The Cosmetics Europe strategy for animal-free genotoxicity testing: project status up-date

S. Pfuhler1, R. Fautz2, G. Ouedraogo3, A. Latil4, J. Kenny5, C. Moore6, W. Diembeck7, N.J. Hewitt8, K. Reisinger9, J. Barroso1,10, Procter & Gamble Co., 1Procter and Gamble Plz, Cincinnati, OH, USA, 2Kao Germany GmbH, Pfungstädterstraße 92 – 100, D-64297 Darmstadt, Germany, 3L’Oreal Life Sciences Research, Aulnay sous Bois, France, 4Pierre Fabre, 3 Rue des satellites, 31432 Toulouse, France, 5GSK, Park Road, Ware, SG12 ODP, UK, 6Unilever, Colworth House, Sharnbrook, Bedford, MK44 1LQ, UK, 7Beiersdorf AG, Unnastrasse 4, D-20253 Hamburg, Germany, 8SWS,Wingertstrasse 25, D-64390 Erzhausen, Germany, 9Henkel AG & Co., KGaA, Henkelstraße 67, D-40191 Duesseldorf, Germany, 10Cosmetics Europe, Avenue Herrmann Debroux 40, B-1160 Auderghem, Brussels, Belgium.

The Cosmetics Europe (formerly COLIPA) Genotoxicity Task Force has driven and funded three projects to help address the high rate of misleading positives in in vitro genotoxicity tests: The completed “False Positives” project optimized current mammalian cell assays and showed that the predictive capacity of the in vitro micronucleus assay was improved dramatically by selecting more relevant cells and more sensitive toxicity measures. The on-going “3D skin model” project has been developed and is now validating the use of human reconstructed skin (RS) models in combination with the micronucleus (MN) and Comet assays. These models better reflect the in use conditions of dermally applied products, such as cosmetics. Both assays have demonstrated good inter- and intra-laboratory reproducibility and are entering validation stages. The completed “Metabolism” project investigated enzyme capacities of human skin and RS models. The RS models were shown to have comparable metabolic capacity to native human skin, confirming their usefulness for testing of compounds with dermal exposure. The program has already helped to improve the initial test battery predictivity and the RS projects have provided sound support for their use as a follow-up test in the assessment of the genotoxic hazard of cosmetic ingredients in the absence of in vivo data.


Cosmetics Europe, genotoxicity, false positives, micronucleus assay, comet assay, validation, reproducibility, metabolic activation, EpiDerm (EPI-200-MNA), EPI-201, cytochrome P450s, sulfotransferases (SULTs), UDPGA-glucuronosyltransferases (UGTs), glutathione S-transferases, alcohol dehydrogenases, aldehyde dehydrogenases, amine oxidases, epoxide hydrolases, CYP1A/1B pathway, cosmetics

Materials Tested

4-nitroquinoline-n-oxide (4NQO), cyclophosphamide, dimethylbenzanthracene (DMBA), dimethylnitrosamine(DMN), dibenzanthracene (DBA), benzo[a]pyrene (BaP), methyl methane sulfonate (MMS)

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