A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Genotoxicity. A COLIPA analysis
| Autor: | Norbert Dr Banduhn, Carsten Goebel, Kerstin Reisinger, James Harvey, Rolf Fautz, Daisuke Araki, Paul L. Carmichael, Stefan Pfuhler, Joanna Rowland, Annette Kirst, Florian Schellauf, Marilyn J. Aardema, Nicola J. Hewitt, Jalila Hibatallah, Margit Costabel-Farkas, Andreas Schepky, Eric K. Dufour, Martin Macfarlane, Julia Scheel |
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| Rok vydání: | 2010 |
| Předmět: |
Consumer Product Safety
In vitro genotoxicity media_common.quotation_subject Alternatives to animal testing Cosmetics Animal Testing Alternatives medicine.disease_cause Toxicology Sensitivity and Specificity Animals Humans Medicine media_common Alternative methods Mutagenicity Tests business.industry In vitro toxicology General Medicine Tiered approach Biotechnology Europe Research Design Safety assessment Cosmetic ingredients Genotoxicity business Hazard assessment Mutagens |
| Zdroj: | Regulatory Toxicology and Pharmacology. 57(2-3):315-324 |
| ISSN: | 0273-2300 |
| DOI: | 10.1016/j.yrtph.2010.03.012 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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