EURL ECVAM Strategy for Replacement of Animal Testing for Skin Sensitisation Hazard Identification and Classification

Abstract

In the absence of validated and regulatory accepted alternative methods, the assessment of the skin sensitisation potential of chemicals still relies on animal testing. Progress in the development of alternative methods has been prompted by the increasing knowledge on the key mechanisms of the skin sensitisation pathway, as recently documented in the OECD Adverse Outcome Pathway for skin sensitisation. Based on an analysis of the regulatory requirements for this endpoint within relevant pieces of EU chemicals legislation, EURL ECVAM has decided to focus its efforts on the development of non-animal testing strategies for skin sensitisation hazard identification and classification, including the subcategorisation of sensitisers, according to the GHS classification system. This would satisfy the majority of the regulatory requirements within the EU and would have a significant impact in terms of replacing animal experiments. This report describes the EURL ECVAM strategy for achieving this goal. EUROPEAN COMMISSION Directorate General JRC JOINT RESEARCH CENTRE Institute for Health and Consumer Protection (Ispra) The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) EURL ECVAM Strategy for Replacement of Animal Testing for Skin Sensitisation Hazard Identification and Classification