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一种体外皮肤腐蚀性试验替代方法的建立

             

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.

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