Takahashi Yutaka, Hayashi Takumi, Koike Mirei, Sakaguchi Hitoshi, Kuwahara Hirofumi, Nishiyama Naohiro
Kao Corporation, Haga, Tochigi, Japan.
Cutan Ocul Toxicol. 2010 Jun;29(2):77-90. doi: 10.3109/15569521003587327.
We have developed the short time exposure (STE) test using a rabbit corneal cell line (SIRC cells) as an alternative eye irritation test. The STE test uses relative viability as the endpoint after cells are exposed to the test material at 5%, 0.5%, and 0.05% concentrations for 5 minutes. In this interlaboratory study, 2 laboratories conducted the test using 70 raw materials in order to evaluate transferability, between-laboratory reproducibility, and predictive capacity of the STE test as an alternative eye irritation test. Transferability was assessed using saline as a negative control and 0.01% sodium lauryl sulfate as a positive control. The relative viabilities obtained for the 2 laboratories were almost the same. Therefore, transferability was considered to be excellent. The 2 laboratories showed similar relative viabilities for all 70 raw materials at each test concentration. The correspondence rates of the eye irritation categories (irritants and nonirritants) were over 97% for each concentration tested, exhibiting high between-laboratory reproducibility. The correspondence rates for predicting eye irritation potential of undiluted raw materials and a diluted solution (10%) were over 85% at each laboratory for the 5% and 0.05% test concentrations in the STE. Lastly, the correspondence rate for the rank classification by the STE test prediction model at each laboratory was over 72%, and the correspondence rate became almost 90% when acids, amines, and alcohols were excluded from the analysis. From the above data, excellent transferability, high between-laboratory reproducibility, and high predictive capacity of the STE test were observed in the interlaboratory study by 2 laboratories.
我们开发了一种短时间暴露（STE）试验，使用兔角膜细胞系（SIRC细胞）作为替代眼刺激试验。STE试验以细胞在5%、0.5%和0.05%浓度下暴露于试验材料5分钟后的相对活力作为终点。在这项实验室间研究中，2个实验室使用70种原材料进行了该试验，以评估STE试验作为替代眼刺激试验的可转移性、实验室间再现性和预测能力。使用生理盐水作为阴性对照，0.01%月桂醇硫酸钠作为阳性对照来评估可转移性。两个实验室获得的相对活力几乎相同。因此，可转移性被认为非常好。两个实验室在每个试验浓度下对所有70种原材料都显示出相似的相对活力。在每个测试浓度下，眼刺激类别（刺激物和非刺激物）的符合率均超过97%，显示出较高的实验室间再现性。在STE试验中，对于5%和0.05%的测试浓度，每个实验室预测未稀释原材料和稀释溶液（10%）眼刺激潜力的符合率均超过85%。最后，每个实验室通过STE试验预测模型进行等级分类的符合率超过72%，当从分析中排除酸、胺和醇时，符合率几乎达到90%。从上述数据可以看出，在两个实验室的实验室间研究中，STE试验具有出色的可转移性、较高的实验室间再现性和较高的预测能力。
