Combined In Vitro Tests as an Alternative to In Vivo Eye Irritation Tests
Combined In Vitro Tests as an Alternative to In Vivo Eye Irritation Tests
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组合体外测试作为体内眼睛刺激测试的替代方法
DOI：
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发表时间：
2010
期刊：
影响因子：
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通讯作者：
G. Xiang
中科院分区：
文献类型：
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作者：
Yang Ying;Y. Xingfen;Zhang Wengai;Cai JinHeng;Xu Jinyu;Yang Guangyu;Tan Xiaohua;Xie Xiaoping;Xiong Xikun;H. Junming;G. Xiang
为了满足新的监管标准，需要测试化学品眼睛刺激潜力的准确方法，这些方法不涉及使用动物。我们评价了5种体外试验对眼刺激的适用性和预测能力：鸡卵试验-绒毛尿囊膜（HET-CAM）试验;绒毛尿囊膜-台盼蓝染色（CAM-TBS）试验;黄绿素渗漏试验（FLT）; 3 T3-中性红摄取（3 T3-NRU）细胞毒性试验;和红细胞（RBC）溶血试验。通过使用五种试验评估了一组16种化学品（一些在多个浓度下），并将结果与历史体内Draize试验数据进行了比较。结果表明，16种化学品的5种替代方法与Draize试验之间存在等级相关性和类别一致性。与Draize试验相比，这些体外试验具有良好的预测能力、重现性和可靠性。HET-CAM、CAM-TBS和FLT结果与改良最大平均评分（MMAS）之间的相关性最好。基于MMAS与HET-CAM、CAM-TBS和FLT结果之间的最大可能相关性，开发了预测模型（PM）。与动物实验结果相比，PM具有良好的预测能力，表明其对眼刺激作用的化学品体外筛选的潜在价值。
Accurate methods that test the eye irritation potential of chemicals, which do not involve the use of animals, are needed to meet new regulatory standards. We evaluated the applicability and predictive capacity of five in vitro tests for eye irritation: the Hen's Egg Test-Chorioallantoic Membrane (HET-CAM) assay; the Chorioallantoic Membrane-Trypan Blue Staining (CAM-TBS) assay; the Fluorescein Leakage Test (FLT); the 3T3-Neutral Red Uptake (3T3-NRU) cytotoxicity assay; and the red blood cell (RBC) haemolysis assay. A panel of 16 chemicals (some at multiple concentrations) was assessed by using the five tests, and the results were compared with historical in vivo Draize test data. The results showed rank correlation and class concordance between the five alternative methods and the Draize test for the 16 chemicals. These in vitro assays had good predictive capacity, reproducibility and reliability when compared to the Draize test. The best relationship was between the HET-CAM, CAM-TBS and FLT results, and the modified maximum average score(s) (MMAS). A prediction model (PM) was developed, based on the maximum possible correlation between the MMAS and the HET-CAM, CAM-TBS and FLT results. The PM had a good predictive capacity when compared to the results of animal tests, indicating its potential value for the in vitro screening of chemicals for eye irritation effects.