NON-ANIMAL METHODS FOR TOXICITY TESTING: THE WAY FORWARD FOR IN VITRO SKIN IRRITATION TESTING.

A major milestone for in vitro skin irritation testing was achieved with the recent release of the Statement on the Validity of In-Vitro Tests for Skin Irritation by the European Centre for the Validation of Alternative Methods (ECVAM) Scientific Advisory Committee (ESAC). The statement endorsed the use of in vitro skin models and the MTT endpoint as a replacement for the in vivo Draize (rabbit) Skin Irritation Test (OECD TG 404 & Method B.4 of Annex V to Directive 67/548/EEC) for the purpose of distinguishing between R38 (skin irritating) and no-label (non-irritating) chemicals. Thanks and congratulations are in order to all of the many dedicated individuals involved in the long and difficult efforts to make this day a reality, particularly those who served on the validation study Management Team, independent experts of the Peer Review Panel, the sponsoring organization ECVAM/Joint Research Centre, as well as the testing laboratories.