title: Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (5) Skin(2TM) ZK1100 and tissue equivalent assay.
abstract: Skin(2TM) ZK1100 (ZK1100) assay and tissue equivalent assay (TEA, Skin(2TM) ZK1200) are human dermal models. These assays were evaluated as alternatives to the Draize eye irritation test (Draize test) in rabbits. Thirty-nine cosmetic ingredients were selected and used as test substances. The ZK1100 assay was conducted according to an original protocol provided by Advanced Tissue Sciences, a kit supplier. The TEA assay followed a protocol developed by Osborne et al., (1995a). Coefficients of variation (CV) ranged from 11.7 to 133 in results from the ZK1100 assay; three test substances showed the CVs more than 100. These were cetyltrimethylammonium chloride (S3-7), domiphen bromide (S3-11) and di(2-ethylhexyl) sodium sulfosuccinate (S3-14). Acid Red 92 (S2-3) was excluded from data analysis because its absorbance interfered with the endpoint of ZK1100 assay. The CVs from the TEA assay ranged from 31.8 to 119; two test substances showed the CVs more than 100. These were acetic acid and glycolic acid (S3-13). Butanol (S3-9) was excluded from the analysis because it was assumed to volatilize during a sample preparation. Pearson's coefficient of correlation with maximum average Draize total score (MAS) and 24hr score from the Draize tests were -0.71 and -0.72 for the ZK1100 results and -0.63 and -0.60 for the TEA results. When a MAS of 15 was set as a breakpoint for the classification of eye irritancy on Cooper's plots comparing the in vitro and the Draize data, the ZK1100 results showed five false positives and four false negatives; the TEA results showed three false positives and no false negatives.
authors.affiliation: Japan Cosmetic Industry Association, Hatsumei Bldg, 9-14, Toranomon 2-chome, Minato-ku, Tokyo 105Japan; Professional & Regulatory Services/Regulatory & Clinical Development, Kobe Technical Center, Procter & Gamble Far East Inc., 1-17, Koyo-cho Naka, Higashinada-ku, Kobe 658Japan.
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