ECVAM key area topical toxicity: Update on activities

The European Cosmetics Directive and REACH have accelerated the need for alternative tests. Especially the animal testing ban of cosmetic ingredients from 2009 strongly impacts on the timely delivery of relevant methods. ECVAM's key area "topical toxicity" focuses on skin and eye irritation/corrosion, phototoxicity and percutaneous absorption. Regulatory accepted alternative tests are available for skin corrosion, phototoxicity and percutaneous absorption. In the area of skin irritation, ECVAM recently finalised a study that demonstrates the scientific validity of a human reconstituted skin model to fully replace the animal test. In contrast, eye irritation testing will probably require an integrated testing strategy combining different in vitro assays that altogether might replace the animal test. To this end, ECVAM has contributed to the recent validation of organotypic models for detecting ocular corrosives and severe irritants. In parallel, four promising cytotoxicityand cell-functionbased assays are under evaluation by ECVAM. Finally, ECVAM is planning a prospective validation study on two human reconstituted tissue models. Moreover, the key area contributed to the implementation of the REACH legislation by leading the expert group on skin/eye irritation producing technical guidance for industry on toxicity testing under REACH.