A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: genotoxicity. A COLIPA analysis.
Regul Toxicol Pharmacol
; 57(2-3): 315-24, 2010.
Article
en En
| MEDLINE
| ID: mdl-20382194
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.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Seguridad de Productos para el Consumidor
/
Cosméticos
/
Alternativas a las Pruebas en Animales
/
Mutágenos
Tipo de estudio:
Diagnostic_studies
/
Prognostic_studies
Límite:
Animals
/
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Año:
2010
Tipo del documento:
Article
País de afiliación:
Estados Unidos