牛角膜浑浊渗透试验方法预测眼刺激性的研究  

Research on eye irritation prediction using bovine corneal opacity and permeability test

作　　者：黄健聪[1,2] 秦瑶[1] 程树军[1] 徐嘉婷 陈彧[2] 

机构地区：[1]广东出入境检验检疫技术中心,广东广州510623 [2]广东药学院,广东广州510130

出　　处：《中国卫生检验杂志》2014年第14期1980-1983,共4页Chinese Journal of Health Laboratory Technology

基　　金：国家科技支撑计划(2011BAI15B03)

摘　　要：目的建立牛角膜浑浊及渗透试验(BCOP)方法并评价其眼刺激性预测能力。方法采用15种标准眼刺激化学参考物建立BCOP实验方法,并对45种市售个人护理产品进行眼刺激性预测,测定经测试物暴露后的角膜混浊度和荧光素纳渗透性变化,得到体外评分值。同时以体内兔眼试验为对照进行比较。结果经15种已知分类的眼刺激化合物检测表明,BCOP方法可区分无刺激性和严重刺激性物质,与体内实验一致。对未知样品的测试表明BCOP对严重/腐蚀性的预测敏感性为100%(3/3),对中度-轻度刺激性的预测敏感性为95.8%(23/24),对无刺激性的预测特异性为83.3%(15/18)。与体内试验总的分类一致性达到91%(41/45),阳性预测值为89.7%(26/29),阴性预测性为93.8%(15/16)。假阳性率为16.7%(3/18),假阴性率为3.7%(1/27)。结论 BCOP替代方法可用于化学品分类和作为整合策略的主要方法用于个人护理品的眼刺激评价。Objective To establish bovine corneal opacity and permeability （BCOP） test method and evaluate its predictive ability to eye irritation. Methods Fifteen kinds of standard reference chemicals of eye irritation were selected to establish the BCOP method. Forty - five kinds of personal - care products from market were selected to predict ocular irritation, and the o- pacity and fluorescein permeability changes were determined after the cornea exposure to the test samples to calculate the in vitro irritancy score. At the same time, the results of Draize in vivo rabbit test as control were used for comparison. Results The test results of the 15 known eye irritant chemicals showed that the BCOP method can be used for identification of nonirritating and severe - irritated substances, consistent with the Draize test in vivo. The results of unknown sample tests showed that the sensitivity of BCOP method to severe/corrosion irritation prediction was 100% （3/3）, to light - moderate irritation was 95.8% （23/24）. While the specificity of that to non -irritation prediction was 83.3% （15/18）. The total classification consistency of BCOP and Draize test reached 91% （41/45）, and the positive predictive was 89.7% （26/29）, the negative predictive was 93.8% （ 15/16）, the false positive rate was 16.7% （3/18） and the false negative rate was 3.7% （1/27）. Conclusion The BCOP method can be applied to classify chemicals and as the main method in integration testing strategy for predicting ocular irritation of personal care products.

关 键 词：牛角膜浑浊及渗透试验 眼刺激性 个人护理品 替代方法 

分 类 号：R136.4[医药卫生—劳动卫生]