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Cell experiments instead of animal experiments - major progress in global animal welfare

36/2001, 15.11.2001

After the EU, the OECD is now also recommending cell tests to examine chemicals and body care products

Two animal experiment models, which up to now had been stipulated at the international level for the testing of medicinal products, chemicals and also cosmetics, will probably soon be replaced with tests that do not require the use of animals. Expert bodies of the OECD (Organisation for Economic Co-operation and Development) have recommended the replacement of animal experiments with non-animal tests employing cells and tissues to OECD Member States at a meeting in Berlin, at the BgVV from October 30 to November 02. It is to be expected that this will lead to a rapid acceptance of the tests by these countries and subsequently to the global recognition of these test methods. With these tests it is possible to estimate the hazard potential of chemical substances just as accurately as with the customary animal experiments used up to now. After acceptance by the OECD, it will then no longer be permitted to conduct additional animal experiments to test substances for phototoxicity and corrosive effects on the skin.

The alternative methods that will replace animal experiments are a phototoxicity test and two tests for corrosive effects on the skin. They were developed by the BgVV and industry and have been experimentally evaluated in experienced laboratories in Europe for their applicability (validation). It could be demonstrated that the protection of consumers and workers who are exposed to chemicals is not reduced when stressful animal tests are replaced by validated cell and tissue tests. These methods have been accepted in the Member States of the European Union since 2000. Following the unanimous recommendations of the OECD Expert Committees, rapid recognition is expected by the OECD Member States, which include all the major industrial nations. This recognition is especially important because results obtained using OECD test methods are accepted all over the world.

The test on phototoxicity (light toxicity) examines whether chemical substances such as the ingredients of sunscreens and medicinal products, develop harmful properties when exposed to light. A chemical substance is described as phototoxic when following application or ingestion of the substance there is reddening, swelling or other adverse reactions or damage to the skin when exposed to light. Phototoxicity testing is obligatory for medicinal products and for substances used as sun protection filters in cosmetics. In practice, these tests are normally conducted on mice, rats, guinea pigs or rabbits. In the case of the method supplanting animal experiments, cells of mice or human skin are treated with test substances during cultivation in the incubator and exposed to UV light. This test was developed in a co-operation between COLIPA (European Cosmetic, Toiletry and Perfumery Association) and ZEBET (Centre for Documentation and Evaluation of Alternatives to Animal Experiments) at the BgVV and validated in experiments with the financial support of the European Commission. Surprisingly, the cell culture test can predict phototoxic reactions in man far more accurately than the animal experiments. Around the world, the cosmetics industry is already using the new test to examine the safety of UV filter substances in sun protection products.

The two other cell culture tests replace the particularly stressful test for corrosive effects on the skin which, up to now, had been conducted on live rabbits and which was very painful for these animals. One is an in vitro method developed in England with isolated rat skin preparations and the other is a method developed by ZEBET at the BgVV in which artificial human skin models produced by biotechnological processes are used, like for example the commercial model EpidermTM. Testing for corrosion of the skin is required for dangerous substances on the international level in conjunction with health and safety regulations, and transport safety and has direct consequences for labelling, storage and transport of dangerous goods as well as their handling (e.g. gloves, protective glasses, etc.). The approval by the representative of the international transport committee, GESAMP, during the OECD expert meeting is likely to lead to a global ban on the inhumane animal tests currently used to evaluate corrosive substances.

The success at the OECD expert meeting is an encouraging breakthrough for animal welfare and consumer protection in Germany, Europe, Asia and America and also for the BgVV. The Institute was able to impressively demonstrate for the first time using the example of phototoxicity tests and tests for corrosive effects on the skin, that it is possible with the help of experimentally validated cell culture methods to correctly estimate the hazard for man and in this way to replace inhumane animal experiments.

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