【作者】 杨颖； 杨杏芬； 张文改； 贺锡雯； 杨光宇； 谭小华； 谢晓萍； 熊习昆； 郭翔；

【Author】 Yang ying~1,Yang xingfen~1,Zhang wengai~(1,2),Yang Guangyu~1,Tan Xiaohua~1,Xie Xiaoping~1, Xiong xikun~1,Huang Junming~1,Guo Xiang~(1,2) 1 Center for Disease Control and Prevention of Guangdong Province,Guangzhou 510300 2 School of Public Health,Sun Yat-sen University,Guangzhou 510080

【机构】 Center for Disease Control and Prevention of Guangdong Province； School of Public Health,Sun Yat-sen University；

【摘要】 目的:探讨将五项眼刺激体外替代试验应用于化妆品进行同步联合评价,用以替代动物眼刺激性试验(Draize试验)的可能性。方法:选择27种化妆品分别进行鸡胚尿囊膜绒毛膜试验(HET-CAM)、鸡胚尿囊膜苔盼蓝染色试验(CAM-TBS)、荧光素漏出试验(FLT)、红细胞溶血试验、3T3中性红摄取细胞毒性试验,同步进行动物Draize试验,并将五种方法的刺激性分级结果与动物实验进行比较,采用SPSS软件和最小二乘法进行统计分析。结果:五种方法对化妆品的分级结果与动物实验比较均有较好的分级一致性和等级相关性,HET-CAM、CAM-TBS、FLT对动物实验结果相关性的贡献系数相对较大(大于1)。以动物实验结果MMAS作为因变量,HET-CAM、FLT、CAM-TBS三项体外试验结果作为自变量建立的眼刺激体外替代预测方程,预测值与实际值之间拟合程度较好,分级准确率为76.9%。结论:HET-CAM、FLT、CAM-TBS三项眼刺激体外替代试验同步联合应用建立的眼刺激体外替代预测方程对化妆品具有较好的预测能力、重复性和可靠性,作为化妆品眼刺激性评价的筛选具有很好的应用价值。更多还原

【Abstract】 Object:To evaluate the applicability and predictive capacity by allying the five in vitro tests for eye irritation,and try to find better testing methods for eye irritation of cosmetic.Methods:27 cosmetic products were assessed in the study,they were tested by the five alternative methods for eye irritation tests,including HET-CAM,CAM-TBS,FLT,3T3-NRU cytotoxicity assay and red blood cell(RBC) haemolysis assay,meanwhile the cosmetics were tested by in vivo Draize test,In vivo tests comparison with in vitro tests was analyzed with SPSS software.Results:It was shown that ranking correlation and class concordance existed between the five alternative methods and Draize test by applying 27 cosmetic products,the relationship between HET-CAM、CAM-TBS、FLT and MMAS is better,a predictive model was developed of Y from X,subject to the maximum possible correlation between the MMAS and HET-CAM、CAM-TBS、FLT.from X Conclusion:It is suggested that the three in vitro assays,HET-CAM,CAM-TBS,FLT had good predictive capacity, reproducibility and reliability when compared with Draize test,a predictive model is of well application value as a screening test in cosmetics safety evaluation.更多还原