人源THP-1细胞系活化试验在化妆品皮肤致敏性评价中的应用研究  

Application of THP-1 human cell line activation test in skin sensitization evaluation of cosmetics

作　　者：李晨[1] 沙毅杰 霍倩[1] 孙静秋[1] 王彦琴[1] 刘蕾 肖萍[1] 陶功华[1] LI Chen;SHA Yi-jie;HUO Qian;SUN Jing-qiu;WANG Yan-qin;LIU Lei;XIAO Ping;TAO Gong-hua(Shanghai Center for Disease Control and 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：《现代预防医学》2022年第2期349-353,379,共6页Modern Preventive Medicine

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(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：目的建立基于人源THP-1细胞系的皮肤致敏性体外替代测试方法(h-CLAT),探讨其应用于化妆品体外皮肤致敏性评价的可行性。方法参考OECD 442E测试指南,通过对10种标准化学品的致敏性预测建立h-CLAT试验方法,验证其准确性及灵敏度,再对10种特殊类化妆品产品进行皮肤致敏性评价,并与体内皮肤变态反应判定结果进行比较分析。结果使用h-CLAT方法准确判定了10种标准化学品的皮肤致敏性,10种化妆品产品中,9种产品的预测结果与体内皮肤变态反应的判定结果具有一致性,均为无致敏性,1种产品被判定为具有潜在致敏性,与动物试验结果不一致。结论基于有害结局路径(AOP)AOP理论,体外人源细胞系活化试验可作为化妆品皮肤致敏性评价的一种筛查方法,但针对体外替代试验的局限性,仍需整合其他测试方法进行皮肤致敏性预测。Objective To establish an in vitro alternative test of skin sensitization based on THP-1 human cell line,and to discuss the possibility of its application in skin sensitization evaluation of cosmetics in vitro.Methods According to Organization for economic cooperation and development(OECD) 442 E Guideline,the skin sensitization of 10 kinds of reference chemicals was tested by the established h-CLAT test to verify its accuracy and sensitivity.The skin sensitization of 10 kinds of special cosmetics was evaluated,the results of which were compared with the traditional skin sensitization test in vivo.Results The skin sensitization of 10 reference chemicals was accurately identified by the h-CLAT method.Among the tested10 cosmetic products,the predictions of nine samples were consistent with the identified results of skin allergy test,all of which were no-sensitization.One sample was predicted to have the potential sensitization,which was inconsistent with the result of the in vivo test.Conclusion In terms of the adverse outcome pathway(AOP) for skin sensitization,h-CLAT test can be used as a screening method for the evaluation of skin sensitization of cosmetics,but in view of the limitations of alternative tests in vitro,other methods should be integrated to make a prediction.

关 键 词：皮肤致敏性 h-CLAT 体外替代方法 化妆品 

分 类 号：R758.2[医药卫生—皮肤病学与性病学]