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 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.