EVALUATION OF EYE IRRITATION POTENTIAL - STATISTICAL-ANALYSIS AND TIER TESTING STRATEGIES

Eye irritation testing, specifically the Draize test, has been the cen tre of controversy for many reasons. Several alternatives, based on th e principles of reduction, refinement and replacement, have been propo sed and are being used by the industry and government authorities. How ever, no universally applicable, validated non-animal alternative(s) i s currently available. This report presents a statistical analysis and two testing approaches: the partial least squares multivariate statis tical analysis of de Silva and colleagues from France, the tier-testin g approach for regulatory purposes described by Gerner and colleagues from Germany, and the three-step tier-testing approach of the US Inter agency Regulatory Alternatives Group described by Gupta and Hill. Thes e approaches were presented as three separate papers at the November 1 993 Interagency Regulatory Alternatives Group (IRAG) Workshop on Eye I rritation Testing; they have been summarized and combined into the fol lowing three-part report. The first part (de Silva el al.) presents st atistical techniques for establishing test batteries of in vitro alter natives to the eye irritation test. The second (Gerner et nl.) and thi rd (Gupta and Hill) parts are similar in that they stage assessment of information by using a combination of screening information and anima l testing to effect reductions in animal use and distress. (C) 1997 El sevier Science Ltd.