title: A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: skin irritation.
abstract: Evaluation of the skin irritancy and corrosivity potential of an ingredient is a necessity in the safety assessment of cosmetic ingredients. To date, there are two formally validated alternatives to the rabbit Draize test for skin corrosivity in place, namely the rat skin transcutaneous electrical resistance (TER) assay and the Human Skin Model Test using EpiSkin, EpiDerm and SkinEthic reconstructed human epidermal equivalents. For skin irritation, EpiSkin, EpiDerm and SkinEthic are validated as stand-alone test replacements for the rabbit Draize test. Data from these tests are rarely considered in isolation and are evaluated in combination with other factors to establish the overall irritating or corrosive potential of an ingredient. In light of the deadlines established in the 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. In conclusion, the safety assessments for skin irritation/corrosion of new chemicals for use in cosmetics can be confidently accomplished using exclusively alternative methods.
authors.affiliation: Unilever, Colworth Science Park, Sharnbrook, Bedford MK44 1LQ, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Macfarlane
authors.forename: Penny
authors.initials: P
authors.lastname: Jones
authors.forename: Carsten
authors.initials: C
authors.lastname: Goebel
authors.forename: Eric
authors.initials: E
authors.lastname: Dufour
authors.forename: Joanna
authors.initials: J
authors.lastname: Rowland
authors.forename: Daisuke
authors.initials: D
authors.lastname: Araki
authors.forename: Margit
authors.initials: M
authors.lastname: Costabel-Farkas
authors.forename: Nicola J
authors.initials: NJ
authors.lastname: Hewitt
authors.forename: Jalila
authors.initials: J
authors.lastname: Hibatallah
authors.forename: Annette
authors.initials: A
authors.lastname: Kirst
authors.forename: Pauline
authors.initials: P
authors.lastname: McNamee
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; D006801:Humans; D012867:Skin / Q000187:drug effects*; D023422:Skin Irritancy Tests / Q000379:methods*
chemical_list: D003358:Cosmetics