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China Surfactant Detergent & Cosmetics ›› 2021, Vol. 51 ›› Issue (8): 768-774.doi: 10.3969/j.issn.1001-1803.2021.08.011

• Development and application • Previous Articles     Next Articles

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 E-mail:wangping662@sina.com;wangxiaowei@szidc.org.cn

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

CLC Number: 

  • TQ658