SLS人体单次斑贴试验阳性对照物基准模型的建立

目的:建立十二烷基磺酸钠(SLS)人体单次斑贴试验阳性基准模型。方法:60名健康受试者使用0.01%、0.05%、0.10%、0.50%和1.00%SLS进行第一阶段皮肤单次斑贴试验,确定阳性对照物的初步合适浓度区间。然后再选取60名健康受试者根据第一阶段合适浓度范围设计浓度进行第二阶段试验,进一步确定合适浓度。结果:第一阶段的试验提示,阳性基准物的浓度在0.01%~0.05%之间,第二阶段确定0.02%SLS的1级皮肤反应人数≤5例,2级皮肤反应人数2例,该反应率与标准中的阳性结果最为接近。结论:建议以0.02%SLS作为人体单次斑贴试验的阳性对照物基准模型。

Establishment of positive control for benchmark in human single patch test

Objective:To establish the positive control for benchmark model of human asingle patch test. Methods:In the first stage, sixty healthy subjects were tested by different concentrations ( 0. 01%、0. 05%、0.10%、0.50% and 1.00%) of sodium lauryl sulphate ( SLS) in single patch test in order to determine the proper concentration. In the second stage, the results obtained from the first stage of the experiment was used to determine the test concentration in 60 study subjects. Results: The positive benchmark concentration was between 0.01%-0.05% in the first study stage. When the concentration of SLS was 0.02%, there was less than 5 subjects in level 1 skin reaction and less than 2 subjects in level 2 skin reaction, which was most close to the positive standard according to the Cosmetics Health Standards 2007. Conclusion:0.02% SLS is appli-cable as a positive control for benchmark in human single patch test.