Definition of the Applicability Domain of the Short Time Exposure (STE) Test for Predicting the Eye Irritation of Chemicals
Definition of the Applicability Domain of the Short Time Exposure (STE) Test for Predicting the Eye Irritation of Chemicals
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DOI：
10.1177/026119291304100205
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发表时间：
2013-05-01
影响因子：
2.7
通讯作者：
Sakaguchi, Hitoshi
中科院分区：
文献类型：
--
作者：
Hayashi, Kazuhiko;Abo, Takayuki;Sakaguchi, Hitoshi
短时暴露(STE)试验是一种简单、易于进行的体外眼刺激试验，它以SIRC细胞(一种兔角膜细胞系)处理5分钟后的活性为终点。在这项研究中，我们的目标是定义STE测试的适用范围，基于对113种物质的测试结果。为了实现这一目标，根据全球协调制度(GHS)，选择了代表不同化学类别和不同化学特性的化学品，并以平衡的方式涵盖了眼睛刺激潜力的类别。准确度分析表明，有机/无机盐(75.0%)、烃类(33.3%)和醇类(23.5%)的假阴性率较高。许多假阴性结果是针对固体物质的。值得注意的是，在STE试验中，没有表面活性剂导致假阴性结果。对物理性质数据和性能的进一步检查表明，当分析中排除蒸汽压力超过6kPa的物质时，预测准确性有了显著提高。我们的结果表明，有几种物质--即某些固体，如盐、醇、碳氢化合物和蒸气压力超过6kPa的挥发性物质--不属于STE测试的适用范围。总体而言，我们对STE测试的性能和提高的准确性感到鼓舞。
The Short Time Exposure (STE) test is a simple and easy-to-perform in vitro eye irritation test, that uses the viability of SIRC cells (a rabbit corneal cell line) treated for five minutes as the endpoint. In this study, our goal was to define the applicability domain of the STE test, based on the results obtained with a set of 113 substances. To achieve this goal, chemicals were selected to represent both different chemical classes and different chemical properties, as well as to cover, in a balanced manner, the categories of eye irritation potential according to the Globally Harmonised System (GHS). Accuracy analysis indicated that the rates of false negatives for organic/inorganic salts (75.0%), hydrocarbons (33.3%) and alcohols (23.5%) were high. Many of the false negative results were for solid substances. It is noteworthy that no surfactant resulted in a false negative result in the STE test. Further examination of the physical property data and performance showed a significant improvement in the predictive accuracy, when substances with vapour pressures over 6kPa were excluded from the analyses. Our results indicate that several substances - i.e. certain solids such as salts, alcohols, hydrocarbons, and volatile substances with a vapour pressure over 6kPa - do not fall within the applicability domain of the STE test. Overall, we are encouraged by the performance and improved accuracy of the STE test.