title: Systematic evaluation of non-animal test methods for skin sensitisation  safety assessment.
abstract: The need for non-animal data to assess skin sensitisation properties of substances, especially cosmetics ingredients, has spawned the development of many in vitro methods. As it is widely believed that no single method can provide a solution, the Cosmetics Europe Skin Tolerance Task Force has defined a three-phase framework for the development of a non-animal testing strategy for skin sensitization potency prediction. The results of the first phase – systematic evaluation of 16 test methods – are presented here. This evaluation involved generation of data on a common set of ten substances in all methods and systematic collation of information including the level of standardisation, existing test data,potential for throughput, transferability and accessibility in cooperation with the test method developers.A workshop was held with the test method developers to review the outcome of this evaluation and to discuss the results. The evaluation informed the prioritisation of test methods for the next phase of the non-animal testing strategy development framework. Ultimately, the testing strategy – combined with bioavailability and skin metabolism data and exposure consideration – is envisaged to allow establishment of a data integration approach for skin sensitisation safety assessment of cosmetic ingredients.
authors.affiliation: Henkel AG & CO KGaA, Henkelstr. 67, 40191 Düsseldorf, Germany. kerstin.reisinger@henkel.com
authors.forename: Kerstin
authors.initials: K
authors.lastname: Reisinger
authors.forename: Sebastian
authors.initials: S
authors.lastname: Hoffmann
authors.forename: Nathalie
authors.initials: N
authors.lastname: Alépée
authors.forename: Takao
authors.initials: T
authors.lastname: Ashikaga
authors.forename: Joao
authors.initials: J
authors.lastname: Barroso
authors.forename: Cliff
authors.initials: C
authors.lastname: Elcombe
authors.forename: Nicola
authors.initials: N
authors.lastname: Gellatly
authors.forename: Valentina
authors.initials: V
authors.lastname: Galbiati
authors.forename: Susan
authors.initials: S
authors.lastname: Gibbs
authors.forename: Hervé
authors.initials: H
authors.lastname: Groux
authors.forename: Jalila
authors.initials: J
authors.lastname: Hibatallah
authors.forename: Donald
authors.initials: D
authors.lastname: Keller
authors.forename: Petra
authors.initials: P
authors.lastname: Kern
authors.forename: Martina
authors.initials: M
authors.lastname: Klaric
authors.forename: Susanne
authors.initials: S
authors.lastname: Kolle
authors.forename: Jochen
authors.initials: J
authors.lastname: Kuehnl
authors.forename: Nathalie
authors.initials: N
authors.lastname: Lambrechts
authors.forename: Malin
authors.initials: M
authors.lastname: Lindstedt
authors.forename: Marion
authors.initials: M
authors.lastname: Millet
authors.forename: Silvia
authors.initials: S
authors.lastname: Martinozzi-Teissier
authors.forename: Andreas
authors.initials: A
authors.lastname: Natsch
authors.forename: Dirk
authors.initials: D
authors.lastname: Petersohn
authors.forename: Ian
authors.initials: I
authors.lastname: Pike
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sakaguchi
authors.forename: Andreas
authors.initials: A
authors.lastname: Schepky
authors.forename: Magalie
authors.initials: M
authors.lastname: Tailhardat
authors.forename: Marie
authors.initials: M
authors.lastname: Templier
authors.forename: Erwin
authors.initials: E
authors.lastname: van Vliet
authors.forename: Gavin
authors.initials: G
authors.lastname: Maxwell
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D002460:Cell Line; D003358:Cosmetics; D017449:Dermatitis, Allergic Contact / Q000209:etiology*; D004817:Epidermis / Q000187:drug effects; D006801:Humans; D066298:In Vitro Techniques; D020382:Interleukin-18 / Q000032:analysis; D015603:Keratinocytes / Q000187:drug effects; D018570:Risk Assessment; D012867:Skin / Q000187:drug effects; D020298:U937 Cells / Q000187:drug effects
chemical_list: D003358:Cosmetics; D020382:Interleukin-18