摘要
采用危害识别、剂量反应关系评估、暴露评估和风险特征描述的风险评估程序,对化妆品中本维莫德进行风险评估。动物试验和临床不良反应数据显示本维莫德可引起皮肤刺激反应,具有生殖发育毒性,对新西兰白兔胚胎-胎儿发育影响的未观察到有害作用的剂量(NOAEL)为1 mg/(kg·d),计算得出全身暴露量为0.99 mg/(kg·d),安全边际值(MoS)为1。结果表明化妆品中本维莫德对人体具有潜在安全风险,应尽快制定化妆品中本维莫德的管理规定,将其纳入《化妆品禁用原料目录》进行管理。
The risk assessment of benvitimod in cosmetics was carried out according to the procedures of hazard identification,dose-response relationship assessment,exposure assessment and risk characteristics description.The results of animal tests and clinical adverse reaction cases showed that benvitimod could cause skin irritation,reproductive and developmental toxicity.The NOAEL for benvitimod effects on rabbit embryo-fetal development toxicity was 1 mg/(kg·d).Systemic exposure dosage was 0.99 mg/(kg·d)and the margin of safety(MoS)was 1.The results indicated that benvitimod in cosmetics had potential safety risks to the human body.It should be included in the List of Substances Prohibited in Cosmetic Products as management regulation in China as soon as possible.
作者
裴新荣
邢书霞
PEI Xinrong;XING Shuxia(Institute for Cosmetics Control,National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《香料香精化妆品》
CAS
2023年第6期51-55,共5页
Flavour Fragrance Cosmetics
基金
国家重点研发计划(编号2022YFF0711105)。
