title: A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: eye irritation.
abstract: The need for alternative approaches to replace the in vivo rabbit Draize eye test for evaluation of eye irritation of cosmetic ingredients has been recognised by the cosmetics industry for many years. Extensive research has lead to the development of several assays, some of which have undergone formal validation. Even though, to date, no single in vitro assay has been validated as a full replacement for the rabbit Draize eye test, organotypic assays are accepted for specific and limited regulatory purposes. Although not formally validated, several other in vitro models have been used for over a decade by the cosmetics industry as valuable tools in a weight of evidence approach for the safety assessment of ingredients and finished products. In light of the deadlines established in the EU Cosmetics Directive for cessation of animal testing for cosmetic ingredients, a COLIPA scientific meeting was held in Brussels on 30th January, 2008 to review the use of alternative approaches and to set up a decision-tree approach for their integration into tiered testing strategies for hazard and safety assessment of cosmetic ingredients and their use in products. Furthermore, recommendations are given on how remaining data gaps and research needs can be addressed.
authors.affiliation: Procter & Gamble, Rusham Park Technical Centre, Whitehall Lane, Egham, Surrey TW20 9NW, UK.
authors.forename: Pauline
authors.initials: P
authors.lastname: McNamee
authors.forename: Jalila
authors.initials: J
authors.lastname: Hibatallah
authors.forename: Margit
authors.initials: M
authors.lastname: Costabel-Farkas
authors.forename: Carsten
authors.initials: C
authors.lastname: Goebel
authors.forename: Daisuke
authors.initials: D
authors.lastname: Araki
authors.forename: Eric
authors.initials: E
authors.lastname: Dufour
authors.forename: Nicola J
authors.initials: NJ
authors.lastname: Hewitt
authors.forename: Penny
authors.initials: P
authors.lastname: Jones
authors.forename: Annette
authors.initials: A
authors.lastname: Kirst
authors.forename: Béatrice
authors.initials: B
authors.lastname: Le Varlet
authors.forename: Martin
authors.initials: M
authors.lastname: Macfarlane
authors.forename: Monique
authors.initials: M
authors.lastname: Marrec-Fairley
authors.forename: Joanna
authors.initials: J
authors.lastname: Rowland
authors.forename: Florian
authors.initials: F
authors.lastname: Schellauf
authors.forename: Julia
authors.initials: J
authors.lastname: Scheel
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D003226:Congresses as Topic; D003257:Consumer Product Safety; D003358:Cosmetics / Q000009:adverse effects* / Q000592:standards; D003663:Decision Trees; D005123:Eye / Q000187:drug effects*; D006801:Humans; D007509:Irritants / Q000009:adverse effects*
chemical_list: D003358:Cosmetics; D007509:Irritants