InVitro Synthetic Skin Approved to Replace Rabbits
Research Triangle Park, North Carolina, March 21 (Bloomberg)
-- InVitro International's synthetic skin test Corrositex was approved by multiple U.S. regulatory agencies to replace rabbits in testing the safety of thousands of new chemicals.
The agreement by the Environmental Protection Agency, the Occupational Safety and Health Administration, the Consumer Product Safety Commission and others marks the first time U.S. regulators jointly approved a full-scale replacement of an animal test.
The tests, previously performed by putting chemical mixtures on the skin of live laboratory rabbits, are done to determine if the new products will cause chemical burns. Reactions such as corrosion can cause serious damage to consumers and those who work with chemicals, including
permanent scars.
"The old test requirements called for three animals for each chemical that is evaluated for skin corrosivity and dermal irritation,"' said William Stokes, associate director for animal and alternative resources at the National Institute of Environmental Health Sciences. Since there are more than two thousand chemicals introduced each year,the substitution of Corrositex could save many laboratory animals in a year.'
The agreement was announced by the National Toxicology Program, part of the National Institute of Environmental Health Sciences, based in Research Triangle Park, North Carolina. While individual agencies approved the test in previous years, the effect was limited because some agencies, like the Consumer Product Safety Commission, or CPSC, didn't accept it.
``Companies will see the credibility of the non-animal- testing approach in a much better light with the CPSC accepting a non-animal system for the first time in its history,' and other agencies embracing it more boldly and openly, said W. Richard Ulmer, president of InVitro, based in Irvine, California. ``It's really been the credibility that stops us from being used.'
Collagen Imitates Skin
The new test uses a collagen substance that works like synthetic skin. The experimental chemical's corrosive level is determined by how quickly it penetrates the collagen barrier. ``Because it's inexpensive and quick, and it's done in your own laboratory, you can shorten the product development cycle,' Ulmer said.
While animal tests can cost up to $1,000 per sample tested, Corrositex can cost as low as $110 or $120, he said. A scientific panel last year recommended that some new chemicals be tested exclusively with the synthetic test, while other chemicals should be assessed with animals after the new test determines it is probably safe. Some chemicals, however, will still need the full animal-testing approach, they said.
The regulatory agencies also are planning to notify industry groups and other research institutions that the synthetic test is acceptable in lieu of rabbit testing. U.S. regulatory agencies previously approved a change in a common
allergic dermatitis test. The test, performed earlier on guinea pigs, now is done on mice and uses fewer animals.
Mar/21/2000 17:00
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