| 引用本文: | 何立成,桑晶,谢珍,瞿霖吉,康桦,匡荣.化妆品毒理学试验方法的标准比对(Ⅱ)[J].中国现代应用药学,2023,40(16):2224-2230. |
| HE Licheng,SANG Jing,XIE Zhen,QU Linji,KANG Hua,KUANG Rong.Standard Comparison of Toxicological Test Methods for Cosmetics(II)[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(16):2224-2230. |
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| 摘要: |
| 《化妆品新原料注册备案资料管理规定》对化妆品新原料进行了分类管理，制订了系统、详实的新原料注册/备案资料清单。本文对此进行梳理，并比较了国内外急性经口毒性试验、亚慢性经口毒性试验和慢性毒性/致癌性结合试验标准，对现有的化妆品标准提出意见和建议。 |
| 关键词: 化妆品 急性经口毒性试验 亚慢性经口毒性试验 慢性毒性/致癌性结合试验 标准比对 |
| DOI：10.13748/j.cnki.issn1007-7693.20222389 |
| 分类号:R992 |
| 基金项目:浙江省药品监督管理局系统科技计划项目(2021024) |
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| Standard Comparison of Toxicological Test Methods for Cosmetics(II) |
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HE Licheng, SANG Jing, XIE Zhen, QU Linji, KANG Hua, KUANG Rong
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Zhejiang Institute for Food and Drug Control, NMPA Key Laboratory for Animal Alternative Testing Technology of Cosmetics, Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, Hangzhou 310052, China
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| Abstract: |
| “Measures for the Administration of the Registration and Recordation of Cosmetics” classified new cosmetic raw materials, setting a systematic and detailed request list for new raw materials registration and recordation. This paper sorted out the requirements and compared domestic and foreign standards for acute oral toxicity test, subchronic oral toxicity test and combined chronic toxicity/carcinogenicity test, providing comments and suggestions on current standards. |
| Key words: cosmetics acute oral toxicity test subchronic oral toxicity test combined chronic toxicity/carcinogenicity test standard comparison |
