Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
11025655 | Toxicology in Vitro | 2019 | 43 Pages |
Abstract
Predictive capacity of the EpiSkin⢠model was evaluated on 87 chemicals using the Bottom-Up and the Top-Down testing approaches recommended within Integrated Approach on Testing and Assessment for the identification of both skin irritation and corrosion hazards. Classified (UN GHS Cat. 1 and Cat. 2) chemicals were identified with a very high sensitivity (â¥94%) and the non-classified (UN GHS Cat. 3 and No Cat.) chemicals with an appropriate specificity (70%). Very high sensitivities were obtained for the identification of Cat. 1 chemicals (â¥98%), very high specificities for non-Cat. 1 chemicals (93%), and accuracies of â95% for the identification of skin corrosives vs. non-corrosives by both approaches. Overall accuracies of 72% were found for predicting the single (sub)categories: non-classified, Cat. 2, Subcat. 1B/1C and Subcat. 1A. Results indicated the testing strategies to be more predictive than the individual assays on a conservative safety approach. Finally, no extreme misclassifications (no under-prediction of in vivo Subcat. 1A as non-Cat. 1, and no over-prediction of non-classified chemical as Subcat. 1A) occur. These findings, independently of the approach used, confirm the usefulness of the EpiSkin⢠in vitro model for a safe prediction of the skin irritant and corrosive hazards of chemicals.
Keywords
PBSguidance documentSCVSCATEURL ECVAMSOPECVAM Scientific Advisory CommitteeCAS RNEU CLPESACμLOECDUN GHSMTTEuropean Union Reference Laboratory for Alternatives to Animal TestingEuropean UnionTop-downNo CatPercentCategoryTest guidelinesChemical Abstracts Service Registry Numberstandard operating procedureUnited Nations Globally Harmonized System of Classification and Labelling of ChemicalsOrganization for Economic Co-operation and DevelopmentDulbecco's phosphate-buffered salineMillilitreMicroliterBottom-upoptical densityIATA
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Authors
Nathalie Alépée, Marie-Hélène Grandidier, José Cotovio,