Federal Agencies Approve InVitro Skin Test

Irvine-based InVitro International’s synthetic skin test Corrositex has been approved by several 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 whether the new products will cause chemical burns. Reactions such as corrosion can cause serious damage, including permanent scars, to consumers and those who work with chemicals.

The old test requirements called for tests for each chemical to be performed on three animals to evaluate skin corrosiveness and irritation, said William Stokes, associate director for animal and alternative resources at the National Institute of Environmental Health Sciences. “Since there are more than 2,000 chemicals introduced each year, the substitution of Corrositex could save many laboratory animals in a year,” he said.

The agreement was announced Tuesday by the National Toxicology Program, part of the National Institute of Environmental Health Sciences, based in Research Triangle Park, N.C.

While individual agencies approved the test in previous years, the effect was limited because some agencies, such as the Consumer Product Safety Commission, 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 and chief executive of InVitro. “It’s really been the credibility that stops us from being used.”

The company’s stock closed unchanged Tuesday at 15 cents a share in over-the-counter trading.

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.

While animal tests can cost as much as $1,000 per sample tested, Corrositex can cost as little as $110 or $120, Ulmer said.

A scientific panel last year recommended that some new chemicals be tested exclusively using the synthetic test, while other chemicals should be assessed using animals after the new test determines they probably are 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.