一种体外皮肤腐蚀性试验替代方法的建立  

Verification and application of the rat skin transcutaneous electrical resistance test( TER) as an alternative method to replace the animal skin corrosion test

作　　者：罗飞亚[1] 张露勇[1] 邢书霞[1] 王钢力[1] LUO Feiya, ZHANG Luyong, XING Shuxia, WANG Gangli(National Institutes of Food and Drug Control, Beijing 100050,Chin)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国实验动物学报》2018年第3期365-371,共7页Acta Laboratorium Animalis Scientia Sinica

摘　　要：目的建立皮肤腐蚀性的体外检测方法—大鼠经皮电阻试验(TER),优化OECD指南标准TG 430大鼠经皮电阻方法结果判定标准,并评价该方法作为替代方法用于评估化妆品原料的皮肤腐蚀性检测可行性。方法参照经合组织(OECD)化学品检测指南中TG 430体外皮肤腐蚀性大鼠经皮电阻试验的流程,使用Wistar大鼠对16种参考化学物质进行皮肤腐蚀性检测,设定不同的判定标准方案,通过对比筛选出最优的判定标准方案;并在5个实验室间进行11种参考物质的结果比对。结果改良后的TER结果判定方案结论与参考化学物质的实际腐蚀性结果具一致性(Kappa值0.64),改良方案B的特异性为66.7%,敏感性为100%,效能最高;实验室间比对结论差异无显著性(P>0.05),实验室间对11种参考物质的判定一致率为72.7%。结论经改良的大鼠经皮电阻试验可较好的筛选化学物质的腐蚀性,有望在我国的替代毒理学及化学物质安全性评价中发挥重要的作用。Objective In order to verify an alternative method for the skin corrosion test by using transcutaneous electrical resistance（ TER） test,and to optimize the implementation criteria in OECD TG 430 procedure. Methods According to the OECD TG 430 procedure,Wistar rat skin was used to test the TER values of 16 reference chemicals,and selected the most optimal standard via different implementation criteria. The program B was chosen to make inter-laboratory comparison between 5 laboratories by testing 11 chemicals,which were identified as the optimal standard. Results After the TER test,the result of corrosion test of 16 chemicals were accordant with the reference data（ Kappa value = 0. 64）.The program B was the most optimal implementation criteria,and the specificity was 66. 7% and sensitivity was 100%.There were no significant differences between the corrosion estimations of 5 laboratories,and the concordance rate of the 5 laboratories was 72. 7%. Conclusions Transcutaneous electrical resistance（ TER） test is an feasible and efficient tool for skin corrosion testing,and may become a good interim test to replace the in vivo test with this ex vivo test in cosmetics chemical safety assessment,thus,to reduce the animal usage in our country.

关 键 词：大鼠经皮电阻试验 皮肤腐蚀性 替代方法 安全性评价 离体皮肤 

分 类 号：Q95-33[生物学—动物学]