the weight of evidence approach, by collectively considering all well-established test data, including human, animal, in chemico, in vitro, and in silico data. Based on this weight of evidence approach, the dataset was composed of 5, 19, 34, 54, and 38 extreme, strong, moderate, weak, and very weak sensitizers, respectively, as well as 24 non-sensitizers. SENS-IS provided good prediction of the skin sensitization potency for 85% of this dataset, with precise and approximate prediction on 46% and 39% of the 174 materials, respectively. Our evaluation showed that SENS-IS provides a good approximation of the skin sensitization potency. •Potency information is essential for quantitative risk assessment and management.•In this work, SENS-IS data on a total of 174 materials were evaluated.•Weight of evidence-based potency was used as a benchmark.•SENS-IS provided a good insight on skin sensitization potency.
ISSN:0273-2300
1096-0295
DOI:10.1016/j.yrtph.2022.105128