Growing Old Disgracefully: The Cosmetic Use of Botulinum Toxin

Abstract

The explosive growth in the use of botulinum toxin for cosmetic purposes has undoubtedly had an impact on the number of animals used in the potency testing of this product. The test used is a classical LD50, a severe procedure during which animals experience increasing paralysis until the occurrence of death. The enthusiastic adoption by the general public of the use of botulinum toxin as an anti-wrinkle treatment has, at least in Europe, paradoxically taken place against a background of moves to stop animal testing of cosmetics and cosmetic ingredients. There appears to be a dearth of information aimed at the public concerning botulinum toxin testing. Botulinum toxin does have important medical applications; however, the question arises whether a blanket licence for the testing can be justified, when a large proportion of the product is being used cosmetically. A further question is why death continues to be the endpoint of the potency test, when a more-humane endpoint has been proposed. In addition, a number of alternative methods have been developed, which could have the potential to replace the lethal potency test altogether. These methods are discussed in this paper, and the importance of establishing a strategy for their validation is emphasised, a need that has become even more urgent in the light of the recently published draft monograph on botulinum toxin by the European Pharmacopoeia Commission.

Trends in Animal Use and Replacement in the ‘Three Is’ of Industry

“…Interestingly, the 10-year time-frame required by Allergan to develop the in vitro assay coincides with the 10-year botulinum toxin testing campaign waged by The Humane Society of the United States and FRAME. 2 Based on examples such as this, it seems likely that consumer pressure, coupled with innovative technologies, will continue to drive the development, validation and implementation of non-animal replacements in relation to cosmetic ingredients and products.…”

What Price Vanity? No End in Sight for the Cosmetics Testing Saga

“…As Krys Bottrill 1 The consequences for laboratory animal welfare of the increasingly avid use by fading celebrities and the general public of botulinum toxin as an antiwrinkle treatment have attracted very little attention, not only from the media (which does not surprise me), but also from organisations campaigning to stop animal testing for cosmetic purposes (which does).…”

“…Even in this case, which involves the use of one of the most powerful poisons known, the Three Rs could be much more effectively applied. 1 It is particularly important to recognise that scientifically sound replacement alternative testing strategies are already known to be feasible, though urgently in need of further development and validation. I very much hope that Krys Bottrill's article will lead to the necessary action, with the full support of the Government.…”

The Botulinum Toxin LD50 Potency Assay — Another Chapter, Another Mystery

“…3 A replacement for the MLA has been looked for over many years and written about often. 9 Contrary to what has been written in many cases, there were no 'alternatives' to use as substitutes, since these were either not sufficiently sensitive, not validated against the MLA, or both. 10 Despite this situation, which has been clearly documented, the calls for a replacement have often been made.…”

“…10 Despite this situation, which has been clearly documented, the calls for a replacement have often been made. 2,3,9 Much activity has been undertaken on suitable replacements, together with the refinement or reduction of the method called for by the Three Rs approach. 10 Refinement and reduction have both played important, and often overlooked, roles in reducing mouse use in the MLA, yet, these aspects are hardly ever reported.…”