Ocular Toxicity

The assessment of ocular toxicity, (i.e., eye irritation and serious eye damage) is important to ensure the safety of products and their components used in our daily life. In several EU legislations related to chemicals and products, the generation of information on eye irritation and serious eye damage represents a standard requirement. The traditional eye irritation test, also known as the Draize eye test. is performed on albino rabbits. Ethical and scientific considerations as well as legal requirements in EU legislations have triggered the development and validation of alternative methods to the Draize test. Since no in vitro test taken individually can nowadays fully replace the Draize eye test, testing schemes combining strengths of particular in vitro assays were proposed The conceptual framework of testing strategies based on a Bottom-Up or Top-Down approach, are described in this chapter. In addition, a summary of the most promising in vitro test methods as well as their validation and regulatory acceptance status is given. Finally some strategic proposals on the way forward in this area are made.JRC.I.5-Systems Toxicolog