苄索氯铵原料毒理学评价  

Toxicological safety evaluation of Benzethonium chloride

作　　者：陈耿[1] 刘协[1] 石根勇[1] 施伟庆[1] 徐德洲[1] 吕中明[1] 奚清丽[1] CHEN Geng;LIU Xie;SHI Gen-yong;SHI Wei-qing;XU De-zhou;LV Zhong-ming;XI Qing-li(Jiangsu Provincial Center for Disease Control and Prevention,Nanjing Jiangsu 210009,China)

机构地区：[1]江苏省疾病预防控制中心,江苏南京210009

出　　处：《中国消毒学杂志》2022年第10期733-736,共4页Chinese Journal of Disinfection

摘　　要：目的 评价苄索氯铵原料的毒理学安全性。方法 采用小鼠急性经口毒性试验、家兔多次完整皮肤刺激试验、家兔多次阴道黏膜刺激试验、豚鼠皮肤变态反应试验等方法,对苄索氯铵的急性毒性、刺激性和致敏性进行研究。结果 苄索氯铵对雌、雄ICR小鼠的急性经口LD_(50)值均为316 mg/(kg·bw)[95%CI:205~488 mg/(kg·bw)]。5 000 mg/L苄索氯铵水溶液对新西兰白兔完整皮肤刺激指数为0.8,多次阴道黏膜刺激指数为1.9;对豚鼠皮肤致敏率为0%。结论 苄索氯铵原料为中等毒性物质;其5 000 mg/L水溶液对完整皮肤、黏膜分别为轻刺激性和极轻刺激性,且无皮肤致敏性。Objective To evaluate the toxic effects of benzethonium chloride.Methods Mice acute oral toxicity test, multiple-time dermal irritation test and multiple-time vaginal mucosa irritation test in New Zealand white rabbits, skin sensitization test in guinea pigs were conducted to test the toxic effects.Results The acute oral LD_(50) values of benzethonium chloride in male and female ICR mice were both 316 mg/(kg·bw)[95%CI:205-488 mg/(kg·bw)].The average dermal irritation scores per day per animal and the vaginal mucosa primary irritation index(PII) of 5 000 mg/L benzethonium chloride in New Zealand white rabbits were 0.8 and 1.9.The allergy rate of 5 000 mg/L benzethonium chloride in guinea pigs was 0%.Conclusion Benzethonium chloride belonged to the middle-grade toxicity, and 5 000 mg/L benzethonium chloride belonged to mild irritant and negligible irritant for derma and the vaginal mucosa respectively, without skin allergic reaction.

关 键 词：苄索氯铵 毒理学 消毒产品 安全性 

分 类 号：R187.1[医药卫生—流行病学]