二羟丙酮安全性评价及化妆品法规管理现状

Current Status of the Safety Evaluation and Cosmetic Regulations on Dihydroxyacetone

目的:对二羟丙酮的安全性评价和主要国家(地区)关于二羟丙酮在化妆品中使用的相关监管法规进行调查研究,为我国对化妆品中二羟丙酮的监管提供参考依据。方法:通过文献研究,总结目前国内外二羟丙酮的安全性评价研究进展和全球对二羟丙酮的化妆品管理法规现状。结果:二羟丙酮的急性毒性较低,对新西兰白兔的皮肤/眼睛无刺激性;含10%二羟丙酮化妆品配方中的二羟丙酮经皮吸收率为37.2%(84.4μg·cm^-2);90天大鼠经口毒性和生殖毒性试验的未观察到作用剂量(NOEL)均为1000 mg/(kg·d^-1);二羟丙酮导致人永生化角质形成细胞(HaCaT)和人黑色素瘤细胞(A375P)凋亡;无论有无代谢转化系统(S9),二羟丙酮对组氨酸缺陷型鼠伤寒沙门氏菌株TA100和TA102有致突变作用;且对人体具有致敏作用。欧盟对化妆品中的二羟丙酮的安全性评价结论为涂抹类产品中含10%以下、喷雾类产品中含14%以下的二羟丙酮是安全的,美国和韩国将二羟丙酮列入着色剂清单进行严格管理。结论:化妆品中二羟丙酮对人体具有潜在安全风险,应高度关注并开展化妆品中二羟丙酮的风险监测和风险评估工作。

Objective: To study the safety evaluation of dihydroxyacetone(DHA) and the relevant national and regional regulations on the use of DHA in cosmetics in order to provide references for the regulation of DHA in cosmetics in China. Methods: The research progress in safety evaluation and the current status of the global cosmetic regulations of DHA were summarized through literature review. Results: DHA had low acute toxicity and was neither a skin nor an eye irritant. The transdermal absorption rate of DHA in a cosmetic formula containing 10% DHA was 37.2%(84.4 μg·cm^-2). The no-oberserved effect level(NOEL) of DHA in the 90-day oral toxicity study and reproductive toxicity test was 1000 mg/(kg·d^-1). DHA induced apoptosis in HaCaT keratinocyte cells and A375 P melanoma cells. With or without the addition of S9, DHA was mutagenic in two test strains of Salmonella typhimurium TA100 and TA102. DHA was known to be a contact allergen in human bodies.The conclusion of the safety evaluation of DHA in cosmetics made by European Union was that the use of DHA as a self-tanning ingredient in cosmetic formulations up to 10% and in spray cabins up to 14% will not pose a risk to the health of the consumers. The United States and South Korea have strict regulations in adding DHA to the list of colorants. Conclusion: DHA in cosmetics has potential safety risks to the human body. Risk monitoring and risk assessment for DHA in cosmetics should be paid close attention to and carried out in China.