One Hundred Thousand Mice Killed for Botox in Ireland in 2020

Irish Anti-Vivisection Society Freedom of Information request uncovers evidence of unnecessary suffering in severe tests.

The Irish Anti-Vivisection Society (IAVS) joins the European Coalition to End Animal Experiments (ECEAE), for a continent-wide Day of Action on 9th July 2022 calling for an end to what is the most severe and gratuitous abuse of animals in laboratories.

Botulinum toxin (colloquially known as “botox”) is a neurotoxin that is used for cosmetic purposes such as removal of facial lines, but also for medical applications. Each batch is tested on mice in the so-called Lethal Dose 50 test. Different dosages of the substance are injected into the abdomen of groups of mice to determine the amount at which half of the animals die. Since the poison paralyzes the respiratory muscles, the mice die of suffocation while fully conscious.

Ireland has long been the country with the most botox animal tests in Europe. The official statistics of 2020 reveal that 100,848 mice were subjected to so-called batch potency testing, which most likely are botox tests. The year before 92,887 mice were killed for this purpose, in 2018 it was 138,846 mice and in 2017 192,015 mice.

In 2011, botox company Allergan, who have facilities in Co. Mayo, received approval for a cell-based test to replace the majority of their animal testing. Due to continuous protests by the IAVS and ECEAE, the companies Merz and Ipsen have since replaced at least most of their animal tests for botox. However, because government and industry prioritise commercial confidentiality over compassion for animals, the technology behind the cell-based test has not been shared with other botox companies, and so the excruciating suffering continues on an industrial scale.

New Disturbing Revelations

The IAVS can now exclusively reveal disturbing evidence that historic indifference has made the suffering of innocent animals even worse in Irish botox tests. Documents released to the IAVS by the Health Products Regulatory Authority indicate that a systemic failure to develop and validate less severe tests, as well as slack monitoring in botox testing labs has led to unnecessary severe suffering and agonising deaths.

In ‘Botox test review 01’ (Section G), dating from 2016, the HPRA assessor’s comment imply previous monitoring of the dying animals has been inadequate:

“Humane endpoints are being introduced for a procedure that to date has required death as an endpoint. This will involve increasing the monitoring of the animals to humanely euthanise the animals prior to death.”

[NB ‘Humane’ endpoints are not really humane, just slightly less cruel than allowing the test to continue until the animal dies.]

Another review in 2016 similarly comments:

“Humane endpoints have been introduced for a procedure that previously required death as an endpoint. This involved increasing the monitoring of the animals to humanely euthanise the animals prior to death.” (Botox test interim review 3)

In the same project, an error lead to an additional five mice having to endure the LD50 test:

“An invalid result was obtained for one study, which was due to an operational error during sample preparation. This resulted in 5 additional assays being conducted.”

Then, ‘Botox review 16’ from 2021 reveals that the experiments in this project caused greater suffering for the animals due to mistakes in the potency of the botox, implying inadequate monitoring once again which would have prevented the pain of those animals exceeding the authorised limits:

“However 68% of the 3,001 mice used to date have been reported as experiencing an actual severity of severe. The reason for this increase above what was predicted [i.e. 40%] is that this testing had been moved from a CRO in [redacted], and during the first two studies performed at [redacted], the potency of the test item was found to be much higher than expected.”

The European Pharmacopoeia which regulates the batch testing of botox products allows a number of animal-free test methods, but it also still allows the LD50 test on mice. The IAVS and ECEAE urge the EU regulatory authority to delete the mouse assay from the Pharmacopoeia to end the appalling animal suffering for this test for good.

The IAVS and ECEAE also supports the European Citizens Initiative ‘Save Cruelty Free Cosmetics’ which aims at a phase-out plan for all animal experiments. Their target of one million signatures have to be collected by 31st August in order to get the European Commission to act.

Further information

European Citizen’s Initiative ‘Save Cruelty Free Cosmetics’: www.endanimaltesting.eu

Botox animal testing: https://www.eceae.org/botox.html