EUROPEAN COMMISSION DIRECTORATE GENERAL JRC JOINT RESEARCH CENTRE Institute for Health and Consumer Protection European Centre for the Validation of Alternative Methods (ECVAM) STATEMENT ON THE VALIDITY OF IN-VITRO TESTS FOR SKIN IRRITATION

of these, the EPISKIN method showed evidence of being a reliable and relevant standalone test for predicting rabbit skin irritation, when the endpoint is evaluated by MTT reduction, and for being used as a replacement (based on the performance of the assay as specified in the annex) for the Draize Skin Irritation Test (OECD TG 404 & Method B.4 of Annex V to Directive 67/548/EEC) for the purposes of distinguishing between R38 skin irritating and no-label (non-skin irritating) test substances. At the present time, the IL-1α endpoint should be regarded as a useful adjunct to the MTT assay, as it has the potential to increase the sensitivity of the test, without reducing its specificity. This endpoint could be used to confirm negatives obtained with the MTT endpoint.