EVALUATION OF THE BOVINE CORNEAL OPACITY PERMEABILITY ASSAY AS AN IN-VITRO ALTERNATIVE TO THE DRAIZE EYE IRRITATION TEST

The bovine corneal opacity-permeability assay (BCO-P) was evaluated as an in vitro alternative test model for the Draize eye irritancy test. Fifty pharmaceutical and commercially available compounds were tested in the BCO-P assay. The compounds were selected on the basis of their in vivo irritancy potential as determined in previous Draize tests. L iquids as well as solids were tested. Corneal opacity and permeability were measured to determine ocular irritation potential. When two irri tancy classifications (non-irritant and irritant) were considered, 96% of the tested chemicals were classified correctly. A 72% concordance was obtained when four irritancy classifications (non-irritant, mild, moderate and severe irritant) were considered. Furthermore, all compou nds that were severe eye irritants in vivo were equally scored in vitr o. The results of this study show that the BCO-P assay is a competent in vitro test system for the prediction of ocular irritation of chemic als. This test model can be used as a first screen to avoid in vivo te sting of severe ocular irritants.