title: Skin sensitisation--moving forward with non-animal testing strategies for regulatory purposes in the EU.
abstract: In a previous EPAA-Cefic LRI workshop in 2011, issues surrounding the use and interpretation of results from the local lymph node assay were addressed. At the beginning of 2013 a second joint workshop focused greater attention on the opportunities to make use of non-animal test data, not least since a number of in vitro assays have progressed to an advanced position in terms of their formal validation. It is already recognised that information produced from non-animal assays can be used in regulatory decision-making, notably in terms of classifying a substance as a skin sensitiser. The evolution into a full replacement for hazard identification, where the decision is not to classify, requires the generation of confidence in the in vitro alternative, e.g. via formal validation, the existence of peer reviewed publications and the knowledge that the assay(s) are founded on key elements of the Adverse Outcome Pathway for skin sensitisation. It is foreseen that the validated in vitro assays and relevant QSAR models can be organised into formal testing strategies to be applied for regulatory purposes by the industry. To facilitate progress, the European Partnership for Alternative Approaches to animal testing (EPAA) provided the platform for cross-industry and regulatory dialogue, enabling an essential and open debate on the acceptability of an in vitro based integrated strategy. Based on these considerations, a follow up activity was agreed upon to explore an example of an Integrated Testing Strategy for skin sensitisation hazard identification purposes in the context of REACH submissions.
authors.affiliation: DABMEB Consultancy Ltd., Sharnbrook MK44 1PR, UK. Electronic address: dabmebconsultancyltd@me.com.
authors.forename: David
authors.initials: D
authors.lastname: Basketter
authors.forename: Nathalie
authors.initials: N
authors.lastname: Alépée
authors.forename: Silvia
authors.initials: S
authors.lastname: Casati
authors.forename: Jonathan
authors.initials: J
authors.lastname: Crozier
authors.forename: Dorothea
authors.initials: D
authors.lastname: Eigler
authors.forename: Peter
authors.initials: P
authors.lastname: Griem
authors.forename: Bruno
authors.initials: B
authors.lastname: Hubesch
authors.forename: Joop
authors.initials: J
authors.lastname: de Knecht
authors.forename: Robert
authors.initials: R
authors.lastname: Landsiedel
authors.forename: Kimmo
authors.initials: K
authors.lastname: Louekari
authors.forename: Irene
authors.initials: I
authors.lastname: Manou
authors.forename: Gavin
authors.initials: G
authors.lastname: Maxwell
authors.forename: Annette
authors.initials: A
authors.lastname: Mehling
authors.forename: Tatiana
authors.initials: T
authors.lastname: Netzeva
authors.forename: Thomas
authors.initials: T
authors.lastname: Petry
authors.forename: Laura H
authors.initials: LH
authors.lastname: Rossi
mesh_terms: D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends; D000818:Animals; D003226:Congresses as Topic; D017449:Dermatitis, Allergic Contact / Q000209:etiology*; D005062:European Union; D033161:Government Regulation; D015386:Hazardous Substances / Q000737:chemistry / Q000633:toxicity*; D006801:Humans; D007391:International Cooperation; D012867:Skin / Q000187:drug effects*
chemical_list: D015386:Hazardous Substances
keywords: Hazard characterisation; Hazard classification; In vitro alternatives; Skin sensitisation