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作 者:所雅琼 张凤兰[2] 罗飞亚[2] 裴新荣[2] 邢书霞[2] 王钢力[2] SUO Yaqiong;ZHANG Fenglan;LUO Feiya;PEI Xinrong;XING Shuxia;WANG Gangli(Beijing Likang Hospital,Beijing 102600,China;National Institute for Food and Drug Control,Beijing 100050,China)
机构地区:[1]北京市利康医院,北京102600 [2]中国食品药品检定研究院,北京100050
出 处:《香料香精化妆品》2024年第3期46-51,127,共7页Flavour Fragrance Cosmetics
摘 要:建立U937细胞系激活试验(U-SENS^(TM))方法,并评价该方法作为体外替代方法用于评估化妆品原料的皮肤致敏性检测的可行性。参照经合组织(OECD)化学品检测指南的TG 442E中U-SENS^(TM)试验流程,对16种化学物质进行检测,并在4个实验室进行8种参考物质的盲样检测。结果显示,其中15种受试物检测结果与小鼠局部淋巴结试验(LLNA)方法的结果均一致,与LLNA相比总体准确性为100%(15/15),与人体数据相比总体准确性为85%(11/13);4个实验室对8种OECD参考物质检测的准确率均为100%。成功建立了U-SENSTM试验方法,为筛选皮肤致敏原提供参考。U937 cell line activation assay(U-SENS^(TM))as an animal alternative method was established to evaluate the feasibility for skin sensitization of cosmetic ingredients.Referring to the experimental process of U-SENS^(TM) in OECD TG 442E,16 chemical substances were tested and compared with the blind sample testing results of 8 reference substances in 4 laboratories.The results showed that 15 test substances were consistent with the results from LLNA,with an overall accuracy of 100%(15/15)compared with LLNA and 85%(11/13)compared with human data.The accuracy of detection results of 8 reference substances from 4 laboratories were 100% accurate.The U-SENS^(TM) method was established successfully to provide a reference for screening the skin allergens.
关 键 词:化妆品 动物替代方法 U-SENS^(TM) 皮肤致敏
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