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Abstract：
Several in vitro methods have gained regulatory acceptance for the prediction of skin irritation and corrosion. However, the test guidelines for the majority of in vitro methods do not state whether they are applicable to agrochemical formulations. Hence, we would like to share the results from our routine skin corrosion and irritation testing of agrochemical formulations in which both in vitro (according to OECD TG 431 and OECD TG 439) and in vivo (according to OECD TG 404) tests were conducted as regulatory requirements. The in vitro skin irritation test did not correlate well with the CLP classification by in vivo results (44% sensitivity, 60% specificity, and 54% accuracy, based on 65 data pairs). This indicates a lack of applicability of the current protocol of the in vitro skin irritation test for agrochemical formulations. The data set did not contain formulations which were skin corrosive in vivo and hence its applicability could not be assessed. The correlation of in vitro skin corrosion testing to formulations which were not corrosive in vivo was, however, high (95% specificity based on 81 data pairs).
摘要：
几种体外方法已经获得了用于预测皮肤刺激和腐蚀的监管认可。然而,大多数体外方法的测试指南没有说明它们是否适用于农用化学品制剂。因此，我们想分享我们对农用化学品制剂的常规皮肤腐蚀和刺激测试的结果,其中体外(根据OECDTG431和OECDTG439)和体内(根据OECDTG404)测试均作为监管要求进行.通过体内结果，体外皮肤刺激试验与CLP分类没有很好的相关性(44%的灵敏度，60%特异性,准确率为54%,基于65个数据对)。这表明目前的体外皮肤刺激试验方案对农业化学制剂缺乏适用性。数据集不含在体内具有皮肤腐蚀性的制剂,因此不能评估其适用性。体外皮肤腐蚀测试与体内无腐蚀性制剂的相关性为，然而,高（基于81个数据对的95%特异性）。
