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COLIPA VALIDATION OF THE RECONSTRUCTED HUMAN SKIN MICRONUCLEUS ASSAY (RSMN): FURTHER PRE-VALIDATION STUDIES AND INVESTIGATIONS IN INCREASING TIME EFFICIENCY.

Fautz1, R., Ouedraogo2, G., Reisinger3, K., Aardema4, M., Barnett5, B., Faquet2, B., Mun6, G., Dahl6,  E., Curren6, R., Hewitt7, N. and Pfuhler5, S. 1KPSS-Kao Professional Salon Services, Darmstadt, Germany; 2L’Oreal Life Sciences Research, Aulnay sous Bois, France; 3Henkel AG & Co KGaA, Duesseldorf, Germany; 4Bioreliance, Rockville, MD, USA, 5The Procter & Gamble Co., Cincinnati, OH, USA, 6Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA; 7Erzhausen, Germany
Abstract

The European Cosmetics Association (COLIPA) has initiated a multi-laboratory project to establish and evaluate more predictive in vitro genotoxicity assays using 3D human tissues as replacements for current mammalian cell in vitro genotoxicity assays, which induce high levels of false positives. The reconstructed skin (RS) model, EpiDermTM, was combined with the micronucleus (MN) and comet assays to mimic the most relevant route of exposure to many different products, including cosmetics. Results from the RS Comet assay are shown in a poster by Krul et al. [1] (Abstract number I-10-207). Results from Phase 1 and 2 of the RSMN assay COLIPA project are shown here. The resulting RSMN model offers the potential for a more realistic application/metabolism of test compounds for evaluating genotoxicity [2,3].

Keywords

Comet assays, EpiDermTM, European Cosmetics Association (COLIPA), Genotoxicity assays, Inter-laboratory reproducibility, Intra-laboratory reproducibility, Micronucleus assay (MN), Pre-validation, Transferability

Materials Tested

Cyclohexanone, Mitomycin C, N-ethyl-N-nitrosourcea, Vinblastin sulfate

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