Press release

Published: 16 July 2024

Animal-free test has been available for 30 years

For decades, the rabbit pyrogen test (RPT) was the standard method for detecting fever-inducing substances, so-called pyrogens, in infusion solutions, vaccines and other injectable drugs. In the RPT, the rise in body temperature in rabbits is measured following injection of the test substance into the ear vein. In Germany alone, around 6,000 rabbits were used every year. Now the test will be deleted from the European regulations. Doctors Against Animal Experiments regards this step as a ‘great success for animal welfare’, but the organisation criticises the fact that animals still have to suffer for pyrogen testing.

The rabbit pyrogen test (RPT) is a regulation of the European Pharmacopoeia (Ph. Eur.). In June 2024, the Ph. Eur. commission of the EDQM, the authority responsible for the pharmacopoeia, adopted 57 revised monographs from which the RPT was deleted, together with a new general chapter on pyrogenicity testing. This finally means the end of the rabbit test - at least in Europe.

However, the changes will only come into force from 1 July 2025 with the publication of the new version of the European Pharmacopoeia. After this date, it will be the responsibility of drug developers to use a suitable in vitro test (e.g. the MAT test developed more than 30 years ago) to control the pyrogenicity of their product.

“This is a huge success for animal welfare and the use of modern in-vitro approaches,” says Dr Corina Gericke, Vice Chair of the nationwide association Doctors Against Animal Experiments. The association had campaigned against this test and ended the campaign when the EDQM announced the phasing out of the RPT within five years in 2021. The end of the rabbit test will now be implemented even a year earlier than planned.

“The slow but definitive end of the rabbit pyrogen test is an important step,” says veterinarian Gericke, but at the same time criticises the fact that animals continue to suffer for pyrogen testing. Every year, around 550,000 horseshoe crabs are drawn out of the sea to extract a third of their blue blood. This is used for the Limulus amoebocyte test (LAL test), which is a standard test for detecting pyrogens. “The LAL test is often even promoted as an ‘alternative’ to the rabbit test. However, animal-free methods have also been available for this test for years. We are calling for the LAL test to also be deleted from the European Pharmacopoeia,” explains Gericke. Doctors Against Animal Experiments is collecting signatures on the association's website in favour of the deletion of the LAL test.