Korean Center for the Validation of Alternative Methods (KoCVAM), Nonclinical Resource Research Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, 28159, Republic of Korea.
Korean Center for the Validation of Alternative Methods (KoCVAM), Nonclinical Resource Research Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, 28159, Republic of Korea.
Food Chem Toxicol. 2024 Jun;188:114698. doi: 10.1016/j.fct.2024.114698. Epub 2024 Apr 26.
Phototoxicity is an acute toxic reaction induced by topical skin exposure to photoreactive chemicals followed by exposure to environmental light and thus chemicals that absorb UV are recommended to be evaluated for phototoxic potential. There are currently three internationally harmonized alternative test methods for phototoxicity. One of them is the in vitro Phototoxicity: RhE Phototoxicity test method (OECD TG498). Korean center for the Validation of Alternative Methods (KoCVAM) developed an in vitro phototoxicity test method using a KeraSkin™ reconstructed human epidermis model (KeraSkin™ Phototoxicity Assay) as a 'me-too' test method of OECD TG498. For the development and optimization of KeraSkin™ Phototoxicity Assay, the following test chemicals were used: 6 proficiency chemicals in OECD TG498 (3 phototoxic and 3 non-phototoxic), 6 reference chemicals in OECD Performance Standard No. 356 (excluding the proficiency test chemicals, 3 phototoxic and 3 non-phototoxic) and 13 additional chemicals (7 phototoxic and 6 non-phototoxic). Based on the test results generated from the test chemicals above, the overall predictive capacity of KeraSkin™ Phototoxicity Assay was calculated. In particular, the assay exhibited 100 % accuracy, 100 % sensitivity, and 100 % specificity. Therefore, it fulfills the requirements to be included as a 'me-too' test method in OECD TG498.
光毒性是一种由局部皮肤暴露于光反应性化学物质后再暴露于环境光引起的急性毒性反应，因此建议评估吸收紫外线的化学物质是否具有光毒性潜力。目前有三种国际协调一致的光毒性替代试验方法。其中之一是体外光毒性：人重组表皮光毒性试验方法（OECD TG498）。韩国替代方法验证中心（KoCVAM）开发了一种使用 KeraSkin™ 重建人表皮模型（KeraSkin™ 光毒性测定法）的体外光毒性试验方法，作为 OECD TG498 的“me-too”试验方法。为了开发和优化 KeraSkin™ 光毒性测定法，使用了以下试验化学品：OECD TG498 中的 6 种熟练化学品（3 种光毒性和 3 种非光毒性）、OECD 性能标准 No.356 中的 6 种参考化学品（不包括熟练测试化学品，3 种光毒性和 3 种非光毒性）和 13 种其他化学品（7 种光毒性和 6 种非光毒性）。基于上述测试化学品产生的测试结果，计算了 KeraSkin™ 光毒性测定法的总体预测能力。特别是，该测定法表现出 100%的准确性、100%的敏感性和 100%的特异性。因此，它满足了被纳入 OECD TG498 的“me-too”试验方法的要求。
