牛角膜混浊和渗透性试验方法与家兔法评价染发类化妆品眼刺激性的比较研究

Comparative Study on Eye Irritation Prediction Using Bovine Corneal Opacity Permeability Assay and Draize Test of Hair Dyes

关键词:  牛角膜混浊和渗透性试验  染发剂  眼刺激性  替代方法

Key words:  BCOP  hair dyes  ocular irritation  alternative method

摘要:

目的 探讨在染发类化妆品备案审查中，用牛角膜混浊和渗透性试验（BCOP）代替家兔法（Draize试验）进行眼刺激性评价的可能性。方法 分别用BCOP与Draize试验对14种市售染发剂进行眼刺激性评价，并对评价结果进行比较。结果 对14种染发剂眼刺激性检测的结果表明，Draize试验所得的刺激反应等级为微刺激性-轻刺激性，按现行评审标准，通过率为100%（14/14）；BCOP所得的刺激反应等级为轻微刺激性-严重刺激性，与Draize法分类一致性达到78.6%（11/14），以体外刺激评分值（IVIS）≤25为限值，通过率为78.6%（11/14）；以IVIS≤55为限值，通过率为85.7%（12/14）。结论 用BCOP代替Draize试验对染发类化妆品进行眼刺激性评价可行。

Abstract:

OBJECTIVE To explore the feasibility of the bovine corneal opacity permeability assay instead of Draize test for eye irritation evaluation of hair dyes.METHODS Fourteen kinds of hair dyes form market were selected to predict ocular irritation by BCOP assay,the calculated in vitro irritancy score (IVIS) were compared with the results of Draize in vivo rabbit test.RESULTS The test results of fourteen kinds of hair dyes products showed that the classification results from Draize test was light-moderate irritation,the passing rate was 100%(14/14) according to current standards,the BCOP assay was slight-severe irritation,the total classification consistency of BCOP and Draize test reached 78.6%(11/14),took the IVIS ≤ 25 as limiting value,the passing rate was 78.6%(11/14);and the passing rate was 85.7%(12/14) when the limiting value was IVIS ≤ 55.CONCLUSION The results suggest that BCOP assay can be used in eye irritation evaluation for hair dyes.