霍倩, 沙毅杰, 肖萍, 洪新宇, 王乐天, 郑卫东, 卫琦, 董铖, 陶功华. 牛角膜混浊和渗透性试验在化妆品眼刺激性评价中的应用[J]. 上海预防医学, 2022, 34(2): 183-186. DOI: 10.19428/j.cnki.sjpm.2022.21430
引用本文: 霍倩, 沙毅杰, 肖萍, 洪新宇, 王乐天, 郑卫东, 卫琦, 董铖, 陶功华. 牛角膜混浊和渗透性试验在化妆品眼刺激性评价中的应用[J]. 上海预防医学, 2022, 34(2): 183-186. DOI: 10.19428/j.cnki.sjpm.2022.21430
HUO Qian, SHA Yijie, XIAO Ping, HONG Xinyu, WANG Letian, ZHENG Weidong, WEI Qi, DONG Cheng, TAO Gonghua. Application of bovine corneal opacity and permeability test in the eye irritation evaluation of cosmetics[J]. Shanghai Journal of Preventive Medicine, 2022, 34(2): 183-186. DOI: 10.19428/j.cnki.sjpm.2022.21430
Citation: HUO Qian, SHA Yijie, XIAO Ping, HONG Xinyu, WANG Letian, ZHENG Weidong, WEI Qi, DONG Cheng, TAO Gonghua. Application of bovine corneal opacity and permeability test in the eye irritation evaluation of cosmetics[J]. Shanghai Journal of Preventive Medicine, 2022, 34(2): 183-186. DOI: 10.19428/j.cnki.sjpm.2022.21430

牛角膜混浊和渗透性试验在化妆品眼刺激性评价中的应用

Application of bovine corneal opacity and permeability test in the eye irritation evaluation of cosmetics

  • 摘要:
    目的 建立牛角膜混浊和渗透性(bovine corneal opacity and permeability, BCOP)试验,并探讨其用于化妆品眼刺激性评价的预测能力。
    方法 选取10种参考化学品进行BCOP试验,并对本实验室日常受理的16件化妆品进行眼刺激性预测。检测受试物暴露后角膜混浊度和荧光素钠渗透性2项参数的变化,计算体外评分值,并与传统动物实验历史数据进行比对分析。
    结果 10种已知刺激性分类的参考化学品经BCOP试验测试评价后均被正确分类,得到的分类结果与全球化学品统一分类和标签制度分类结果一致。化妆品的BCOP测试结果显示,BCOP试验对无刺激性样品检测的特异度为80.0%(8/10),对弱到中刺激的预测灵敏度为83.3%(5/6),与体内试验比对,总体分类一致性达81.3%(13/16)。
    结论 BCOP试验可单独用于识别无危险性分类和具有严重眼损伤或眼刺激性的化学品,在化妆品眼刺激性体外整合测试策略中具有重要的应用价值。

     

    Abstract:
    Objective To establish bovine corneal opacity and permeability (BCOP) test, and determine its predictive ability for the eye irritation evaluation of cosmetics.
    Methods A total of ten reference chemicals were selected to establish the BCOP test. Then eye irritation of 16 routinely collected cosmetics in our laboratory was predicted. In vitro scores were calculated by the change in the opacity and sodium fluorescein permeability after exposure to the testing cosmetics, and subsequently compared with the historical data by Draize test.
    Results Reference chemicals with known irritation classification were correctly classified by the BCOP test, which was consistent with the classification of UN globally harmonized system of classification and labeling of chemicals. Moreover, the specificity of the BCOP test for the classification of non-irritating cosmetics samples was 80.0% (8/10), and the sensitivity for weak to mild irritating cosmetics samples was 83.3% (5/6). The BCOP test demonstrated an overall classification consistency of 81.3% (13/16) with in vivo test.
    Conclusion BCOP test may be independently used to identify chemicals with potential eye irritation and serious eye damage, suggesting it is significant for in vitro integrated test strategy for predicting eye irritation due to cosmetics.

     

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