基于重组人角膜模型SkinEthic^TM的化学品眼刺激性体外替代方法研究  

In vitro study of eye irritating chemicals using the SkinEthic^TM reconstructed human corneal epithelium

作　　者：霍倩[1] 帅怡[1] 孙静秋[1] 李晨[1] 蔡臻子 赵锷 李楠 刘砚枫 陶功华[1] HUO Qian;SHUAI Yi;SUN Jing-qiu;LI Chen;CAI Zhen-zi;ZHAO E;LI Nan;LIU Yan-feng;TAO Gong-hua(Shanghai Municipal Center for Disease Control&Prevention,Shanghai 200336,China)

机构地区：[1]上海市疾病预防控制中心,上海200336 [2]欧莱雅中国研发和创新中心,上海201206 [3]上海斯安肤诺生物科技有限公司,上海201203

出　　处：《现代预防医学》2020年第20期3769-3772,3776,共5页Modern Preventive Medicine

基　　金：上海市科学技术委员会“创新行动计划”项目(17140900900);上海市卫生健康委员会青年项目(20174Y0103)。

摘　　要：目的建立重组人角膜模型SkinEthicTM体外替代方法并探讨其用于化学品眼刺激性评价的预测能力。方法选取11种已知刺激性分类的标准化学品(包括5种固体化学品和6种液体化学品;涵盖不同溶解度、含自身颜色反应以及与MTT发生直接还原反应的化学品),采用重组人角膜模型SkinEthicTM评估其作为体外眼刺激性替代方法的可行性。以MTT法测定细胞活性作为检测终点,设置相对细胞存活率50%(固体)或60%(液体)为判定依据来预测刺激性和非刺激性。结果11种已知刺激性分类的化学品经重组人角膜模型测试,其中7种被正确评价为刺激性物质(3种固体和4种液体),4种被评价为非刺激性物质(2种固体和2种液体)。评价方法在灵敏度与特异性方面均表现良好,可区分无危险性分类和具有潜在风险性(严重眼损伤/眼刺激性)的化学品,得到的分类结果和UN GHS分类结果一致。结论基于重组人角膜模型SkinEthicTM的眼刺激性体外替代方法可用于快速预测和评价无危险性分类和严重眼损伤/眼刺激性化学物质。Objective The aim of this study was to establish SkinEthicTM human corneal epithelium eye irritation test(SkinEthicTMHCE EIT) and evaluate its predictive ability to eye irritation. Methods 11 kinds of reference chemicals(five solids and six liquids) with known irritant classes were selected to establish the SkinEthicTMHCE EIT. Test chemicals covered different chemical classes and physicals state, including colored chemicals and/or MTT reducers. MTT assay was used to calculate the tissue viability. For solid chemicals, if the % viability was > 50%, it was predicted as No category. If the %viability was ≤50%, the chemical was predicted as "No prediction can be made(No Pred)". For liquid chemicals, if the %viability was >60%, it was predicted as No category. If the % viability was ≤60%, the chemical was predicted as No Pred.Results All of the 11 chemicals assessed in this study were properly identified with SkinEthicTM HCE EIT, 7 of which were correctly classified as No Pred(3 solids and 4 liquids) and 4 as No category(2 solids and 2 liquids). SkinEthicTMHCE EIT was able to correctly identify chemicals predicted as No Cat and chemicals predicted as No Pred. The classification results were consistent with those of UN GHS. Conclusion SkinEthicTM HCE EIT can be used as a rapid screening test for distinguishing chemicals with potential eye irritation/serious eye damage(No Pred) and No Cat.

关 键 词：重组人角膜模型 眼刺激性 体外替代 

分 类 号：R114[医药卫生—卫生毒理学]