Abstract:
The OECD has approved two similar methods for testing the phototoxic potency of chemicals. The first method, OECD 432, is based on the cytotoxicity properties of materials to the mouse 3T3 (clone A31) cell line (fibroblasts) after exposure to light. The second method, OECD 498, is based on the same properties but using reconstructed human epidermis - EpiDerm (stratified keratinocytes). The aim of this study was to compare these two methods using statistical tests (specificity, sensitivity, negative predictive value, positive predictive value and accuracy) and non-statistical characteristics (e.g. price and experimental duration, amount of material, level of complications, cell type, irradiation dose). Both tests were performed according to the relevant guidelines using the same 11 control substances. Higher performance values were observed for OECD 432 in both phototoxic and non-phototoxic classifications. The accuracy of OECD 432 was 90.9%, while that of OECD 498 was 72.7%. OECD 432 was also shorter and less expensive. On the other hand, OECD 498 was less complicated, and used human cells with stratum corneum, which better reflects real skin. This method can also be used with oily substances that are poorly soluble in water. However, both methods are important for testing the phototoxic properties of materials, and can be used alone or in a tiered strategy.
摘要:
经合组织已经批准了两种类似的方法来测试化学品的光毒性效力。第一种方法,OECD432基于暴露于光后材料对小鼠3T3(克隆A31)细胞系(成纤维细胞)的细胞毒性特性。第二种方法,OECD498基于相同的特性,但使用重建的人表皮-EpiDerm(分层角质形成细胞)。本研究的目的是使用统计检验(特异性,灵敏度,负预测值,正预测值和准确性)和非统计特征(例如价格和实验持续时间,材料量,并发症的水平,细胞类型,辐照剂量)。两种测试均根据相关指南使用相同的11种对照物质进行。在光毒性和非光毒性分类中,OECD432的性能值均较高。OECD432的准确度为90.9%,OECD498为72.7%。OECD432也更短,更便宜。另一方面,OECD498没有那么复杂,用人类角质层细胞,更好地反映真实的皮肤。该方法也可用于难溶于水的油性物质。然而,这两种方法对于测试材料的光毒性都很重要,并且可以单独使用或在分层策略中使用。