A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: skin irritation.
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.
Macfarlane
Martin
M
Unilever, Colworth Science Park, Sharnbrook, Bedford MK44 1LQ, UK.
Jones
Penny
P
Goebel
Carsten
C
Dufour
Eric
E
Rowland
Joanna
J
Araki
Daisuke
D
Costabel-Farkas
Margit
M
Hewitt
Nicola J
NJ
Hibatallah
Jalila
J
Kirst
Annette
A
McNamee
Pauline
P
Schellauf
Florian
F
Scheel
Julia
J
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*
D003358:Cosmetics