575. A TIERED APPROACH TO THE USE OF ALTERNATIVES TO ANIMAL TESTING FOR THE SAFETY ASSESSMENT OF COSMETICS: GENOTOXICITY. A COLIPA ANALYSIS.

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Pfuhler¹, S., Kirst², A., Aardema¹, M., Banduhn³, N., Goebel⁴, C., Araki⁵, D., Costabel-Farkas⁶, M., Dufour⁷, E., Fautz², R., Harvey⁸, J., Hewitt⁹, N.J., Hibatallah¹⁰, J., Carmichael¹¹, P., Macfarlane¹¹, M., Reisinger³, K., Rowland¹², J., Schellauf¹³, F., Schepky¹⁴, A., Scheel3, J. ¹Procter & Gamble, Miami Valley Laboratories, 11810 East Miami River Road, Cincinnati, 45253 OH, USA. ²KPSS – Kao Professional Salon Services GmbH, Pfungstaedter Strasse 92-100, 64297 Darmstadt, Germany. ³Henkel AG & Co. KGaA, Henkelstraße 67, 40589 Düsseldorf, Germany. ⁴Procter & Gamble, Darmstadt Innovation Center, Berliner Allee 65, 64274 Darmstadt, Germany. ⁵Kanebo Cosmetics, 89/91 Rue du Faubourg St Honoré, 75008 Paris, France. ⁶Johnson & Johnson GmbH, Johnson&Johnson-Platz 2, D-41470 Neuss, Germany. ⁷L’Oreal, River Plaza 25-29, quai Aulagnier 92600 Asnières-sur-Seine, France. ⁸GlaxoSmithKline R&D, Ware, Hertfordshire, UK.⁹Scientific Writing Services, Wingertstrasse 25, 64390 Erzhausen, Germany. ¹⁰Chanel Parfums Beaute 135, Avenue Charles de Gaulle, 92525 Neuilly sur Seine, France. ¹¹Unilever, Colworth Science Park, Sharnbrook, Bedford MK44 1LQ, UK. ¹²GlaxoSmithKline Consumer HealthCare R&D, Weybridge, Surrey KT13 ODE, UK. ¹³COLIPA, Avenue Herrmann Debroux 15A, B-1160 Auderghem, Brussels, Belgium. ¹⁴Beiersdorf AG, BF 682, Unnastrasse 48, 20245 Hamburg, Germany. Regulatory Toxicol. and Pharmacol., 57, 315-324, (2010).

Summary:
 For the assessment of genotoxic effects of cosmetic ingredients, a number of well-established and regulatory accepted in vitro assays are in place.
 A caveat to the use of these assays is their relatively low specificity and high rate of false or misleading positive results. Due to the 7th amendment to the EUCosmetics Directive ban on in vivo genotoxicity testing for cosmetics that was enacted March 2009, it is no longer possible to conduct follow-up in vivo genotoxicity tests for cosmetic ingredients positive in in vitro genotoxicity tests to further assess the relevance of the in vitro findings. COLIPA, the European Cosmetics Association, has initiated a research programme to improve existing and develop new in vitro methods.
 A COLIPA workshop was held in Brussels in April 2008 to analyse the best possible use of available methods and approaches to enable a sound assessment of the genotoxic hazard of cosmetic ingredients. Common approaches of cosmetic companies are described, with recommendations for evaluating in vitro genotoxins using non-animal approaches. A weight of evidence approach was employed to set up a decision-tree for the integration of alternative methods into tiered testing strategies.
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