Prediction models for eye irritation potential based on endpoints of the HETCAM and neutral red uptake tests.

Andrew Paul Worth, M. Cronin
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引用次数: 14

Abstract

The aim of this study was to explore the possibility of distinguishing between eye irritants (I; EU risk phrases R36 and R41) and nonirritants (NI), by using in vitro endpoints of the hen's egg test on the chorioallantoic membrane (the HETCAM test) and the neutral red uptake (NRU) test. Prediction models were derived by applying binary logistic regression to the in vitro data for these endpoints, which were taken from the report of a German validation study on the use of the HETCAM and 3T3 NRU tests as alternatives to the Draize eye irritation test. Whereas the validation study led to the conclusion that the combined use of the two tests enables a satisfactory discrimination between severe (R41) and nonsevere (NI, R36) eye irritants, the results of the present study indicate that the two in vitro tests can also be used to discriminate between nonirritants (NI) and irritants (R36 and R41).
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基于HETCAM和中性红色摄取试验终点的眼睛刺激电位预测模型。
本研究的目的是探讨区分眼睛刺激物的可能性(I;欧盟风险期R36和R41)和非刺激物(NI),通过使用体外终点的鸡蛋试验在绒毛膜尿囊膜(HETCAM试验)和中性红色摄取(NRU)试验。预测模型是通过对这些终点的体外数据应用二元逻辑回归得出的,这些终点来自德国一项关于使用HETCAM和3T3 NRU测试替代Draize眼睛刺激测试的验证研究报告。虽然验证研究得出结论,联合使用这两种测试可以令人满意地区分严重(R41)和非严重(NI, R36)的眼睛刺激,但本研究的结果表明,这两种体外测试也可以用于区分非刺激物(NI)和刺激物(R36和R41)。
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