人细胞系活化试验用于皮肤致敏性测试的实验验证

袁园; 阳晓燕; 石莹; 阮鸿洁; 宋瑞霞; 张宏伟

doi:10.13421/j.cnki.hjwsxzz.2019.01.011

人细胞系活化试验用于皮肤致敏性测试的实验验证

Experimental Verification of Human Cell Line Activation Test for Skin Allergenicity Detection

摘要

摘要:
目的在实验室建立皮肤致敏的体外检测。
方法人细胞系活化试验（human Cell Line Activation Test，h-CLAT），并对染料前体、染发剂成品的皮肤致敏性进行检测。
方法参考OECD 442（E）标准方法，用OECD 442（E）附表 2推荐的10种验证物质建立方法，确定实验可靠性，对4种样品进行皮肤致敏性检测。分别使用CCK-8法和流式细胞术检测10种验证物质的细胞毒性并进行比较。
结果 10种验证物质检测结果符合OECD 442（E）要求，4种样品的h-CLAT检测结果和LLNA方法结果一致。CCK-8法和流式细胞术检测细胞毒性结果均符合OECD参考范围，两种方法的组内相关系数（Intra-group Correlation Coefficient，ICC）为0.993。
结论在实验室内建立了可靠的h-CLAT检测方法，并且可以应用于部分染发类产品的致敏性检测。

Abstract:
Objectives To establish the human cell line activation test (h-CLAT) in laboratory to detect skin allergenicity of dye precursors and hair dye products.
Methods To establish the method and determine the reliability of the experiment by using 10 proficiency substances recommended in ANNEX Ⅱ of OECD 442(E). Four samples were tested for skin allergenicity. The cytotoxicities of the 10 proficiency substances were measured by CCK-8 method and flow cytometry method respectively, and comparisons were further conducted.
Results The result of 10 proficiency substances were in accordance with OECD 442(E) requirements. Four samples' skin allergenicity result of h-CLAT were consistent with those of the LLNA method. The cytotoxicity result of CCK-8 and flow cytometry were both in accordance with the OECD reference range. The intra-group correlation coefficient (ICC) between the two method was 0.993.
Conclusions A reliable h-CLAT test method has been established in the laboratory and can be applied to the allergenicity detection of some hair dye products.

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