Published: 14 February 2023

Under the EU chemicals regulation - REACH - companies registering their substances must propose rather than conduct some of the new tests on animals that may be required. Only those animal tests that use the most animals, are lengthier and more expensive to conduct are required to be proposed first. They include the 90-day Repeated Dose Toxicity, Prenatal Developmental Toxicity, Two-Generation Reproductive Toxicity, Long-term Fish or Bird Toxicity and Mutagenicity tests. These tests typically involve mice, rats, rabbits, birds and fish.

One of the important provisions in the regulation that animal protection organisations, including the ECEAE, fought for was the opportunity to comment on these testing proposals. For each testing proposal REACH says that third parties have 45 days in which to submit ‘scientifically valid information’ to the European Chemicals Agency (ECHA) who are obliged to take the information into account when deciding whether the test needs to be done.

Between 2009 and 2015, the ECEAE commented on these proposals with the help of employed toxicologists. Our comments included pointing out that the test was not necessary according to the REACH regulation (usually because it was a test required for substances produced in higher volumes than the substance was) and finding existing test data on the substance or a similar substance which meant the test did not need to be done.

As a result, out of 540 comments a final total of 98 tests were prevented or modified. This is a success rate of 18% and the total animals saved is 103,427, mostly rats.

In 2018 ECEAE member Doctors Against Animal Experiments contributed financially to a short term project led by Cruelty Free International to comment on a batch of testing proposals including those for the Extended One Generation Reproductive Toxicity Study (EOGRTS). This was a new animal study that is intended to use fewer animals than the Two Generation Reproductive Study, but only if it is not ‘extended’. In this test male and female rats are force-fed the substance until they are mated and produce young. The pups are then force-fed the substance until they are also mated and produce young. Adults and pups are all observed for signs of ill-health before being killed.

This work resulted in comments that helped prevent or modify 17 proposed animal tests (31% of the comments), saving an estimated 11,710 animals, mostly rats.

Examples of tests prevented from the 2018 project

The company wanted to test Calcium cyanamide (a fertiliser) in an extended one generation reproductive toxicity test using rats. Although they had previously relied on data from another similar substance to avoid other animal tests, in this case they did not want to as they felt that this would overestimate the toxicity of the substance. ECHA agreed with us that they should use the data from the similar substance and rejected the proposal, saving 960 animals.

ECHA agreed with us that a fully extended one generation reproductive toxicity test using rats for a fuel additive (N-methylaniline) was not needed because no reproductive effects had been seen in other studies, saving 1,720 rats.

ECHA agreed with us that registrants of a lubricant used in brake fluid (Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., calcium salts (2:1)) should use the results from the same fully extended one generation reproductive toxicity test using rats done on a very similar substance and not repeat the test, saving 1,720 rats.