Highly invasive animal based test procedures for risk assessment such as the Draize eye test are under increasing criticism due to poor transferability for the human organism and animal-welfare concerns. However, besides all efforts, the Draize eye test is still not completely replaced by alternative animal-free methods. To develop an in vitro test to identify all categories of eye irritation, we combined organotypic cornea models based on primary human cells with an electrical readout system that measures the impedance of the test models. First, we showed that employing a primary human cornea epithelial cell based model is advantageous in native marker expression to the primary human epidermal keratinocytes derived models. Secondly, by employing a non-destructive measuring system based on impedance spectroscopy, we could increase the sensitivity of the test system. Thereby, all globally harmonized systems categories of eye irritation could be identified by repeated measurements over a period of 7 days. Based on a novel prediction model we achieved an accuracy of 78% with a reproducibility of 88.9% to determine all three categories of eye irritation in one single test. This could pave the way according to the 3R principle to replace the Draize eye test.

中文翻译：

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替代Draize眼部测试：阻抗光谱法是一种3R方法，用于区分所有GHS类别的眼睛刺激性。

由于对人体的可移植性差以及对动物福利的关注，用于风险评估的基于高侵入性动物的测试程序（例如Draize眼部测试）受到越来越多的批评。但是，除了所有努力之外，Draize眼部检查仍不能完全由其他无动物方法替代。为了开发一种体外测试以识别所有种类的眼睛刺激，我们将基于人类原代细胞的器官型角膜模型与测量该模型阻抗的电读出系统相结合。首先，我们表明采用基于人类角膜上皮细胞的原始模型在天然标记表达方面比人类原始表皮角质形成细胞的模型更具优势。其次，通过采用基于阻抗谱的无损测量系统，我们可以提高测试系统的灵敏度。因此，可以通过在7天内重复测量来识别所有全球统一的眼刺激系统类别。基于一种新颖的预测模型，我们在一次测试中确定所有三类眼刺激的准确性达到了78％，可重复性达到88.9％。这可以根据3R原理为取代Draize眼力测试铺平道路。