Usefulness of the EpiSkin™ reconstructed human epidermis model within Integrated Approaches on Testing and Assessment (IATA) for skin corrosion and irritation

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)...

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Bibliographic Details
Published in:Toxicology in vitro 2019-02, Vol.54, p.147-167
Main Authors: Alépée, Nathalie, Grandidier, Marie-Hélène, Cotovio, José
Format: Article
Language:English
Subjects:
Animal Testing Alternatives
Biological Assay
Caustics - toxicity
Chemicals
Corrosion
Epidermis
Epidermis - drug effects
Hazard assessment
Hazard identification
Human exposure
Humans
In vivo methods and tests
Irritants - toxicity
Irritation
Mathematical models
Organic chemistry
Predictions
Reproducibility of Results
Sensitivity
Skin
Skin Irritancy Tests
Toxicology
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Summary: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 (≥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 (≥98%), very high specificities for non-Cat. 1 chemicals (93%), and accuracies of −95% 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. •OECD adopted an Integrated Approach on Testing and Assessment (IATA) for skin corrosion and skin irritation.•The study aimed to evaluate the in vitro EpiSkin ‘s test methods.•Data on 87 substances were obtained for skin irritation and skin corrosion.•High sensitivity (> 90%) and appropriate specificity (>70%) were observed.•The classification of substances is allowed according to EU CLP and UN GHS.
ISSN:0887-2333
1879-3177
DOI:10.1016/j.tiv.2018.09.015