title: Alternatives for skin sensitisation: Hazard identification and potency categorisation: Report from an EPAA/CEFIC LRI/Cosmetics Europe cross sector workshop, ECHA Helsinki, April 23rd and 24th 2015.
abstract: In the two years since the last workshop report, the environment surrounding the prediction of skin sensitisation hazards has experienced major change. Validated non-animal tests are now OECD Test Guidelines. Accordingly, the recent cross sector workshop focused on how to use in vitro data for regulatory decision-making. After a review of general approaches and six case studies, there was broad consensus that a simple, transparent stepwise process involving non-animal methods was an opportunity waiting to be seized. There was also strong feeling the approach should not be so rigidly defined that assay variations/additional tests are locked out. Neither should it preclude more complex integrated approaches being used for other purposes, e.g. potency estimation. All agreed the ultimate goal is a high level of protection of human health. Thus, experience in the population will be the final arbiter of whether toxicological predictions are fit for purpose. Central to this is the reflection that none of the existing animal assays is perfect; the non-animal methods should not be expected to be so either, but by integrated use of methods and all other relevant information, including clinical feedback, we have the opportunity to continue to improve toxicology whilst avoiding animal use.
authors.affiliation: DABMEB Consultancy Ltd, Sharnbrook, MK44 1PR, UK. Electronic address: dabmebconsultancyltd@me.com.
authors.forename: David
authors.initials: D
authors.lastname: Basketter
authors.affiliation: Shiseido, Yokohama, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Ashikaga
authors.affiliation: EURL ECVAM, Ispra, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Casati
authors.affiliation: CEFIC, Brussels, Belgium; Hubesch Consult BVBA, Sint-Pieters-Leeuw, Belgium.
authors.forename: Bruno
authors.initials: B
authors.lastname: Hubesch
authors.affiliation: Procter & Gamble, Belgium.
authors.forename: Joanna
authors.initials: J
authors.lastname: Jaworska
authors.affiliation: OECD, Paris, France.
authors.forename: Joop
authors.initials: J
authors.lastname: de Knecht
authors.affiliation: BASF SE, Ludwigshafen, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Landsiedel
authors.affiliation: EPAA, Brussels, Belgium.
authors.forename: Irene
authors.initials: I
authors.lastname: Manou
authors.affiliation: BASF Personal Care and Nutrition GmbH, Duesseldorf, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Mehling
authors.affiliation: Henkel AG & Co. KGaA, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Petersohn
authors.affiliation: RIVM, Bilthoven, The Netherlands.
authors.forename: Emiel
authors.initials: E
authors.lastname: Rorije
authors.affiliation: ECHA, Helsinki, Finland.
authors.forename: Laura H
authors.initials: LH
authors.lastname: Rossi
authors.affiliation: VCI, (Verband der Chemischen Industrie e.V.), Frankfurt/Main, Germany.
authors.forename: Winfried
authors.initials: W
authors.lastname: Steiling
authors.affiliation: L'Oreal, Paris, France.
authors.forename: Silvia
authors.initials: S
authors.lastname: Teissier
authors.affiliation: EURL ECVAM, Ispra, Italy.
authors.forename: Andrew
authors.initials: A
authors.lastname: Worth
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods* / Q000639:trends; D000818:Animals; D003358:Cosmetics / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000633:toxicity*; D017449:Dermatitis, Allergic Contact / Q000378:metabolism / Q000473:pathology; D004493:Education / Q000379:methods* / Q000639:trends; D005060:Europe; D005387:Finland; D006801:Humans; D058028:Research Report / Q000639:trends; D018570:Risk Assessment / Q000379:methods / Q000639:trends; D012867:Skin / Q000187:drug effects* / Q000378:metabolism / Q000473:pathology
chemical_list: D003358:Cosmetics
keywords: Integrated approaches to testing and assessment; Integrated testing strategies; In vitro alternatives; Skin sensitisation; hazard classification