THE USE OF HUMAN 3D EPIDERMAL MODELS FOR GENOTOXICITY TESTING: RESULTS WITH THE COMET ASSAY.
EU policy, including REACH and the Cosmetics Directive, implies the urgent need for reliable in vitro strategies with regards to the safety evaluation of chemicals. Currently used in vitro assays are not sufficiently suitable to reliably evaluate substances, for example cosmetic ingredients, for which the skin is the primary route of exposure. Therefore, genotoxicity assays using human 3D epidermal models were developed, representing a relevant test system with regards to barrier function of the stratum corneum and the possibility to apply formulations.
Comet assay, EpiDerm™, Genotoxicity, Intra-lab reproducibility, Validation study
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