European Coalition to End Animal Experiments, London, UK.
ALTEX. 2019;36(1):81-90. doi: 10.14573/altex.1807101. Epub 2018 Oct 10.
There have been significant developments in the use of animals to test Botulinum toxin products in Europe in recent years. This paper summarises and discusses these from the perspective of the animal protection organisation. A cell-based assay has been validated by Allergan and is now being used for the replacement of the mouse bioassay for the batch testing of their Botulinum toxin A products. Two further companies (Merz and Ipsen) have recently validated similar cell-based assays to replace animals in their batch testing. However, the number of animals being used in batch tests across Europe remains at record levels; an estimated 400,000 animals per year, based on official statistics and non-technical summaries. There are concerns from animal protection organisations about the authorisation of animal testing for Botulinum toxin products that are to be used for aesthetic purposes. Furthermore, should testing for companies that have not yet implemented the alternative method continue to be permitted under the EU Directive 2010/63 on the use of animals for scientific purposes? Whilst we are on the cusp of an era where the mouse bioassay has been replaced for the potency testing of Botulinum toxin A for injection, it is important that Europe sees a reduction of animal testing in real terms.
近年来，在欧洲，人们在动物身上测试肉毒毒素产品方面取得了重大进展。本文从动物保护组织的角度对这些进展进行了总结和讨论。Allergan 已经验证了一种基于细胞的检测方法，目前正在用于替代小鼠生物测定法，以对其肉毒毒素 A 产品进行批量测试。另外两家公司（Merz 和 Ipsen）最近也验证了类似的基于细胞的检测方法，以替代动物进行批量测试。然而，欧洲的批量测试中使用的动物数量仍然保持在创纪录的水平；根据官方统计数据和非技术性摘要，每年约有 40 万只动物。动物保护组织对出于美容目的而批准对肉毒毒素产品进行动物测试表示担忧。此外，对于尚未采用替代方法的公司，欧盟关于在科学用途中使用动物的指令 2010/63 是否应继续允许进行测试？虽然我们正处在一个时代的边缘，即小鼠生物测定法已被用于注射用肉毒毒素 A 的效力测试所取代，但欧洲确实需要减少实际的动物测试。
