Anti-animal testing group attacks ‘cruel’ botox tests
Despite a European ban on the use of animals for the testing of cosmetic products, BUAV chief executive, Michelle Thew, told CosmeticsDesign-Europe.com a loophole in the law allows animals to continue to ‘suffer dreadfully’ in tests for botox products that, although licensed for medical use, could end up being used, legally, for cosmetic use.
“We are concerned that the public is being misled about claims that animals are not used to test products that are used for cosmetic purposes.”
Controversy over the LD50 test
The Lethal Dose 50% (LD50) is a toxicity test which is currently used to test botox, and involves injecting mice with the botulinum toxin.
Thew said many organizations neglect to observe the tests competently and allowed mice to suffer and die describing the test as “an archaic and cruel test, literally requiring animals to die in order to determine the safety of a product.”
However, manufacturer Ipsen told CosmeticsDesign-Europe.com how the mouse LD50 potency assay is the only method approved by regulatory authorities anywhere in the world.
“No regulatory authority anywhere in the world will grant approval for a company to substitute the LD50 for an alternative assay, whether animal-based or not, unless they are entirely satisfied that the alternative is valid, meets the requirements laid down in national and international guidelines for validity and is comparable with the current LD50 method,” an Ipsen spokesperson said.
Ipsen stressed that finding an alternative test and getting it validated requires a high degree of science and relevance, although it has been intensively searching for alternatives to animal testing and will continue to do so.
Introducing alternative methods of testing
BUAV states companies have a legal obligation under EU legislation not to use animals when alternative methods could be used instead. One such test could be the SNAP-25, it claims.
This endopeptidase assay is a non animal method, and measures the activity of the toxin in a test tube. The National Institute for Biological Standards and Control has validated this test and been using it to test Ipsen’s botulinum product, Dysport, since 1999.
However, Ipsen highlights that the SNAP-25 has never been accepted for product quality testing and release by any worldwide regulatory authority, since it only measures one property of botulinum toxin and is an internal method.
According to Ipsen, although used by and adequately established for their own purposes, this method has also not been validated in accordance with the requirements of the European Pharmacopoeia, regulatory authorities worldwide or the ICH guidelines.
Working on a replacement
Ipsen is one of many manufacturers who have joined scientists and regulatory authorities in the European Expert Working Group. One purpose is to develop a replacement for the mouse LD50 test, and this collaboration is the most appropriate route ahead ensuring the safety and efficacy required by both company and authority, according to an Ipsen spokesperson.
“The industry and scientists have made progress in implementing reduction and refinement in BoNT [Botulinum Neurotoxin] potency testing, and in the development of alternative potency assays.”
Thew maintains there are already alternatives, and state it is the Home Office’s obligation not to license tests, such as the LD50, when an alternative is available.
“It is morally unacceptable that animals should be made to suffer so severely for a product that is predominantly used for aesthetic (cosmetic) purposes and in a test that is eminently replaceable.”
BUAV believes the manufacturers of botulinum neurotoxin type A complex are being disingenuous when they talk about the uses of their products, and whilst botox undoubtedly has medical uses, its main use is for cosmetic purposes, most notably to remove frown lines and wrinkles.
