Integrated Decision-tree Testing Strategies for Skin Corrosion and Irritation with Respect to the Requirements of the EU REACH Legislation

Summary — Liverpool John Moores University and FRAME recently conducted a research project, spon-sored by DEFRA, on the status of alternatives to animal testing with regard to the European Union REACH(Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessmentof chemicals. The project covered all the main toxicity endpoints associated with the REACH system. Thisreport focuses on how to maximise the use of alternative methods (both in vitro and in silico ) for skin cor-rosion and irritation testing within a tiered testing strategy. It considers the latest developments in in vitro testing, with particular reference to the reconstituted skin models which have now been now been suc-cessfully validated and independently endorsed as suitable for both skin corrosivity and irritancy testingwithin the EU. Key words: animal testing, decision-trees, Defra, in silico models, in vitro testing, integrated testingstrategies, REACH, risk assessment, skin corrosion, skin irritation, Three Rs.