Article ID Journal Published Year Pages File Type
5861260 Toxicology in Vitro 2016 13 Pages PDF
Abstract

•The SENS-IS assay quantifies skin sensitization potency.•The SENS-IS assay is easily transferable.•The ring study shows excellent reproducibility over 90%.•Specificity, sensitivity and accuracy, analyzed on 150 chemicals, were above 90%.

The SENS-IS test protocol for the in vitro detection of sensitizers is based on a reconstructed human skin model (Episkin) as the test system and on the analysis of the expression of a large panel of genes. Its excellent performance was initially demonstrated with a limited set of test chemicals. Further studies (described here) were organized to confirm these preliminary results and to obtain a detailed statistical analysis of the predictive capacity of the assay. A ring-study was thus organized and performed within three laboratories, using a test set of 19 blind coded chemicals. Data analysis indicated that the assay is robust, easily transferable and offers high predictivity and excellent within- and between-laboratories reproducibility. To further evaluate the predictivity of the test protocol according to Cooper statistics a comprehensive test set of 150 chemicals was then analyzed. Again, data analysis confirmed the excellent capacity of the SENS-IS assay for predicting both hazard and potency characteristics, confirming that this assay should be considered as a serious alternative to the available in vivo sensitization tests.

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Life Sciences Environmental Science Health, Toxicology and Mutagenesis
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