两品系大鼠经皮电阻试验结果的比较  

Comparison of two strains of rats used in transcutaneous electrical resistance test

作　　者：罗飞亚[1] 冯克然[1] 张露勇[1] 胡培丽[1] 邢书霞[1] 王钢力[1] LUO Feiya;FENG Keran;ZHANG Luyong;HU Peili;XING Shuxia;WANG Gangli(National Institutes of Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国比较医学杂志》2018年第10期61-66,共6页Chinese Journal of Comparative Medicine

摘　　要：目的分析比较Wistar大鼠和SD大鼠大鼠经皮电阻试验(TER)结果。方法参照OECD化学品安全性评价指南和我国《化妆品安全技术规范》中的体外皮肤腐蚀性大鼠经皮电阻试验的流程,分别使用Wistar大鼠和SD大鼠对12种参考化学物质进行皮肤腐蚀性检测,对比分析两个品系两种不同判定标准判定的腐蚀性结果。结果两品系大鼠使用OECD指南方法对12种参考化学物质皮肤腐蚀性判定结论一致,灵敏性均为50%,特异性均为100%;在使用《化妆品安全技术规范》判定皮肤腐蚀性时,两品系大鼠对4-甲硫基-苯甲醛腐蚀性判定结论不一致,其余11种参考物质判定均一致,Wistar大鼠灵敏性100%,特异性83.3%,SD大鼠灵敏性和特异性均为100%。结论两品系大鼠经皮电阻试验结果基本一致,SD大鼠更适合应用于大鼠经皮电阻试验的检测。Objective To analyze and compare the skin corrosion of Wistar and SD rats by using the transcutaneous electrical resistance(TER)test method.Methods In accordance with the OECD TG 430 procedure and Chinese Safety and Technical Standards for Cosmetics,Wistar rats and SD rats were used to test the skin corrosivity of 12 reference chemicals,with the result being compared between the two strains.Results After testing by TER,the result for the two strains of rats,using the OECD guidelines,showed the same conclusion for the corrosivity of the 12 chemicals;the sensitivity was 50%and the specificity was 100%.When using the Chinese Safety and Technical Standards for Cosmetics,the findings for the two strains of rats were not consistent with the judgment on the corrosion associated with 4-(methylthio)-benzaldehyde,while the same conclusion of corrosivity were made for the other 11 reference chemicals.The sensitivity for the Wistar rats was 100%and the specificity was 83.3%,while the sensitivity and specificity for the SD rats were all 100%.Conclusions The two strains of rats showed result largely in accordance with the skin corrosion result upon the testing of 12 reference chemicals by TER.SD rats could thus be used instead of Wistar rats in the TER test.

关 键 词：品系对比 大鼠经皮电阻试验 皮肤腐蚀性 替代方法 离体皮肤 

分 类 号：R-33[医药卫生]