基于AOP策略的体外替代试验在化妆品皮肤致敏性评价中的应用  

Application of in vitro alternative tests based on AOP in skin sensitization evaluation of cosmetics

作　　者：应梦超 肖萍[1,2] 洪新宇[1,2] 孙静秋[1,2] 霍倩[1,2] 李晨[1,2] 陈田 陶功华[1,2] YING Meng-chao;XIAO Ping;HONG Xin-yu;SUN Jing-qiu;HUO Qian;LI Chen;CHEN Tian;TAO Gong-hua(NMPA Key Laboratory for Monitoring and Evaluation of Cosmetics,Shanghai Municipal Center for Disease Control&Prevention,Shanghai 200336,China;State Environmental Protection Key Laboratory of the Assessment of Effects of Emerging Pollutants on Environmental and Human Health,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,上海200336 [2]上海市疾病预防控制中心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6期21-26,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);上海市卫生健康委卫生标准预研制项目(编号:2019WB07);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：探讨基于皮肤致敏有害结局通路中第二及第四事件所建立的体外替代试验在化妆品皮肤致敏性测试中应用的可行性及评估策略。以体外培养的DSens及Jurkat细胞作为受试模型,分别采用DSens和TCPA方法对9种标准化学品和特殊类化妆品产品进行测试,通过检测2种方法对应指标的表达水平,对体外皮肤致敏性预测能力进行验证。验证结果显示,DSens法对于致敏强度不同的标准化学品的识别敏感度要高于使用Jurkat细胞作为模型的TCPA法,而应用研究结果显示,2种方法对于12种产品的预测结果与基于AOP第三事件的h-CLAT的判定结果及体内皮肤变态反应的判定结果具有高度的一致性。基于AOP原理的体外皮肤致敏性测试作为化妆品皮肤致敏性评价的一种新型筛查方法具有一定的有效性,采取合理的组合策略能够给我国动物替代试验的发展及应用带来非常良好的前景。Two novel in-vitro alternative tests which based on the 2nd and 4th events of the AOP in skin sensitization and their application in skin sensitization evaluation of cosmetics were evaluated and discussed.DSens and Jurkat cells were used as the test models and nine reference chemicals and 12 kinds of cosmetic products were used to confirm and assess the feasibility of the methods in skin sensitization evaluation.The results show that the DSens method is more sensitive to the reference chemicals compare with the TCPA method.All the results of cosmetic products show that the two assays are highly consistent with h-CLAT or in vivo assay.As new screening methods for skin sensitization evaluation of cosmetics,the in vitro alternative tests based on AOP have certain effectiveness.Reasonable combination of strategies can bring a bright future for the development and application of alternatives to animal testing in China.

关 键 词：体外替代 皮肤致敏性 角质细胞活化 T细胞激活 化妆品安全评估 

分 类 号：TQ658[化学工程—精细化工]