P29. Inter-laboratory Validation of Alternative Methods to Eye Irritation Test for Safety Evaluation of Cosmetic Ingredients (4) Evaluation of Skin2(TM)ZK1100 and ZK1200 Models

Skin2(TM) ZK1100 and ZKl200 models are human dermal tissue cultures supplied by Advanced Tissue Sciences (ATS). These models were evaluated as alternatives to the Draize eye irritation test in rabbits. The thirty-nine chemicals used in this project. ZK1100 model testing was conducted according to the original kit protocol provided by ATS. ZK1200 model testing followed the Tissue Equivalent Assay (TEA) protocol developed by Procter & Gamble. The endpoints of these methods were determined as 50010 cell viability in a MTT assay. ZK1100 model results showed an average coefficient of variation (C.V.) of 0.117-1.328. Pearson's correlation with maximum average score (MAS) from the Draize tests was r=-0.70. ZK1200 model results showed an average C.V. of 0.318-1.192, and Pearson's colcelation with the Draize MAS values was r=-0.63. When a score of fifteen on the Draize scale (0.110) was set as the breakpoint for classification of eye irritancy on Cooper's plots comparing the in vitro and Draize data, the ZK1100 model results showed five false positives and four false negatives; the ZK1200 model results showed four false positives and no false negatives. These studies were partly supported by a Research Grant for Health Sciences, MHW.