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.
Keywords: 3Rs; mouse; LD50; replacement; cell-based assay.