Sauer Ursula G
Akademie fuer Tierschutz, D-Neubiberg.
ALTEX. 2005;22(1):19-24.
Since bivalve molluscs can contain algae biotoxins that can cause gastroenterological or even lethal neurological diseases in humans, a public health control system on marine biotoxins has been implemented in EU Directive 91/492. Currently, the reference method laid down for this purpose is the so-called "mouse bioassay" with death of the animals as an endpoint. To date, this extremely distressful animal test has not been standardised or validated, and there is scientific evidence that it is neither relevant nor reliable. Therefore different EU Member States have been striving to replace the mouse bioassay or to reduce the animal numbers and the distress for the animals. In the United Kingdom, the test is being performed with two instead of three mice, the animals are anaesthetised before injection of the mollusc extract and remain in narcosis until their death. In Germany the mouse bioassay has not been performed for many years; without restriction of consumer health safety, marine biotoxins are detected with chemical analytical test methods. The application of alternative test methods is legally required according to EU Directive 86/609 on the Protection of Laboratory Animals. Apparently there is a conflict between two equal valid EU Directives, which has to be overcome.
由于双壳贝类可能含有藻类生物毒素，会导致人类出现胃肠疾病甚至致命的神经疾病，欧盟第91/492号指令实施了海洋生物毒素公共卫生控制系统。目前，为此规定的参考方法是所谓的“小鼠生物测定法”，以动物死亡作为终点。迄今为止，这种极其痛苦的动物试验尚未标准化或得到验证，而且有科学证据表明它既不相关也不可靠。因此，不同的欧盟成员国一直在努力取代小鼠生物测定法，或减少动物数量以及动物的痛苦。在英国，试验用两只而非三只小鼠进行，在注射贝类提取物之前对动物进行麻醉，并使其一直处于麻醉状态直至死亡。在德国，小鼠生物测定法已经多年未进行；在不限制消费者健康安全的情况下，使用化学分析测试方法检测海洋生物毒素。根据欧盟关于保护实验动物的第86/609号指令，法律要求应用替代测试方法。显然，两项同样有效的欧盟指令之间存在冲突，必须加以克服。
