A step-by-step approach for assessing acute oral toxicity without animal testing for additives of quasi-drugs and cosmetic ingredients

IF 2.9 Q2 TOXICOLOGY

Current Research in Toxicology Pub Date : 2023-01-01 DOI:10.1016/j.crtox.2022.100100

Hajime Kojima , Tokio Nakada , Akiko Yagami , Hiroaki Todo , Jihei Nishimura , Mio Yagi , Keiko Yamamoto , Mariko Sugiyama , Yoshiaki Ikarashi , Hitoshi Sakaguchi , Masahiko Yamaguchi , Morihiko Hirota , Sakiko Aizawa , Shota Nakagawa , Shigenobu Hagino , Masato Hatao

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引用次数: 2

Abstract

Animal testing of cosmetic ingredients and products has been banned in the European Union since 2013. However, in Japan, the application of new quasi-drugs requires the generation of data on acute oral toxicity through animal testing. A weight of evidence approach for assessing oral toxicity was challenged. This approach used a combination of safety data, including a neutral red uptake cytotoxicity assay using BALB/c3T3 cells (3T3-NRU cytotoxicity assay), which can assess the acute oral toxicity of quasi-drugs or cosmetic ingredients. We conclude that the step-by-step approach can be used to assess test substances that cause low acute oral toxicity, such as the median lethal dose (LD 50) > 2000 mg/kg, thereby avoiding animal testing.

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一种逐步评估急性口服毒性的方法，无需对准药物和化妆品成分的添加剂进行动物试验

自2013年以来，欧盟禁止对化妆品成分和产品进行动物试验。然而，在日本，新的准药物的应用需要通过动物试验产生急性口服毒性的数据。评估口服毒性的证据权重方法受到质疑。该方法使用了安全性数据的组合，包括使用BALB/c3T3细胞的中性红摄取细胞毒性测定（3T3-NRU细胞毒性测定），该测定可以评估准药物或化妆品成分的急性口服毒性。我们得出的结论是，逐步方法可用于评估引起低急性口服毒性的测试物质，例如中位致死剂量（LD 50）>；2000 mg/kg，从而避免了动物试验。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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