L'Oréal Research & Innovation, Aulnay-Sous-Bois, France.
NIKKOL Group, Cosmos Technical Center Co., Ltd, Tokyo, Japan.
Toxicol In Vitro. 2019 Feb;54:202-214. doi: 10.1016/j.tiv.2018.10.003. Epub 2018 Oct 4.
Assessment of ocular irritation risk is an international regulatory requirement in the safety evaluation of products. In response to this need, L'Oréal developed the SkinEthic™ Human Corneal Epithelium (HCE) Eye Irritation Test (EIT) that has been included in OECD Test Guideline 492. SkinEthic™ HCE EIT is able to correctly and reliably identify chemicals not requiring classification versus labelling for eye irritation or serious eye damage according to UN GHS. In an effort to promote its global use, the performance of the method was evaluated after long-distance shipment and compared to European shipment conditions. Results obtained by Cosmos Technical Center (Japan) after extended tissues transit were compared to results obtained in L'Oréal (France). Thirty-nine out of 40 blinded chemicals, representing different functional chemical classes, were consistently classified in both laboratories. The SkinEthic™ HCE EIT test method was also evaluated for its performance after extended storage of the tissues. The performance was in agreement with the values reported in OECD TG 492, with an overall accuracy of 87.1% (based on 119 chemicals), sensitivity of 95.5% and specificity of 73.5%. The reliability and relevance of SkinEthic™ HCE EIT test method after long-distance shipment and extended storage remain in agreement with regulatory validation criteria.
眼刺激风险评估是产品安全评估中的国际监管要求。针对这一需求，欧莱雅开发了 SkinEthic™ 人角膜上皮（HCE）眼刺激试验（EIT），该试验已被纳入 OECD 测试指南 492。SkinEthic™ HCE EIT 能够根据联合国全球化学品统一分类和标签制度（UN GHS）正确可靠地识别不需要分类或标签的眼刺激或严重眼损伤的化学品。为了促进其在全球范围内的使用，在长途运输后评估了该方法的性能，并与欧洲运输条件进行了比较。在经过长时间的组织运输后，由 Cosmos 技术中心（日本）获得的结果与在欧莱雅（法国）获得的结果进行了比较。在两个实验室中，代表不同功能化学类别的 40 种盲测化学品中有 39 种被一致分类。还评估了 SkinEthic™ HCE EIT 试验方法在组织长时间储存后的性能。该性能与 OECD TG 492 中报告的值一致，总准确率为 87.1%（基于 119 种化学品），灵敏度为 95.5%，特异性为 73.5%。长途运输和长时间储存后 SkinEthic™ HCE EIT 试验方法的可靠性和相关性仍符合监管验证标准。
