Animal Aid

BOTOX AND ANIMAL EXPERIMENTS - Testing 'anti-wrinkle' injections

Thousands of mice are being poisoned to death to test the latest cosmetic craze: 'Botox'. In barbaric experiments known as LD50 toxicity tests - supposedly outlawed by the government in 1999 - the animals are injected with the toxin and suffer symptoms including impaired vision, paralysis of the body, and paralysis of the diaphragm, which leads to death by suffocation.

Following a rapid decrease in the overall number of LD50 tests in recent years, numbers are reported to have risen significantly over the last two years in line with the surge in popularity of botox injections. Apart from the devastating impact on the animal victims, the LD50 test is also a betrayal of people who imagine that botox cosmetic treatments have undergone proper safety tests. This is not the case.

The LD50 is now widely recognised in scientific and industry circles as being crude and unreliable. Given the highly toxic nature of botulinum, it is especially important that the substance is assessed in a scientific and dependable manner.

A battery of non-animal tests are already in existence which could, and should, immediately replace the animal-poisoning experiments.

Celebrity endorsement

Botox is the name given to botulinum toxin when used for cosmetic purposes. By paralysing the muscles, it makes it impossible to frown or crease the skin - hence making wrinkles 'disappear'. Botox injections are becoming increasingly popular as a cosmetic procedure, being popularised in no small measure thanks to celebrity endorsement. As well as its 'wrinkle-busting powers', botox has - apparently - been used by celebrities to paralyse the sweat glands under their arms, and thereby stop perspiration!

Biological weapon potential

Botulinum is considered to be more toxic to humans than most other known substances (it has biological weapon potential!). Its primary use is medical, in the treatment of various human conditions, including squints, involuntary twitches and facial spasms, with another 50 therapeutic applications currently being investigated. Cosmetic use, however, is the area that is growing the most rapidly. In the USA, it has been approved for medical reasons since 1989 and for cosmetic purposes since 2002. In the UK, it is also administered for both purposes, although it is not yet licensed for cosmetic use. The cosmetic application of botox, therefore, is categorised as 'off label', meaning that it is used at the discretion of the physician carrying out the procedure - and it is he or she who must take full personal responsibility for its safety, efficacy and quality. A UK-based company, called Dysport, has applied to the US Food and Drug Administration for a licence to market its own cosmetic brand of botox. If the licence is granted, the company will be able to advertise Dysport as a cosmetic product. This will inevitably lead to an even more significant increase in use.

Blanket licences

The potency of botulinum will vary from batch to batch. Before going on sale - whether for cosmetic or medical purposes - each batch will have gone through safety testing to assess its strength and toxicity. The Home Office supposedly no longer issues licences for testing cosmetic products on animals, as it does for pharmaceutical products. But because blanket licences are granted for botox toxicity testing, and no distinction is made between batches destined for the cosmetic as opposed to the pharmaceutical sector, it is all produced, and 'safety-tested' in the same way.

After potency testing on each batch by the manufacturers, a further confirmatory potency test is performed at one or more laboratories in the countries in which the batch will be used.

Mice suffocated to death

The potency test currently in use is the LD50 poisoning test. Acknowledged by the UK government to be a 'severe procedure', groups of mice are injected with various dilutions of toxin from a single batch to determine the dose that will kill half the mice in that group.

For each batch test, at least 100 mice are poisoned and observed for a period of 3-4 days. During this time, they will experience differing levels of muscular paralysis and impaired vision. Those injected with the highest dose will suffer paralysis of the diaphragm, leaving them unable to breathe and, consequently, they suffocate to death.

Accurate and humane non-animal test methods

Not only is the LD50 test appallingly cruel because of the numbers of animals used and the extreme suffering they undergo, it has long been acknowledged to be so crude as to be meaningless in terms of risk assessment for humans. The government announced in 1999 (after a legal challenge by the British Union for the Abolition of Vivisection) that LD50 tests would no longer be licensed except on 'exceptional scientific grounds'. This is because validated non-animal (in vitro) tests exist.

However, batch-testing of biological medicines - such as botulinum toxin - is one area in which the use of the LD50 is still permitted, despite the existence - in the case of botox - of a number of non-animal potency testing methods. These are not only humane, unlike LD50, they also give accurate and reproducible results.

Cosmetic botox boosts LD50 numbers

Claims that botulinum toxin is tested on animals primarily because of its therapeutic use ignore the fact that the biggest growth area is as an anti-wrinkle treatment.

In the years leading up to the partial ban on LD50 tests in 1999, the number of LD50 tests had been decreasing dramatically, and this trend should have continued. However, according to the Fund for the Replacement of Animals in Medical Experiments (FRAME), LD50 numbers increased significantly in 2001, with a further dramatic rise in 2002.

The rise correlates with a surge in the popularity of cosmetic botox. In the US, between 1998 and 2002, the use of Botox for cosmetic procedures increased by 1500%. According to the International Society of Aesthetic Plastic Surgeons, botox injections were the second most popular cosmetic procedure amongst women in 2001.

Government's double betrayal

So here we have the British government claiming that it has essentially 'banned' both LD50 tests AND cosmetics testing on animals, while continuing to licence (in breach of its own policy) LD50 testing of a cosmetic product! The licensing anomaly relating to botox means that large numbers of animals are paying the price of human vanity with severe suffering and, ultimately, their lives.

Animal Aid is calling upon the Home Office to insist that the industry implement non-animal test methods without delay - and to close the loophole permitting the testing on animals of a cosmetic product. Until that time, Animal Aid calls for a ban on the cosmetic use of botox. We further urge people considering botox injections to reflect on the fact that this dangerous toxin has not been adequately assessed for safety AND that many animals have been pointlessly abused and killed, in the manufacture of the product.

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