title: Skin sensitisation: the Colipa strategy for developing and evaluating non-animal test methods for risk assessment.
abstract: Allergic contact dermatitis is a delayed-type hypersensitivity reaction induced by small reactive chemicals (haptens). Currently, the sensitising potential and potency of new chemicals is usually characterised using data generated via animal studies, such as the local lymph node assay (LLNA). There are, however, increasing public and political concerns regarding the use of animals for the testing of new chemicals. Consequently, the development of in vitro, in chemico or in silico models for predicting the sensitising potential and/or potency of new chemicals is receiving widespread interest. The Colipa Skin Tolerance task force currently collaborates with and/or funds several academic research groups to expand our understanding of the molecular and cellular events occurring during the acquisition of skin sensitisation. Knowledge gained from this research is being used to support the development and evaluation of novel alternative approaches for the identification and characterisation of skin sensitizing chemicals. At present three non-animal test methods (Direct Peptide Reactivity Assay (DPRA), Myeloid U937 Skin Sensitisation Test (MUSST) and human Cell Line Activation Test (hCLAT)) have been evaluated in Colipa interlaboratory ring trials for their potential to predict skin sensitisation potential and were recently submitted to ECVAM for formal pre-validation. Data from all three test methods will now be used to support the study and development of testing strategy approaches for skin sensitiser potency prediction. This publication represents the current viewpoint of the cosmetics industry on the feasibility of replacing the need for animal test data for informing skin sensitisation risk assessment decisions.
authors.affiliation: Safety and Environmental Assurance Centre, Unilever Colworth, Sharnbrook, UK. Gavin.maxwell@unilever.com
authors.forename: Gavin
authors.initials: G
authors.lastname: Maxwell
authors.forename: Pierre
authors.initials: P
authors.lastname: Aeby
authors.forename: Takao
authors.initials: T
authors.lastname: Ashikaga
authors.forename: Sandrine
authors.initials: S
authors.lastname: Bessou-Touya
authors.forename: Walter
authors.initials: W
authors.lastname: Diembeck
authors.forename: Frank
authors.initials: F
authors.lastname: Gerberick
authors.forename: Petra
authors.initials: P
authors.lastname: Kern
authors.forename: Monique
authors.initials: M
authors.lastname: Marrec-Fairley
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Ovigne
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sakaguchi
authors.forename: Klaus
authors.initials: K
authors.lastname: Schroeder
authors.forename: Magali
authors.initials: M
authors.lastname: Tailhardat
authors.forename: Silvia
authors.initials: S
authors.lastname: Teissier
authors.forename: Petra
authors.initials: P
authors.lastname: Winkler
mesh_terms: D000485:Allergens / Q000633:toxicity; D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D015415:Biomarkers; D002460:Cell Line; D003358:Cosmetics / Q000592:standards; D003713:Dendritic Cells / Q000187:drug effects; D017449:Dermatitis, Allergic Contact / Q000473:pathology*; D006241:Haptens; D006801:Humans; D007221:Industry / Q000592:standards; D018570:Risk Assessment; D012867:Skin / Q000473:pathology
chemical_list: D000485:Allergens; D015415:Biomarkers; D003358:Cosmetics; D006241:Haptens