A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Genotoxicity. A COLIPA analysis

Abstract

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 EU Cosmetics 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.

Consensus report on the future of animal-free systemic toxicity testing

“…Alternative methods for the determination of genotoxicity have been in use for over 40 years. An ItS has been suggested to combine such available methods (Pfuhler et al, 2010;Aldenberg and Jaworska, 2010). testing for non-genotoxic carcinogens has proven more difficult, but good results have been obtained recently by various cell transformation assays (Vanparys et al, 2011).…”

A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing

“…This means a comprehensive testing strategy, designed to complement an optimized genotoxicity testing toolbox, must integrate more and more mechanisms and modes of action. There are already suggestions, however, for how to generate ITS for genotoxicity (Pfuhler et al, 2010b;Aldenberg and Jaworska, 2010).…”

Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US

“…CTAs are considered to provide additional useful information to more routinely employed tests for assessing carcinogenic potential and are therefore listed in various recent guidelines and testing strategies for such purposes (SCCP, 2010 28 ;Jacobson-Kram and Jacobs, 2005;EC, 2008;Pfuhler et al, 2010). Since regulatory agencies may receive and review CTA data and these assays are used for internal risk assessment of various chemicals, there was a need within the scientific community for standardization of these test methods and technical guidance on their conduct and use.…”