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New test eliminates need for skin irritancy tests on rabbits


The Scientific Advisory Committee of European Centre for the Validation of Alternative Methods (ECVAM) has today announced the validation of five new "in-vitro" tests, which take an important step towards ending the practice of using rabbits in skin and eye irritancy testing. These tests will apply to many everyday products such as washing-up liquid, face cream or make-up, and also literally thousands of industrial chemicals that will have to be assessed under the new REACH chemicals legislation. One of the validated tests mimics human skin and predicts the skin irritancy potential of chemicals with great accuracy and precision and will therefore fully replace tests on rabbits. Two other tests can identify severe eye irritants, thereby avoiding the need to use the live rabbit eye test. Furthermore, a new validated test strategy for skin allergy cuts animal use by half saving up to 240,000 mice in the implementation of the REACH legislation. These tests, validated by a committee composed of nominees from the EU Member States, industry, academia and animal welfare, must now be accepted by regulatory authorities and in the Member States. The role of ECVAM, which is based at the European Commission's Joint Research Centre is to replace, refine and reduce methods of animal testing for cosmetics, drugs and chemicals.

The two tests for skin irritation validated today have been developed by industry and private companies and previously validated by ECVAM. The tests use in-vitro cell culture to evaluate the potential skin-irritancy of chemicals, by providing a realistic representation of the properties of human skin to identify irritant and non-irritant chemicals. These tests are the outcome of three years work involving 9 private and public organisations in the EU and US. The validation by ECVAM is an important step as it ensures that these tests can replace animal tests and at the same time provide the level of protection that consumers need against potentially harmful ingredients.

Potential skin irritants - such as cosmetics, cosmetic ingredients and all new chemicals - must be tested to ensure that they are labelled appropriately for the risk they pose to humans. All such testing is currently carried out on animals - approximately 20,000 per year, predominantly rabbits. However, not only are such rabbit tests unsatisfactory from an animal welfare point of view, their scientific quality is also questionable. They are based on subjective judgement rather than a rigorous measurement of effect. In addition, rabbit skin does not always react in the same way as human skin. The REACH Regulation currently foresees the rabbit skin irritation test for 10,000 chemicals which have already been on the market for more than 25 years. It will now be possible to replace these with the new tests using human skin grown in the laboratory.

Two other tests validated today will identify eye irritants using tissues from slaughter-houses, which would otherwise be discarded. Here again, the test will replace the use of animals to identify severe irritants, though some animal testing will still be required for mild irritants. However, eight other models are currently under evaluation by ECVAM which if successful will completely replace testing on live rabbit's eyes. Work in this field is a joint effort with U.S. counterparts, which will ease international acceptance of the new tests.

Skin allergy is an occupational health problem which costs the European economy about 3 million work days every year - costing about €600 million. All 30.000 chemicals falling under the REACH legislation are therefore to be tested for skin allergies with a test using mice. The fifth test validated today can cut this by half, saving about 240,000 mice.

These five tests are an important part of the European Commission's policy to reduce, replace and refine tests on animals in the EU. This policy is particularly relevant in the light of the latest amendment to the Cosmetics Directive, which will ban the testing of cosmetic ingredients on animals from 2009, as well as the forthcoming REACH Chemicals legislation, which comes into force on 1 June 2007.

Source: EU Commission