Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™).
Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™).
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DOI：
10.1016/j.tiv.2022.105515
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发表时间：
2023-02
期刊：
影响因子：
--
通讯作者：
Chan R
中科院分区：
文献类型：
--
作者：
Lebrun S;Chavez S;Nguyen L;Chan R
OptiSafe（OS）测试是货架稳定的大分子眼刺激测试，不包括任何动物成分或组分（“纯素”）。本研究的目的是评估原始和最近更新的OS方法在扩展应用领域的测试准确度。本研究涉及使用原始和更新的OS方法检测额外的眼部腐蚀剂和先前排除的发泡剂（“表面活性剂”），然后将这些数据与先前总共147种化学品的验证数据相结合。通过将OptiSafe预测与相同化学品的体内“Draize”兔眼历史数据（来自公共数据库）进行统计学比较，评价预测性。我们报告，对于不需要进行眼刺激分类的化学品[全球化学品统一分类和标签制度（GHS）无类别]的检测，更新方法的准确性、特异性和灵敏度分别为92.8%、79.6%和100.0%;对于检测导致极端眼损伤/腐蚀（GHS类别1）的化学品，更新方法的准确性、特异性和灵敏度分别为79.4%、71.8%和91.7%。结果表明，无论是原来的和更新的方法有很高的准确性扩展的应用领域，包括眼腐蚀剂和表面活性剂。
The OptiSafe (OS) test is shelf-stable, macromolecular eye irritation test that does not include any animal ingredient or component (“vegan”). The purpose of this study was to evaluate the test’s accuracy for an expanded application domain for both the original and recently updated OS method. This study involved the testing of additional ocular corrosives and previously excluded foaming agents (“surfactants”) using both the original and updated OS methods and then combining these data with prior validation data for a total of 147 chemicals. Predictivity was evaluated by a statistical comparison of the OptiSafe predictions with historical in vivo “Draize” rabbit eye data for the same chemicals (from public databases). We report that for the detection of chemicals not requiring classification for eye irritation [Globally Harmonized System of Classification and Labeling of Chemicals (GHS) No Category], the accuracy, specificity, and sensitivity were 92.8%, 79.6%, and 100.0%, respectively, for the updated method; for the detection of chemicals inducing extreme eye damage/corrosion (GHS Category 1), the accuracy, specificity, and sensitivity were 79.4%, 71.8%, and 91.7%, respectively, for the updated method. Results indicate that both the original and updated methods have a high accuracy for the expanded application domain that included ocular corrosives and surfactants.
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影响因子：
3.2
作者：
de Araujo Lowndes Viera, Luciana Madureira;Silva, Ronald Santos;Simoes Villas Boas, Maria Helena
通讯作者：
Simoes Villas Boas, Maria Helena
抗坏血酸特异性减少了OptISAFE™大分子眼刺激测试中非辐射反应性化学物质的错误分类。
影响因子：
3.2
作者：
Lebrun, Stewart;Chavez, Sara;Chan, Roxanne;Nguyen, Linda;Jester, James, V
通讯作者：
Jester, James, V
影响因子：
12.6
作者：
Hafner, F
通讯作者：
Hafner, F
影响因子：
3.2
作者：
Bagley, DM;Cerven, D;Harbell, J
通讯作者：
Harbell, J
影响因子：
3.2
作者：
Kandarova, H.;Letasiova, S.;Van Rompay, An R.
通讯作者：
Van Rompay, An R.