三维重建人角膜模型在化学品眼刺激分类中的实验研究  

Experimental study on the classification of chemical eye irritation using a 3D reconstructed human corneal model

作　　者：孙静秋[1,2] 李晨 霍倩[1,2] 林天音 洪新宇[1,2] 肖萍 陶功华 SUN Jing-qiu;LI Chen;HUO Qian;LIN Tian-yin;HONG Xin-yu;XIAO Ping;TAO Gong-hua(Shanghai Center for Disease Control and Prevention,Shanghai 200336,China;不详)

机构地区：[1]上海市疾病预防控制中心,上海200336 [2]国家药品监督管理局化妆品监测评价重点实验室,上海200336

出　　处：《现代预防医学》2024年第19期3609-3614,共6页Modern Preventive Medicine

基　　金：上海市第六轮公共卫生体系建设三年行动计划项目(GWVI-11.1-41,GWVI-4);上海市化妆品创新研发与检测评价专业技术服务平台(22DZ2292100)。

摘　　要：目的 建立基于国产的三维重建人角膜模型(SkinEthic^(TM) Reconstructed Human Corneal-like Epithelium, SkinEthic^(TM) HCE)多时间点暴露体外眼刺激性试验方法并探讨将此单一体外测试方法应用于化学品眼刺激性评价的可行性及准确性。方法 选取14个已知眼刺激性分类的标准化学品(涵盖三类眼刺激性UN GHS分类),依据OECD TG492B基于SkinEthicTMHCE模型按不同性状将受试物分别暴露于多个时间点,以MTT法测定细胞活性作为检测终点,结合多个时间点的检测结果预测受试物的严重眼损伤/眼刺激UN GHS分类。结果 多时间点暴露体外眼刺激性试验方法对14个化学品两轮测试的眼刺激性分类均正确,且与UN GHS分类结果相一致,整体准确率100%,方法的重现性良好。结论基于国产SkinEthic^(TM) HCE多时间点暴露体外眼刺激性试验方法能有效识别化学品严重眼损伤/眼刺激的三个类别(No Cat、Cat 2和Cat 1),与传统兔眼Draize法相比,其实验周期短、操作步骤简便、检测结果更为客观,可应用于化学品体外眼刺激性评价。Objective To establish an in vitro eye irritation testing method based on the domestically produced 3D reconstructed human corneal model,Skin EthicTM Reconstructed Human Corneal-like Epithelium(HCE),with multiple exposure time points,and to explore the feasibility and accuracy of applying this single in vitro testing method for the evaluation of chemical eye ir-ritation.Methods Fourteen standardized chemicals with known eye irritation classifications(covering three categories of eye irr itation according to UN GHS classification)were selected.Following OECD TG492B guidelines based on the Skin EthicTM HCE model,the test substances were exposed at multiple time points according to different characteristics.MTT assays were utilized to determine cell viability as the endpoint,and the results from multiple time points were combined to predict the UN GHS classification of severe eye damage/eye irritation for the test substances.Results The multiple time point exposure in vitro eye irritation testing method correctly classified the eye irritation of 14 chemicals across two rounds of testing,aligning with the UN GHS classification results,yielding an overall accuracy rate of 100%.The method demonstrated good reproducibility.Conclu-sion The domestically developed Skin EthicM HCE multiple time point exposure in vitro eye rritation testing method effectively identifies three categories of severe eye damage/eye irritation for chemicals(No Category,Category 2,and Category 1).Com-pared to the traditional rabbit eye Draize method,this approach offers a shorter experimental cycle,simpler operational steps,and more objective detection results,making it applicable for the in vitro evaluation of chemical eye irritation.

关 键 词：重建人角膜模型 体外替代 眼刺激分类 

分 类 号：TQ460.72[医药卫生—药物分析学]