THE EC HO INTERNATIONAL VALIDATION-STUDY ON ALTERNATIVES TO THE DRAIZE EYE IRRITATION TEST/

This is the final report of the Management Team for a European Commiss ion/British Home Office (EC/HO) validation study on alternatives to th e Draize eye irritation test. The principal goal of the study was to e stablish whether one or more of nine non-animal tests could be used to replace the Draize test for all severely irritating materials (or tho se belonging to specific classes) or the animal test completely for ch emicals with or without regard to chemical class. Sixty chemicals were independently selected, coded and supplied, then the data obtained in 37 laboratories were analysed independently. The results of compariso ns between 27 alternative test index scores and the Modified Maximum A verage Scores (MMASs) obtained in the Draize eye test were compared. T ables of results showing Pearson's product moment correlation coeffici ents and Spearman's rank coefficients for each laboratory are provided , and correlation matrices of alternative test index scores among the different groups of laboratories are shown for each endpoint. Scatterp lots are provided, in which the alternative test scores obtained by th e lead laboratories for the nine tests are plotted against the MMAS fo r the full set of chemicals and 12 surfactants. It is concluded that, with the possible exception of predicting the irritancy of surfactants , none of the nine tests met any of the four performance targets. Poss ible reasons for this outcome are discussed.