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首页> 外文期刊>Journal of applied toxicology >A catch-up validation study of an in vitro skin irritation test method using reconstructed human epidermis LabCyte EPI-MODEL24
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A catch-up validation study of an in vitro skin irritation test method using reconstructed human epidermis LabCyte EPI-MODEL24

机译：使用重组人表皮LabCyte EPI-MODEL24进行体外皮肤刺激性测试方法的追赶性验证研究

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Three validation studies were conducted by the Japanese Society for Alternatives to Animal Experiments in order to assess the performance of a skin irritation assay using reconstructed human epidermis (RhE) LabCyte EPI-MODEL24 (LabCyte EPI-MODEL24 SIT) developed by the Japan Tissue Engineering Co., Ltd. (J-TEC), and the results of these studies were submitted to the Organisation for Economic Co-operation and Development (OECD) for the creation of a Test Guideline (TG). In the summary review report from the OECD, the peer review panel indicated the need to resolve an issue regarding the misclassification of 1-bromohexane. To this end, a rinsing operation intended to remove exposed chemicals was reviewed and the standard operating procedure (SOP) revised by J-TEC. Thereafter, in order to confirm general versatility of the revised SOP, a new validation management team was organized by the Japanese Center for the Validation of Alternative Methods (JaCVAM) to undertake a catch-up validation study that would compare the revised assay with similar in vitro skin irritation assays, per OECD TG No. 439 (2010). The catch-up validation and supplementary studies for LabCyte EPI-MODEL24 SIT using the revised SOPs were conducted at three laboratories. These results showed that the revised SOP of LabCyte EPI-MODEL24 SIT conformed more accurately to the classifications for skin irritation under the United Nations Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS), thereby highlighting the importance of an optimized rinsing operation for the removal of exposed chemicals in obtaining consistent results from in vitro skin irritation assays.
机译：日本动物实验替代学会进行了三项验证研究，以评估由日本组织工程公司开发的重建人表皮（RhE）LabCyte EPI-MODEL24（LabCyte EPI-MODEL24 SIT）的皮肤刺激试验的性能。 （J-TEC），并将这些研究的结果提交给经济合作与发展组织（OECD），以创建测试指南（TG）。在经合组织的简要审查报告中，同行审查小组指出有必要解决有关1-溴己烷分类错误的问题。为此，J-TEC审查了旨在去除暴露的化学物质的漂洗操作，并修订了标准操作程序（SOP）。此后，为了确认修订版SOP的通用性，日本替代方法验证中心（JaCVAM）组建了一个新的验证管理团队，以进行追赶性验证研究，该研究将修改后的测定与类似方法进行比较。根据OECD TG No.439（2010）进行的体外皮肤刺激试验。在三个实验室中使用修订后的SOP对LabCyte EPI-MODEL24 SIT进行了追赶验证和补充研究。这些结果表明，经过修订的LabCyte EPI-MODEL24 SIT的SOP更准确地符合联合国化学品全球分类和标签协调制度（UN GHS）下的皮肤刺激性分类，从而凸显了优化漂洗操作的重要性去除暴露的化学物质，以从体外皮肤刺激试验中获得一致的结果。

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