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Botulinum toxin (commonly known as botox) is a nerve toxin and one of the most toxic substances known.. Botox® is also the brand name for one of several products containing botulinum toxin. Other brand names include Dysport ®, Xeomin ® and Vistabel ®. It is most commonly used for the temporary treatment of facial wrinkles and lines.
The Cosmetics Directive bans the testing of cosmetic products and ingredients on animals in the EU. However botox is actually licensed in the EU for the treatment of relatively rare medical conditions, even though it is most commonly used for the temporary cosmetic treatment of facial wrinkles. Unfortunately EU legislation allows botox to be used 'off label' – meaning a product that is classified as a 'medicine' and tested on animals, can legally end up being used for cosmetic purposes.
It is estimated that 300,000 mice are used worldwide to test botox each year. The BUAV discovered that one UK laboratory alone is using up to 74,000 mice a year for botox testing.
Because the toxin is potentially highly dangerous, each batch is tested before it hits the high street. Unfortunately the toxicity test is carried out on mice and is based on the standard LD50 test and classed even by the UK Government, which tends to play down suffering, as being of “substantial severity”.
The LD50 test aims to determine the dose that kills exactly half of the animals used - it is called the LD50 because the lethal dose will kill 50% of the animals. Manufacturers use the LD50 figure to grade the 'strength' of their products. It is an archaic test and one of the cruellest and most controversial animal experiments.
The mice are injected into the abdomen with the botulinum toxin and then periodically observed to see how many die. The mice become increasingly paralysed, eventually gasping for breath and, if left, will suffocate to death. The degree of suffering is appalling.
Most mice in the higher dose categories die during the test. After three or four days the number of mice still alive is counted and an LD50 value calculated.
The BUAV investigation at Wickham Laboratories found that those mice who had not died were killed at the end of the test either by gassing or having their necks broken. Up to 60 mice at a time were loaded into the gas chamber and killed by carbon dioxide poisoning, a death that is far from instantaneous.
No pain relief is provided for the mice during the test.
At Wickham Laboratories in the UK, a BUAV investigator found that as a token consideration to animal welfare, workers were supposed to observe the mice and identify those who were judged unlikely to survive until the next check. These mice were taken out into the corridor and crudely killed on the floor by breaking their necks with a ball point pen.
New members of staff, who had never killed mice before, were expected to practise breaking necks with a ballpoint pen on live mice. However, during this training, staff sometimes broke the backs of mice rather than their necks.
Even experienced staff had problems and caused back injuries. This resulted in what was undoubtedly excruciating agony for the mice.
In fact, a large majority of mice in the relevant categories were found dead rather than being killed to end their suffering.
A number of alternatives to the LD50 test for botox have been developed. For example the SNAP-25 assay, which is a method that measures the activity of the toxin in a test tube and which has been used by an official UK Government laboratory since 1999. The American botox company Allergan, has developed a cell-based test which does not use any animals. This test was recently approved by authorities in the U.S., Canada, and many countries across Europe. It is valid only for the botox products of Allergan: Botox®, Botox®Cosmetics and Vistabel®.
The other manufacturers of botox botulinum toxin products claim to be developing their own alternative which can then only be used by them. Allergan has managed to develop a cell-based test and has recently received approval by authorities of several countries which is applicable only for their products. The other two major companies, Ipsen and Merz-Pharma, are still using the cruel and outdated LD50 test. They claim to be working on other replacement or reduction methods but the ECEAE believes they are working too slowly. We are urging them to either get approval for their replacement method or to purchase a license from Allergan which will enable them to use their method.
Allergan has managed to develop a cell-based test which does not use animals to test their products, Botox®, Botox®Cosmetics and Vistabel® and is waiting for this test to receive regulatory approval from regulators around the world. Allergan has stated that they intend to stop animal testing completely as soon as all regulators around the world approve their alternative. The botulinum toxin products Dysport® by Ipsen, Azzalure® by Ipsen/Galderma and Xeomin® and Bocouture® by Merz-Pharma are still tested on animals at all stages of their production.