纳米氧化锌安全性评价及化妆品法规管理现状

On Current Status of Zinc Oxide Nanoparticles' Safety Evaluation and Cosmetic Regulation

目的:了解国内外纳米氧化锌安全性评价及化妆品法规管理现状,为我国对纳米原料与纳米化妆品监管提供参考。方法:通过文献研究,总结目前国内外纳米氧化锌的毒理学研究进展及世界主要国家及地区对纳米氧化锌的化妆品法规管理现状。结果:透皮吸收试验发现防晒霜中的纳米氧化锌主要聚集在人体皮肤角质层和毛囊皮脂腺开口处,微量锌可经皮肤吸收进入血液,但不能确定是以氧化锌还是锌离子的形式吸收。体外彗星试验结果显示纳米氧化锌引起人表皮细胞、人鼻粘膜细胞DNA损伤。亚急性经口毒性试验发现纳米氧化锌通过氧化应激介导小鼠肝脏细胞DNA损伤和凋亡。纳米氧化锌对小鼠具有生殖发育毒性。急性吸入毒性试验显示纳米氧化锌导致大鼠肺脏、肝脏组织损伤。亚慢性毒性试验显示纳米氧化锌高剂量组(536.8 mg·kg^(-1))SD大鼠出现贫血及轻度到中度胰腺炎,纳米氧化锌的未观察到有害作用水平(NOAEL)为268.4 mg·kg^(-1)。欧盟、美国、中国台湾已出台了一系列化妆品纳米材料的法规或文件,指导化妆品行业开展纳米材料的安全性评价。结论:化妆品中纳米氧化锌对人体具有潜在安全风险,我国应尽快制定化妆品中纳米原料的相关管理政策。

Objective： To study on the current status of zinc oxide nanoparticles＇ safety evaluation and cosmetic regulation in order to provide references for the regulation of nano-materials and nano-cosmetics in China. Methods： The research progress of toxicologic study and current status of the regulation of zinc oxide nanoparticles in major countries and regions in the world were summarized through literature review. Results： Related data demonstrated that most of zinc oxide nanoparticles contained in sunscreen creams were left in the human stratum corneum and in the opening of the sebaceous gland of hair follicle. Trace zinc could be absorbed into the blood through the skin, but it cannot be determined whether it was absorbed in the form of zinc oxide or zinc ion. In vitro comet assay results showed that zinc oxide nanoparticles caused DNA damage to human epidermal cells and human nasal mucosal cells. Subacute oral toxicity test found out that zinc oxide nanoparticles could induce DNA damage and apoptosis in mouse＇s liver cells through oxidative stress. Zinc oxide nanoparticles had reproductive and developmental toxicity for mice. Acute inhalation toxicity tests showed that Zinc oxide nanoparticles caused lung and liver tissue damage to rats. Subchronic toxicity test showed that anemia and mild to moderate pancreatitis were observed in SD rats who were exposed to zinc oxide nanoparticles at high doses（536.8 mg·kg^（-1））. The NOAEL of nano-Zn O was 268.4 mg·kg^（-1）. The European Union, the United States, and Taiwan of China have issued a series of regulations or documents on cosmetic nanomaterials to guide the safety evaluation of the nano-material in cosmetics. Conclusion： The zinc oxide nanoparticles in cosmetics have potential safety risks to the human body. Regulatory policies for nano-material in cosmetics should be formulated as soon as possible in China.