EVALUATION OF THE EPIOCULAR(TM) TISSUE MODEL AS AN ALTERNATIVE TO THEDRAIZE EYE IRRITATION TEST

Cosmetic ingredients were tested to determine the ability of the EpiOc ular(TM) tissue model to predict eye irritation potential. In vitro re sults were compared with historical Draize eye irritation records. For ty-three samples, consisting of 40 cosmetic raw ingredients of differe nt type and physical form (i.e. liquids, powders, gels) were evaluated . Using the MTT cytotoxicity assay, an ET50 value (effective time of e xposure to reduce tissue viability to 50%) was determined for each sam ple. ET50 values were categorized into four irritation groups: (a) non -irritating/minimal; (b) mild; (c) moderate; or (d) severe/extreme. Co mparison of in vitro EpiOcular(TM) and in vivo Draize classifications showed that 63% (27 of 43 samples) were classified identically. Assay performance improved to 95% (41 of 43 samples) with the addition of sa mples overpredicted by a single irritation class. This evaluative exer cise represents a conservative safety assessment. There were no underp redictions of eye irritation for any material in this study. Based on these results, use of the EpiOcular(TM) tissue model shows promise as an in vitro assay to assess the ocular irritation potential of cosmeti c ingredients. 1998 Elsevier Science Ltd. All rights reserved.