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首页> 外文期刊>Alternatives to laboratory animals: ATLA >Assessment of the skin irritation potential of chemicals by using the SkinEthic reconstructed human epidermal model and the common skin irritation protocol evaluated in the ECVAM skin irritation validation study.
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Assessment of the skin irritation potential of chemicals by using the SkinEthic reconstructed human epidermal model and the common skin irritation protocol evaluated in the ECVAM skin irritation validation study.

机译：通过使用SkinEthic重建的人表皮模型和在ECVAM皮肤刺激验证研究中评估的常见皮肤刺激方案，评估化学药品对皮肤的刺激潜力。

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Currently, two reconstructed human skin models, EpiDerm and EPISKIN are being evaluated in an ECVAM skin irritation validation study. A common skin irritation protocol has been developed, differing only in minor technical details for the two models. A small-scale study, applying this common skin irritation protocol to the SkinEthic reconstructed human epidermis (RHE), was performed at ZEBET at the BfR, Berlin, Germany, to consider whether this protocol could be successfully transferred to another epidermal model. Twenty substances from Phase III of the ECVAM prevalidation study on skin irritation were tested with the SkinEthic RHE. After minor, model-specific adaptations for the SkinEthic RHE, almost identical results to those obtained with the EpiDerm and EPISKIN models were achieved. The overall accuracy of the method was more than 80%, indicating a reliable prediction of the skin irritation potential of the tested chemicals when compared to in vivo rabbit data. As a next step, inter laboratory reproducibility was assessed in a study conducted between ZEBET and the Department of Experimental Toxicology, Schering AG, Berlin, Germany. Six coded substances were tested in both laboratories, with three different batches of the SkinEthic model. The assay results showed good reproducibility and correct predictions of the skin irritation potential for all six test chemicals. The results obtained with the SkinEthic RHE and the common protocol were reproducible in both phases, and the overall outcome is very similar to that of earlier studies with the EPISKIN and EpiDerm models. Therefore, the SkinEthic skin irritation assay test protocol can now be evaluated in a formal "catch-up" validation study.
机译：目前，正在ECVAM皮肤刺激性验证研究中评估两个重建的人类皮肤模型EpiDerm和EPISKIN。已经开发了一种常见的皮肤刺激方案，仅在两个模型的次要技术细节上有所不同。在德国柏林BfR的ZEBET中，进行了一项小规模研究，将这种常见的皮肤刺激方案应用于SkinEthic重建的人表皮（RHE），以考虑是否可以将该方案成功转移到另一种表皮模型上。使用SkinEthic RHE对ECVAM预验证研究第三阶段的20种皮肤刺激性物质进行了测试。在对SkinEthic RHE进行了针对模型的微小调整之后，获得了与EpiDerm和EPISKIN模型获得的结果几乎相同的结果。该方法的整体准确性超过80％，表明与体内兔数据相比，可以可靠地预测被测化学物质对皮肤的刺激潜力。下一步，在ZEBET和德国柏林先灵AG雅实验毒理学系之间进行的一项研究中评估了实验室间的可重复性。在两个实验室中测试了六种编码物质，并使用了三批不同的SkinEthic模型。该测定结果显示出良好的可重复性，并正确预测了所有六种测试化学品的皮肤刺激潜力。在两个阶段中，使用SkinEthic RHE和通用协议获得的结果都是可重复的，并且总体结果与早期使用EPISKIN和EpiDerm模型进行的研究非常相似。因此，现在可以在正式的“追赶”验证研究中评估SkinEthic皮肤刺激性试验测试规程。

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