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日用化学工业 ›› 2021, Vol. 51 ›› Issue (8): 768-774.doi: 10.3969/j.issn.1001-1803.2021.08.011

• 开发与应用 • 上一篇    下一篇

化妆品中硝基甲烷的风险评估和使用监管探索

秦美蓉,冼静雯,吴熙,张高飞,邬晓鸥,王平(),王晓炜()   

  1. 深圳市药品检验研究院 国家药品监督管理局化妆品监测评价重点实验室,广东 深圳 518057
  • 收稿日期:2020-10-29 修回日期:2021-08-06 出版日期:2021-08-22 发布日期:2021-08-24
  • 通讯作者: 王平,王晓炜

Study on risk assessment and use regulation of nitromethane in cosmetics

Qin Meirong,Xian Jingwen,Wu Xi,Zhang Gaofei,Wu Xiaoou,Wang Ping(),Wang Xiaowei()   

  1. Shenzhen Institute for Drug Control, NMPA Key Laboratory of Cosmetics Monitoring and Evaluation, Guangdong, Shenzhen 518057, China
  • Received:2020-10-29 Revised:2021-08-06 Online:2021-08-22 Published:2021-08-24
  • Contact: Ping Wang,Xiaowei Wang

摘要:

世界卫生组织国际癌症研究中心将硝基甲烷归为2B类致癌物,各国相关机构及组织对其进行了安全评估,并对其使用进行了限制。文章根据目前的毒理研究结果对硝基甲烷开展风险评估,并对比分析各国法规中关于硝基甲烷使用的规定,对化妆品中硝基甲烷的使用安全进行风险评估,为其监管要求提出建议。结果发现化妆品中硝基甲烷含量限值为0.3%(w/w)时MoE<1,致癌性风险应予以关注。由于目前在中国境内销售的化妆品中尚未查询到标识含有硝基甲烷的产品,境外个别品种含有硝基甲烷也并非作为化妆品原料添加,建议将硝基甲烷列入化妆品禁用物质名单。

关键词: 硝基甲烷, 风险评估, 化妆品原料, 监管

Abstract:

Nitromethane has been classified by the International Agency for Research on Cancer (IARC, 2000) as a Group 2B carcinogen. There is sufficient evidence in experimental animals for the carcinogenicity of nitromethane. Relevant institutions and organizations have evaluated its safety and restricted its use all over the world. In the European Union and Malaysia, nitromethane is allowed in cosmetic products at a maximum concentration of 0.3%, and South Korea bans the use of nitromethane in cosmetics. In addition, China, United States and Japan all regulate the residue limit of nitromethane in drugs. Our key laboratory assessed the safety of its use in cosmetics, and aimed to provide advice and suggestion for cosmetics supervision. Via dermal absorption and inhalation are the main routes of exposure to nitromethane from products. Based on the current toxicological research data, we conducted the risk assessment of nitromethane in various cosmetic products such as mascara, eyeliner, body lotion and hair spray, and made comparative analysis of use regulations in various countries. The results show that the MoE value of nitromethane is less than 1 when the limit of it in cosmetics is 0.3%(w/w), so the carcinogenic risk of nitromethane should be concerned. Due to no cosmetics sold in China have been identified containing nitromethane at present, and individual cosmetic products containing nitromethane overseas are not added as cosmetic raw materials. It is recommended to include nitromethane in the list of prohibited substances in cosmetics.

Key words: nitromethane, risk assessment, cosmetics materials, use regulation

中图分类号: 

  • TQ658