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首页> 外文期刊>The Journal of toxicological sciences >Comparative assessment of 24-hr primary skin irritation test and human patch test data with in vitro skin irritation tests according to OECD Test Guideline 439 (for quasi-drugs in Japan)
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Comparative assessment of 24-hr primary skin irritation test and human patch test data with in vitro skin irritation tests according to OECD Test Guideline 439 (for quasi-drugs in Japan)

机译：根据经合组织试验指南439（日本对准药物的体外皮肤刺激试验，对24小时原发性皮肤刺激试验和人贴剂测试数据的比较评估

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摘要

The Organisation for Economic Co-operation and Development (OECD) Test Guideline (TG) 439 is an in vitro test method of reconstructed human epidermis (RhE), which was developed for hazard identification of irritating chemicals in accordance with a primary skin irritation test using rabbits with 4-hr exposure. A regulation for quasi-drugs in Japan requires data from primary skin irritation tests using rabbits to undergo 24-hr exposure, and this is used as an evidence for 24-hr closed patch tests in humans. In this study with the same chemicals, primary skin irritation test data using rabbits undergoing 24-hr exposure and a 24-hr occlusive human patch test data were analyzed by comparing the results obtained with four test methods adopted in OECD TG 439. The performances of in vitro test methods showed a positive predictive value of 72.7-85.7% to predict the results of 24-hr primary rabbit skin irritation test knowing that its positive predictive value was 57.1% against humans only. The prediction factors of in vitro test methods were higher for the human patch test data with a sensitivity reaching 60 to 80%. Three surfactants gave false negatives in some of the RhE methods evaluated with the human patch test, but in each case, they were correctly classified as positive when evaluated at double concentration. Therefore, the approach of setting the margin to 2 was effective in eliminating false negatives. This suggests that in vitro test methods are useful for assessing skin irritation potential without animal testing for the application of quasi-drugs in Japan.
机译：经济合作和开发组织（经合组织）试验指南（TG）439是重建人表皮（RHE）的体外试验方法，该方法是根据主要皮肤刺激试验的刺激性化学品的危害鉴定而开发的兔子有4小时曝光。对日本的准药物调节要求使用兔子进行24小时暴露的原发性皮肤刺激试验数据，这被用作人类中24小时封闭贴片测试的证据。在本研究中，通过比较OECD TG 439采用的四种试验方法获得的结果，通过比较了24-HR暴露的兔的原发性皮肤刺激试验数据和24小时闭塞式人贴剂测试数据。体外试验方法显示出阳性预测值72.7-85.7％，以预测24-HR初级兔皮肤刺激测试的结果，知道其阳性预测值仅为人类的阳性预测值为57.1％。人贴剂测试数据的预测因素较高，灵敏度达到60％至80％。三种表面活性剂在用人贴剂测试中评估的一些RHE方法中给出了假阴性，但在每种情况下，当以双浓度评估时，它们被正确归类为正阳性。因此，将边距到2的方法有效地消除了错误的底片。这表明体外试验方法可用于评估皮肤刺激潜力而没有动物检测，用于在日本应用准药物。

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    Sugiyama Mariko; Akita Masaharu; Alepee Nathalie; Fujishiro Miyuki; Hagino Shigenobu; Handa Yuki; Ikeda Hidefumi; Imai Noriyasu; Jitsukawa Setsuko; Katoh Masakazu; Kurihara Koji; Kyotani Daiki; Nomura Shigeyuki; Okamoto Yuko; Okumura Hidenobu; Omori Takashi; Sugibayashi Kenji; Todo Hiroaki; Toyoda Akemi; Ohno Yasuo;

  • 作者单位

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    LOreal Res &

    Innovat 1 Ave Eugene Schueller F-93601 Aulnay Sous Bois France;

    Cosmos Tech Ctr Co Ltd Itabashi Ku 3-24-3 Hasune Tokyo 1740046 Japan;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    Kurabo Ind Ltd 14-5 Shimokida Cho Neyagawa Osaka 5720823 Japan;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    LOreal Res &

    Innovat Takatsu Ku 2-1 Sakado 3 Chome Kawasaki Kanagawa 2130012 Japan;

    Japan Tissue Engn Co Ltd 6-209-1 Miyakitadori Gamagori Aichi 4430022 Japan;

    Nikoderm Res Inc Chuo Ku 1-6-14 Azuchimachi Osaka Osaka 5410052 Japan;

    Nikoderm Res Inc Chuo Ku 1-6-14 Azuchimachi Osaka Osaka 5410052 Japan;

    KOSE Corp Ltd Itabashi Ku 1-18-4 Azusawa Tokyo 1740051 Japan;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

    JSAAE Working Grp Alternat Primary Skin Irritat Test Bunkyo Ku 5-3-13 Otsuka Tokyo 1120012;

  • 收录信息
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 药学;
  • 关键词

    Skin irritation; 24-hr Human patch test; Reconstructed human epidermis; OECD TG 439; In vitro; Quasi-drugs;

    机译：皮肤刺激;24小时人贴剂试验;重建人表皮;经合组织TG 439;体外;准药物;

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