应用BioOcullar^(TM)重建人角膜上皮模型评估化学物和化妆品产品眼刺激性  

Application of BioOcullar^(TM)human corneal epithelium model in evaluating the eye 1V irritation of chemicals and cosmetic products

作　　者：何国群[1] 杨颖[1] 李潇 郑穗生[1] 古梅英[1] 张晓娥 李润芝 HE Guo-qun;YANG Ying;LI Xiao;ZHENG Sui-sheng;GU Mei-ying;ZHANG Xiao-e;LI Run-zhi(Guangdong Provincial Center for Disease Control and prevention,Guangzhou Guangdong 511430,China;Xi'an Institute of tissue engineering and regenerative medicine,Xi'an Shaanxi 710000,China)

机构地区：[1]广东省疾病预防控制中心,广东广州511430 [2]西安组织工程与再生医学研究所,陕西西安710000

出　　处：《毒理学杂志》2023年第2期137-144,共8页Journal of Toxicology

基　　金：国家药品监督管理局化妆品风险评估重点实验室开放课题(KF2021013)。

摘　　要：目的采用BioOcullar^(TM)重建人角膜上皮模型检测化学物和化妆品产品的眼刺激性,以评价基于该模型的测试方法对化学物和化妆品眼刺激性评估能力。方法检测化学物时,选用58种化学物,暴露于角膜上皮模型后,用噻唑蓝(MTT)法测定角膜组织活性,计算组织相对活性值,当组织相对活性≤60%时,判定受试物为刺激性阳性,当组织相对活性>60%时,判定为刺激性阴性。检测化妆品产品时,选用61种不同类型化妆品,采用时间毒性效应二步法,根据测试结果划定刺激性分级标准。分析测试方法对化学物和化妆品眼刺激性检测的灵敏度、特异度和符合率。结果对58种化学物的眼刺激性检测,其中25种化学物3轮重复测试刺激性分类均为一致,且与欧洲化学品管理局分类、标签和包装数据库(Classification,Labelling&Packaging,CLP)或全球化学物统一分类和标签系统(Globally Harmonized System of Classification and Labelling of Chemicals,GHS)分类一致;扩大对33种化学物检测,有32种结果与CLP或GHS分类结果一致,对58种化学物眼刺激性检测的灵敏度为100%,特异度为95.00%,符合率为98.28%。对61种化妆品1 h筛检结果,有26份化妆品划分为无刺激性或微刺激性,符合率为100%;对余下的35份疑似刺激性化妆品检测,参照动物试验结果划定刺激性分级标准为:ET50>36.5 min为无刺激或微刺激性,5 min<ET50≤36.5min为轻刺激性,ET50≤5min为中刺激性或以上;时间毒性效应二步法结果表明,对61种化妆品检测的灵敏度为96.77%,特异度为93.33%,符合率为95.08%。结论基于BioOcullar^(TM)人角膜上皮模型的体外检测方法对化学物和化妆品产品眼刺激性评估均具有较高的效能。Objective To evaluate the effectiveness of BioOcullar^(TM) human corneal epithelium model in detecting eye irritation of chemicals and cosmetics.Methods The corneal epithelium model were exposed to 58 chemicals selected.The corneal tissue activity was measured by MTT method and the relative activity value of the tissue was calculated.When the relative activity of the tissue was less than or equal to 60%,the tested substance was judged as positive irritation,and when the relative activity of the tissue was more than 60%,the tested substance was judged as negative irritation.The two-step method of time-to-toxicity assay was used to detect eye rritation of 61 cosmetics.The sensitivity,specificity and coincidence rate of the test method for chemical and cosmetic eye irritation detection were analyzed.Results Compared with the Classification Labelling&Packaging being available by the data-bases of the European Chemicals Agency(CLP)or classification being available by the Globally Harmonized System of Classification and Labelling of Chemicals(GHS).The sensitivity,specificity and coincidence rate of 58 chemicals were 100%,95.00%and 98.28%by using Bio0cullarM reconstruction of humancorneal epithelial model.Compared with animal test result,the two-step methodof Time-to-Toxity asay based on Biooullarm corneal model showed that the sensitivity,specificity and coincidence rate of 61 cosmetics were 96.77%,93.33%and 95.08%respectively.Conclusion The method based on BioOcullar^(TM) human corneal epithelial model has high fficiency in the detection of chemical and cosmetic eyeirritationinvitro.

关 键 词：角膜上皮模型 化学物 化妆品 眼刺激性 

分 类 号：R114[医药卫生—卫生毒理学] R331[医药卫生—公共卫生与预防医学] R99