人重组皮肤模型评价手消毒剂产品皮肤刺激性的应用研究  

Application study on the skin irritation evaluation of hand disinfectant products using reconstructed human epidermis model

作　　者：邓晗依 孙静秋[1] 肖萍[1] 李晨[1] 霍倩[1] 沙毅杰 王乐天 陶功华[1] DENG Han-yi;SUN Jing-qiu;XIAO Ping;LI Chen;HUO Qian;SHA Yi-jie;WANG Le-tian;TAO Gong-hua(NMPA Key Laboratory for Monitoring and Evaluation of Cosmetics and State Environmental Protection Key Laboratory of Environmental Health Impact Assessment of Emerging Contaminants,Shanghai Municipal Center for Disease Control&Prevention,Shanghai 200336,China)

机构地区：[1]上海市疾病预防控制中心国家药品监督管理局化妆品监测评价重点实验室、国家环境保护新型污染物环境健康影响评价重点实验室,上海200336

出　　处：《日用化学品科学》2022年第3期32-37,共6页Detergent & Cosmetics

基　　金：上海市“创新行动计划”自然科学基金项目(19ZR1451200);上海市第四轮公共卫生三年行动计划“高端海外研修团队培养计划”(GWTD2015S03)。

摘　　要：采用人重组皮肤模型(EpiSkin^(TM))作为实验模型,通过联合测定细胞活性和白介素-1α(IL-1α)来综合评估14个市售手消毒剂产品的皮肤刺激性,其中4个免洗型产品暴露4 h,10个非免洗型产品分别暴露2 h和4 h,将得到的结果分别与动物试验(Draize试验)结果进行对比。结果显示,在皮肤刺激性试验中,经Draize试验判定为中刺激性的两个产品,人重组皮肤模型均能有效鉴别。采用上样时间4 h,14个产品的人重组皮肤模型和动物试验结果的准确度为57.1%、特异度为50%。对其中10个非免洗型产品采用2 h上样,其准确度可达到71.4%、特异度可提高至66.7%。研究表明,人重组皮肤模型在手消毒剂产品的皮肤刺激性评价中具有一定的可行性,根据产品的使用特性进行暴露时间的优化可为消毒剂产品皮肤刺激体外测试标准方法的建立提供实验室依据。EpiSkin^(TM) model was used to evaluate the skin irritation of 14 hand disinfectant products available in the market according to cellular activity and IL-1αreleasing level,the results of which were compared with those of animal experiments(Draize test).An exposure time of 4 h was adopted for four wash-free products,while for the other 10 products 2 h and 4 h were adopted.The predictive ability of reconstructed human epidermis model was systematically evaluated.The two products determined to be moderately irritating by Draize test could be effectively identified by reconstructed human epidermis model.The specificity and consistency of the reconstructed human skin model reached 50%and 57.1%under the exposure time of 4 h compared with Draize test.While the exposure time of 2 h was used for the hand disinfectant products of cleaning type,the specificity was up to 66.7%and the consistency reached 71.4%.This study shows that the reconstructed human epidermis model is feasible in the skin irritation evaluation of hand disinfectant products.The optimization of exposure time according to the type of disinfectant products can provide a laboratory basis for establishing the standard methods of in vitro test for skin irritation thereof.

关 键 词：消毒剂 人重组皮肤模型 IL-1Α 皮肤刺激性 

分 类 号：TQ657[化学工程—精细化工]