Use of In Vitro Data and (Q)SARs to Classify Eye Irritating Chemicals in the EU – Experience at the BfR

Today, the Draize rabbit eye test, which was introduced over sixty years ago (Draize et al., 1944), still forms the basis of internationally agreed protocols for eye irritation/corrosion testing (European Commission, 2004; OECD, 2002). The success of this test is based on its obvious biological relevance and the fact that multiple aspects of ocular irritation/corrosion, i.e. different target sites within the eye, as well as the level of severity and the reversibility of effects, are covered in a single test. However, the Draize test has also been subject to criticism, not only because of the pain and suffering caused to the animals, but also on scientific grounds, among others because of the great variability and low reproducibility of results, an allegedly unrealistic application procedure, and because of differences in the anatomy, physiology, and biochemistry of the rabbit vs. the human eye (Spielmann, 1997; York and Steiling, 1998). Strategies for classification and labelling