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Toxicology Testing Called Into Question

Cell Culture Tests More Accurate Than Lethal Animal Tests

Good news for consumers, toxicologists and animals; 10-year multicenter study proves cell culture tests more accurate than Lethal Dose 50% (LD50) tests in predicting toxicity.

In the LD50 test animals are poisoned with substances ranging from a new paint to a new headache medicine, until half of them are dead. This is the international 'standard' in toxicology (study of poisoning).

Dr. Bjoern Ekwall, chairman of the Cytotoxicology Laboratory (CTLU), based in Sweden, recently reported conclusive proof that an inexpensive battery of cell culture tests is considerably more accurate in measuring and understanding toxicity than are the animal tests currently used. Dr. Ekwall's announcement came at the 17th Scandinavian Society of Cell Toxicity (SSCT) In Vitro Toxicology Workshop in Rostanga, Sweden. Dr. Ekwall is an internationally recognized authority on developing a more scientifically sound, in vitro (non-animal) approach to toxicity testing.

The new toxicity test uses cell cultures instead of animals. It was evaluated in a 10-year, multicenter study involving 29 laboratories in 15 countries, including the USA, Japan, Canada, Mexico, England, France, Spain, Italy, Germany, the Nordic countries and Russia. According to Dr. Ekwall, U.S. agencies (ICCVAM) are now validating the in vitro test as a possible replacement for tests such as the LD50 in which the animals studied often experience prolonged suffering and painful deaths.

Major early funders of Dr. Ekwall's research include the Boston-based New England Anti-Vivisection Society (NEAVS) and the American Fund for Alternatives to Animal Research (AFAAR), based in New York City. "We consider the nearly $200,000 in funding we have provided for Dr. Ekwall's studies since 1985 to be money well spent," said Dr. Theodora Capaldo, President and Executive Director of NEAVS. "At NEAVS, our mission is to end animal experimentation. Dr. Ekwall has proven that animal experimentation is not only painful and lethal to animals, it is flawed and misleading science," she said. The average consumer comes in contact with thousands of chemicals, used in all sectors of modern society, Dr. Ekwall said. He added that these chemicals are routinely safety-tested on living animals without anesthesia: "This causes hideous suffering for the animals."

"Prediction of human lethal and toxic doses is poor due to species differences between animals and humans, and the toxic mechanisms of the chemicals cannot be directly predicted using current animal tests," Dr. Ekwall noted. "In fact, the predictive accuracy of the LD50 tests on rats and mice has been estimated by us to be only 60 and 65% respectively," he said.

The non-animal tests developed by Dr. Ekwall's group, using human cell line cultures, is 75% accurate in predicting human lethal toxicity - considerably greater than the lethal animal tests in which untold suffering is inflicted on a group of animals.

According to Dr. Ekwall,

"Using animals to assess the risk of acute human chemical poisoning has shortcomings. Results are given only as a toxic dose, which is simply a gross measurement of several different events. The test can point out toxic symptoms, but cannot directly point out toxic mechanisms.

"So, not only do these non-animal tests have a higher precision than traditional tests, the main advantage of this approach is improved understanding of toxic events," Dr. Ekwall commented.

The results of the multicenter study also were reported in the latest (August October, 1999) issue of Toxicology In Vitro.

Max Newton, Uncaged Campaigns
[Source: ALL FOR ANIMALS Newsletter-10/99, www.allforanimals.com. Originally reported: BOSTON--(BW HealthWire)]


LD50 On the Way Out...?

UK Licensing Policy Successfully Challenged

The completion of Dr Ekwall’s ‘alternative’ testing method coincided with a successful challenge to the UK Government on the issue of licenses to perform the LD50 toxicity test.

The position of the UK Government has always been that whilst they accept that there are 'less severe' alternatives to the LD50, they would have to continue to issue licenses for the painful and fatal LD50 test where other countries required it for products to be sold within their borders.

However, campaign group the BUAV persuaded the government that this was legally wrong. If the government accepts that there are alternat ive testing procedures that are equal or greater in their predictive accuracy, Section 5(5) of the Animal (Scientific Procedures) Act 1986, as well as European Union Directive 86/609, make it illegal to continue to issue licenses for the LD50.

An announcement has now been made in the UK Parliament, and a press release issued by the Home Office. There has been one license which included the LD50 issued after September 1998 (the point at which the European Directive was brought into UK law) and 'this will now be changed to exclude the [LD50] test, and to further review all licenses for skin corrosivity and photo-irritation tests.

However, these developments will not cover the toxicity testing of vaccines by the Protective Dose 50% (PD50), or the Lethal Concentration 50% test which has the same purpose as the LD50 test, but in which the chemicals are administered through inhalation or water.  

Max Newton, Uncaged Campaigns
[Source: Home Office Press Release 21/10; World Animal Net release 1/11]

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Uncaged 1993-2012: This is the archived website of Uncaged. All information correct at the time of archiving - November 2012.