title: Guiding principles for the implementation of non-animal safety assessment approaches for cosmetics: skin sensitisation.
abstract: Characterisation of skin sensitisation potential is a key endpoint for the safety assessment of cosmetic ingredients especially when significant dermal exposure to an ingredient is expected. At present the mouse local lymph node assay (LLNA) remains the 'gold standard' test method for this purpose however non-animal test methods are under development that aim to replace the need for new animal test data. COLIPA (the European Cosmetics Association) funds an extensive programme of skin sensitisation research, method development and method evaluation and helped coordinate the early evaluation of the three test methods currently undergoing pre-validation. In May 2010, a COLIPA scientific meeting was held to analyse to what extent skin sensitisation safety assessments for cosmetic ingredients can be made in the absence of animal data. In order to propose guiding principles for the application and further development of non-animal safety assessment strategies it was evaluated how and when non-animal test methods, predictions based on physico-chemical properties (including in silico tools), threshold concepts and weight-of-evidence based hazard characterisation could be used to enable safety decisions. Generation and assessment of potency information from alternative tools which at present is predominantly derived from the LLNA is considered the future key research area.
authors.affiliation: Procter & Gamble, Berliner Allee 65, 64274 Darmstadt, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Goebel
authors.forename: Pierre
authors.initials: P
authors.lastname: Aeby
authors.forename: Nadège
authors.initials: N
authors.lastname: Ade
authors.forename: Nathalie
authors.initials: N
authors.lastname: Alépée
authors.forename: Aynur
authors.initials: A
authors.lastname: Aptula
authors.forename: Daisuke
authors.initials: D
authors.lastname: Araki
authors.forename: Eric
authors.initials: E
authors.lastname: Dufour
authors.forename: Nicola
authors.initials: N
authors.lastname: Gilmour
authors.forename: Jalila
authors.initials: J
authors.lastname: Hibatallah
authors.forename: Detlef
authors.initials: D
authors.lastname: Keller
authors.forename: Petra
authors.initials: P
authors.lastname: Kern
authors.forename: Annette
authors.initials: A
authors.lastname: Kirst
authors.forename: Monique
authors.initials: M
authors.lastname: Marrec-Fairley
authors.forename: Gavin
authors.initials: G
authors.lastname: Maxwell
authors.forename: Joanna
authors.initials: J
authors.lastname: Rowland
authors.forename: Bob
authors.initials: B
authors.lastname: Safford
authors.forename: Florian
authors.initials: F
authors.lastname: Schellauf
authors.forename: Andreas
authors.initials: A
authors.lastname: Schepky
authors.forename: Chris
authors.initials: C
authors.lastname: Seaman
authors.forename: Thomas
authors.initials: T
authors.lastname: Teichert
authors.forename: Nicolas
authors.initials: N
authors.lastname: Tessier
authors.forename: Silvia
authors.initials: S
authors.lastname: Teissier
authors.forename: Hans Ulrich
authors.initials: HU
authors.lastname: Weltzien
authors.forename: Petra
authors.initials: P
authors.lastname: Winkler
authors.forename: Julia
authors.initials: J
authors.lastname: Scheel
mesh_terms: D000485:Allergens / Q000633:toxicity*; D000826:Animal Testing Alternatives; D003257:Consumer Product Safety; D003358:Cosmetics / Q000633:toxicity*; D006967:Hypersensitivity / Q000209:etiology*; D018570:Risk Assessment / Q000379:methods; D012867:Skin / Q000187:drug effects* / Q000276:immunology
chemical_list: D000485:Allergens; D003358:Cosmetics