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肉毒神经毒素 LD50 测试——问题与解决方案。

The botulinum neurotoxin LD50 test - problems and solutions.

出版信息

ALTEX. 2010;27(2):114-6. doi: 10.14573/altex.2010.2.114.

DOI:10.14573/altex.2010.2.114
PMID:20686744
Abstract

Apart from the fact that the LD50 test is generally considered a procedure causing severe distress, which alone should result in its immediate deletion, it also conflicts with the EU wide ban on cosmetic testing in animals in the case of Botulinum Neurotoxin (BoNT) testing. The European Pharmacopoeia monograph allows for the use of three alternative methods provided they are validated. However these alternative assays are neither implemented by the manufactures of BoNT products nor are they enforced by the responsible authorities, e.g. by deleting the LD50 from the European Pharmacopoeia. The number of animals used for the testing of BoNT is not officially recorded. However, data from an undercover investigation allow the estimation that the number of mice used in LD50tests for BoNT products is greater than 600,000 per year worldwide.

摘要

除了 LD50 测试通常被认为是一种会引起严重不适的程序,仅凭这一点就应该立即禁止使用之外,它还与欧盟范围内禁止在动物身上进行肉毒杆菌神经毒素 (BoNT) 测试的规定相冲突。《欧洲药典》专论允许使用三种替代方法,只要这些方法得到验证。然而,这些替代检测方法既没有被 BoNT 产品的制造商采用,也没有被主管当局强制执行,例如将 LD50 从《欧洲药典》中删除。用于 BoNT 测试的动物数量并未得到官方记录。然而,一项卧底调查的数据允许估计,全球每年用于 BoNT 产品 LD50 测试的老鼠数量超过 60 万只。

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