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

摘要: In the two years since last workshop report, environment surrounding prediction of skin sensitisation hazards has experienced major change. Validated non-animal tests are now OECD Test Guidelines. Accordingly, recent cross sector focused on how to use in vitro data for regulatory decision-making. After a review general approaches and six case studies, there was broad consensus that simple, transparent stepwise process involving methods an opportunity waiting be seized. There also strong feeling approach should not so rigidly defined assay variations/additional locked out. Neither it preclude more complex integrated being used other purposes, e.g. potency estimation. All agreed ultimate goal is high level protection human health. Thus, experience population will final arbiter whether toxicological predictions fit purpose. Central this reflection none existing animal assays perfect; expected either, but by all relevant information, including clinical feedback, we have continue improve toxicology whilst avoiding use.