Brussels, 28 Apr 2005
Ahead of the EU directive to abolish animal testing in scientific experiments if an alternative test exists, the European Centre for the Validation of Alternative Methods (ECVAM), part of the JRC in Ispra, Italy, is busy validating alternative test methods at EU level.
Speaking to CORDIS News at the JRC exhibition in the European Parliament on April, Raffaella Corvi, responsible for the carcinogenicity activities at ECVAM explained that through its quest for state-of-the-art non-animal test development and validation, ECVAM has made remarkable achievements recently, leading to a dramatic reduction in animal testing.
In 1991, the European Commission created ECVAM to seek alternatives to using animals for experimental and other scientific purposes, stating that 'an experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available.'
As declared in its mission statement, ECVAM 'co-ordinates at the European level the independent evaluation of the relevance and reliability of tests for specific purposes, so that chemicals and products of various kinds, including medicines, vaccines, medical devices, cosmetics, household products and agricultural products, can be manufactured, transported and used more economically and more safely, whilst the current reliance on animal test procedures is progressively reduced.'
Talking to CORDIS News, Dr Corvi explained that one of the great successes of ECVAM was the validation of three alternative tests in the field of chemical-induced skin corrosion and phototoxicity. Until now the test material was usually applied on the shaved skin of albino rabbits. The rabbits, following exposure to the test material of up to 4 hours, were observed for any signs of necrosis of the skin. This could take up to 21 days, creating pain and suffering for the animals. One of the newly validated methods, however, makes use of reconstituted human skin, thereby avoiding the need for animal testing and saving the animals a lot of suffering, said Dr Corvi.
'Now that the methods have been validated, the use of in-vitro alternatives for skin corrosion testing and phototoxicity of chemicals is mandatory in the EU and substances can no longer be tested on animals,' explained Dr Corvi. The method has also been accepted at international level by the OECD, thus giving it even more weight and standing.
ECVAM tends to work in close collaboration with industry, added Dr Corvi. 'It is usually the industry that develops alternative methods for screening. But in order to completely replace animal testing for regulatory purposes, it is necessary to assess the scientific validity of the test ,and this is where ECVAM plays an essential role,' she said. 'There are lots of alternative tests around but not all of them are developed enough or validated.'
Rabbits are also used for tests on eye irritation and ECVAM is conducting the evaluation of six major studies in this field.
'The validation of these tests is carried out on a weight of evidence approach and some regulatory institutions already accept the test. However the JRC wants to go further in order to provide a valid harmonised test at international level,' Dr Corvi told CORDIS News.
Turning to her area of research, carcinogenicity, Dr Corvi explained that at present, the only accepted test is a two-year animal test that requires testing on a high number of animals. It also costs one million euro for the analysis of a single substance.
'We are therefore looking for alternatives and one possibility is the in-vitro cell transformation assay based on cell cultures exposed to chemicals,' said Dr Corvi.
According to this method, if the chemical used in the experiment is non-carcinogenic, the cell growth will be in a mono-layer, while if the cell growth is irregular this means that the chemical is potentially carcinogenic. To validate this test, ECVAM is currently comparing in-vitro with in-vivo data.
The test, which will take another three years to be validated, will result in the decrease of animal testing.
'Although test on animals will still be necessary in this very critical area of carcinogenicity, any reduction in the number of animals used, is a victory for us.' concluded Dr Corvi.
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