化妆品成分体外眼刺激试验的实验室间验证。(5) 皮肤(2TM) ZK1100和组织等效性试验。

Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (5) Skin(2TM) ZK1100 and tissue equivalent assay.

作者信息

Kurishita A, Katoh T, Ohsawa H, Nakasawa H, Sugiura H, Usami M, Kakishima H, Kuwahara H, Ohuchi J, Kasai Y, Ohokoshi K, Okamoto Y, Morito Y, Shibata M, Tsuda T, Kojima H, Mizutani A, Ikeda N, Sumida Y, Nishifuji M, Katagiri M, Kazama A, Hayashi N, Hirose A, Kaneko T, Ohno Y

机构信息

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.

出版信息

Toxicol In Vitro. 1999 Feb;13(1):139-51. doi: 10.1016/s0887-2333(98)00068-x.

DOI:10.1016/s0887-2333(98)00068-x

PMID:20654472

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.

摘要

皮肤（2TM）ZK1100试验和组织等效性试验（TEA，皮肤（2TM）ZK1200）是人体皮肤模型。这些试验被评估为兔眼Draize刺激性试验（Draize试验）的替代方法。选择了39种化妆品成分作为受试物质。ZK1100试验按照试剂盒供应商Advanced Tissue Sciences提供的原始方案进行。TEA试验遵循Osborne等人（1995年a）制定的方案。ZK1100试验结果的变异系数（CV）范围为11.7至133；三种受试物质的CV超过100。这些物质是十六烷基三甲基氯化铵（S3-7）、度米芬溴化物（S3-11）和二（2-乙基己基）磺基琥珀酸钠（S3-14）。酸性红92（S2-3）被排除在数据分析之外，因为其吸光度干扰了ZK1100试验的终点。TEA试验的CV范围为31.8至119；两种受试物质的CV超过100。这些物质是乙酸和乙醇酸（S3-13）。丁醇（S3-9）被排除在分析之外，因为假定其在样品制备过程中挥发。ZK1100试验结果与Draize试验的最大平均总评分（MAS）和24小时评分的Pearson相关系数分别为-0.71和-0.72，TEA试验结果的相关系数分别为-0.63和-0.60。在比较体外试验和Draize试验数据的Cooper图上，当将MAS为15设定为眼刺激性分类的断点时，ZK1100试验结果显示5例假阳性和4例假阴性；TEA试验结果显示3例假阳性且无假阴性。