Schlede E, Mischke U, Roll R, Kayser D
Abteilung Chemikalienbewertung, Max von Pettenkofer-Institut, Berlin, Federal Republic of Germany.
Arch Toxicol. 1992;66(7):455-70. doi: 10.1007/BF01970670.
In a national collaborative study an alternative to the classical LD50 test--the acute-toxic-class method--was validated. With this testing procedure mortality ranges are determined between defined dose levels that are used for classification and labelling in the European Community. The results were compared with LD50 data obtained from the literature which were categorized according to the defined dose levels. The results of this collaborative study have shown that the acute-toxic-class method allows allocation to the toxicity classes of very toxic, toxic, harmful and unclassified in the same manner as on the basis of the classical LD50 tests. The acute-toxic-class method uses fewer animals and subjects fewer animals to pain and distress than the LD50 test and yields the same information on toxic signs in the treated animals. Identical classifications were obtained by the six participating laboratories in 86% of the tests. This demonstrates that the acute-toxic-class method results in excellent reproducibility in comparison to the classical LD50 test and that this new method is a reliable alternative to the LD50 test.
在一项全国性合作研究中，一种替代经典半数致死量（LD50）试验的方法——急性毒性分级法——得到了验证。通过这种测试程序，可确定欧洲共同体用于分类和标签的特定剂量水平之间的死亡率范围。将结果与从文献中获得的LD50数据进行比较，这些数据是根据特定剂量水平分类的。这项合作研究的结果表明，急性毒性分级法能够以与基于经典LD50试验相同的方式将物质归入剧毒、有毒、有害和未分类的毒性类别。与LD50试验相比，急性毒性分级法使用的动物数量更少，使动物遭受疼痛和痛苦的数量也更少，并且能提供关于受试动物中毒迹象的相同信息。六个参与实验室在86%的测试中获得了相同的分类结果。这表明，与经典LD50试验相比，急性毒性分级法具有出色的重现性，并且这种新方法是LD50试验的可靠替代方法。
