title: 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.
authors.affiliation: Procter & Gamble, Miami Valley Laboratories, Cincinnati, OH 45253, USA.
authors.forename: Stefan
authors.initials: S
authors.lastname: Pfuhler
authors.forename: Annette
authors.initials: A
authors.lastname: Kirst
authors.forename: Marilyn
authors.initials: M
authors.lastname: Aardema
authors.forename: Norbert
authors.initials: N
authors.lastname: Banduhn
authors.forename: Carsten
authors.initials: C
authors.lastname: Goebel
authors.forename: Daisuke
authors.initials: D
authors.lastname: Araki
authors.forename: Margit
authors.initials: M
authors.lastname: Costabel-Farkas
authors.forename: Eric
authors.initials: E
authors.lastname: Dufour
authors.forename: Rolf
authors.initials: R
authors.lastname: Fautz
authors.forename: James
authors.initials: J
authors.lastname: Harvey
authors.forename: Nicola J
authors.initials: NJ
authors.lastname: Hewitt
authors.forename: Jalila
authors.initials: J
authors.lastname: Hibatallah
authors.forename: Paul
authors.initials: P
authors.lastname: Carmichael
authors.forename: Martin
authors.initials: M
authors.lastname: Macfarlane
authors.forename: Kerstin
authors.initials: K
authors.lastname: Reisinger
authors.forename: Joanna
authors.initials: J
authors.lastname: Rowland
authors.forename: Florian
authors.initials: F
authors.lastname: Schellauf
authors.forename: Andreas
authors.initials: A
authors.lastname: Schepky
authors.forename: Julia
authors.initials: J
authors.lastname: Scheel
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D003257:Consumer Product Safety; D003358:Cosmetics / Q000592:standards / Q000633:toxicity*; D005060:Europe; D006801:Humans; D009152:Mutagenicity Tests / Q000379:methods / Q000592:standards; D009153:Mutagens / Q000633:toxicity*; D012107:Research Design; D012680:Sensitivity and Specificity
chemical_list: D003358:Cosmetics; D009153:Mutagens