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利用基于 Hansen 溶解度参数计算的人眼角膜上皮模型的潜在参数来预测眼部刺激的替代指标。

An alternative predictor of eye irritation that utilizes potential parameters of the human corneal epithelium model calculated based on Hansen solubility parameters.

机构信息

Department of Chemical, Energy and Environmental Engineering, Faculty of Environmental and Urban Engineering, Kansai University, Japan.

Department of Chemical, Energy and Environmental Engineering, Faculty of Environmental and Urban Engineering, Kansai University, Japan; Development Headquarters, Milbon Co. Ltd., Japan.

出版信息

Toxicol Lett. 2021 May 15;342:1-5. doi: 10.1016/j.toxlet.2021.01.019. Epub 2021 Feb 2.

Abstract

Eye irritation predictions are very important in the development of cosmetics and pharmaceuticals. For animal protection, alternative tests are being developed to replace the Draize test, which involves the use of rabbits to test eye irritation. The Vitrigel-eye irritancy test (Vitrigel-EIT), is one such alternative. As a preliminary study, we evaluated if Hansen solubility parameter (HSP) values can be used to predict Vitrigel-EIT results. An Hansen sphere was created based on the HSP values and Vitrigel-EIT results from 61 substances. Substances inside and outside of the sphere were designated as dangerous and safe substances, respectively. The safety of each test substance was predicted by comparing the center point (R) of the sphere with the relative energy difference, i.e., the ratio of each test substance (R). The accuracy, false negativity, and false positivity of the "irritant" and "nonirritant" designations, as determined by the Vitrigel-EIT results and Hansen sphere, were 91.8% (56/61), 2.3% (1/43), and 22.2% (4/18), respectively. These results indicated that HSP values can be used to predict Vitrigel-EIT results with high reproducibility, and thus are useful for evaluating the safety of substances.

摘要

眼睛刺激预测在化妆品和药品的开发中非常重要。为了保护动物,正在开发替代试验来替代Draize 试验,该试验涉及使用兔子来测试眼睛刺激。Vitrigel 眼刺激性试验(Vitrigel-EIT)就是这样的一种替代方法。作为初步研究,我们评估了汉森溶解度参数(HSP)值是否可用于预测 Vitrigel-EIT 结果。根据 HSP 值和 61 种物质的 Vitrigel-EIT 结果创建了汉森球体。球体内部和外部的物质分别被指定为危险物质和安全物质。通过将球体的中心点(R)与相对能量差(即每种测试物质的比率)进行比较,预测了每种测试物质的安全性。根据 Vitrigel-EIT 结果和汉森球体的结果,“刺激性”和“非刺激性”指定的准确性、假阴性和假阳性率分别为 91.8%(56/61)、2.3%(1/43)和 22.2%(4/18)。这些结果表明,HSP 值可用于预测 Vitrigel-EIT 结果,具有很高的重现性,因此可用于评估物质的安全性。

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