An increase in cancer, thousands of deaths due to medication, pollution, extinction of certain species… every day scientists demonstrate that the animal model does not provide a reliable link between the consequences of a chemical product or medication and humans or nature. One Voice is campaigning for new practices in toxicology. A first step has been made with the European REACH law.
The botulinum toxin, which is the source of the most famous anti-wrinkle product, is a dangerous poison. This neurotoxin, which is produced by a bacterium, la Clostridium bolutinum, is the source of botulism, an illness caused by the consumption of out of date food and kills… thousands of mice in its development. Who can guarantee that extended use will not paralyse the muscles of women who can’t do without it? Who has planned for the dramatic consequences on human health or on nature of certain medications (Thalidomide, Hepatitis B vaccine, Isoméride, Cerebrex, Vioxx etc.), insecticides (Gaucho) which have been tested on animals? It seems that the real and potential repercussions of many substances cannot be defined from the animal model. Proof of the scientific relevance of toxicology tests on animals are slim, even non-existent. A European study shows that out of 100 000 chemicals, 98% had unknown effects on human populations. Despite tests on animals, the unwanted effects of medication kill 120 000 people in the European Union and 100 000 people in the United States every year. The animal model is unreliable. Today, it is even obsolete. In fact, the theory of evolution and progress in cell and molecular biology have highlighted the differences between species and have therefore invalidated extrapolations from one species to another (C. Ray Greek, Specious Science: How Genetics and Evolution Revealed Why Medical Research on Animals Harms Humans, Continuum, 2002).
For new practices in toxicity research
Rather than continuing to sacrifice millions of animals, often after making them endure terrible suffering, One Voice is defending other scientific practices in toxicity research, like the use of substitute methods, such as Toxic gene study for which it has funded the demonstration and which has been recognised under the Reach law, or molecular biology which avoid having to work directly on live animals. Sharing existing data, in addition to sparing the lives of animals, would ensure the reliability of a test by comparing information… and often avoid launching a risky substance. It has actually been established, following the comparison of results of animal tests intended to evaluate the carcinogenic nature of chemicals (by absorption in rodents) that nearly half of results recorded differ from one laboratory to another. The development and use of in vitro methods, which are more reliable and less expensive, and limiting the use of chemicals would complete this system and even meet the safety demands established before a product is launched. Only a change in the law and the scientific community will enable us to uproot practices that are now out of date and replace them with more human, high-tech methods.


REACH
Faced with growing concerns from European citizens about the repercussions of chemicals, Europe has voted for a Law on the registration, evaluation and authorisation of chemicals (REACH). This programme came into application in June 2007 and notably provides for a test on toxicity favouring substitute methods. A central agency will now be responsible for recording chemicals produced or imported into Europe at over one tonne per year. The risks will be evaluated by risks. Among these, the substances of “serious concern” whose production cannot be secured, must be identified and eliminated progressively. These are mutagene and toxic substances with limited or non-existent biodegradability. 20 000 of the some 30 000 chemicals that fall within the REACH scope would be tested by methods that do not use animals. This is a first step towards the abolition of animal experiments.
“The probability of a coincidence in experimental results on animals and humans is so slim that it is comparable to a game of chance. Nevertheless, we gamble millions of dollars every year on this improbable game of roulette”.
Professor Herbert Hensel, physiologist, University of Marburg
LD50: DEATH TEST
To develop the most popular anti-wrinkle product in the world, researchers use the “LD50” method, which means “Lethal Dose that kills 50% of animals". These tests are carried out on mice to determine the dose of botulism toxin that has no consequences for the human body. The aim is to determine which exact does will cause death in half the mice used for the test. This is expressed in milligrams of active material per kilogram of animal. This dose is only valid for a precise species and a precise method of entry into the body (ingestion, inhalation, skin application). Each product tested in this way must relate to a sample of at least 20 animals. According to the 2004 statistical report by the Ministry of Higher Education and Research, 3886 rates and mice were subjected to this death test (see page 36 of the report)
Extract from article 13 of the draft REACH law, modified and voted on its 2nd reading by the Commission :
“Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across) […]”.


















