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BUAV comments on ‘local tolerance’ guideline

Animals are subjected to a number of different tests when drug companies try to show the regulators that their new drug is safe. One of the lesser known types of test is called ‘local tolerance’. This is designed to test whether a drug compound will cause irritation and allergy at the site of contact; on the skin if it is applied dermally or around the injection site if it is given by injection.

Often these effects can be assessed in other animal tests that are done at the same time, sparing the use of further animals, but, sadly, sometimes regulators like to see the test done separately. Some of these tests are deeply unpleasant such as the ‘vaginal or rectal irritation test’ in which rabbits are subjected to repeated vaginal or rectal assaults to test if medical products such as spermicides or painkillers will cause irritation there. This European Medicines Agency is reviewing its guideline on this kind of testing and we submitted comment this week to try to improve it.

We were disappointed to find that, so far, the medicines sector does not seem to have taken up alternatives for skin and eye irritation and skin sensitization that are now being used in other sectors like chemicals and cosmetics. We have, however, given the European Medicines Agency examples of where these tests have been used to test the safety of drug, or drug-relevant products and we hope they will include them in their guideline. We particularly hope they will include reference to the exciting 3D human tissue models that can replace the use of rabbits in cruel tests like the skin and vaginal irritation methods.

This is part of our regulatory work that seeks to promote the use of validated alternatives to animal testing to companies and regulators.