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Botulinum toxin testing on animals is still a Europe-wide issue.

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New cell-based assays are replacing the mouse bioassay for Botulinum toxin A batch testing in Europe. Despite this progress, overall animal use in these tests remains high, prompting calls for further reductions in animal testing.

Keywords:
3RsmouseLD50replacementcell-based assay

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Area of Science:

  • Toxicology
  • In vitro methods
  • Animal welfare science

Background:

  • Significant advancements in animal testing alternatives for Botulinum toxin products in Europe.
  • Animal protection organizations critically review these developments.
  • Existing regulations like EU Directive 2010/63 guide animal use in scientific purposes.

Purpose of the Study:

  • To summarize and discuss recent developments in animal testing for Botulinum toxin products in Europe from an animal protection perspective.
  • To evaluate the impact of validated cell-based assays on animal usage.
  • To address concerns regarding animal testing for aesthetic Botulinum toxin products and ongoing regulatory permissions.

Main Methods:

  • Review of validated cell-based assays replacing the traditional mouse bioassay for Botulinum toxin A batch testing.
  • Analysis of official statistics and non-technical summaries on animal usage in Europe.
  • Discussion of regulatory frameworks and ethical considerations for animal testing.

Main Results:

  • Allergan, Merz, and Ipsen have validated cell-based assays to replace the mouse bioassay for Botulinum toxin A batch testing.
  • An estimated 400,000 animals are used annually for batch tests in Europe, indicating record high levels.
  • Concerns persist regarding the authorization of animal testing for aesthetic Botulinum toxin products.

Conclusions:

  • While cell-based assays offer a promising alternative to the mouse bioassay for Botulinum toxin A potency testing, overall animal use remains high.
  • There is a critical need for a real-term reduction in animal testing across Europe.
  • Continued evaluation of regulatory permissions for animal testing, especially for aesthetic purposes, is essential.