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NEWS
Synthetic Skin System Can Replace Animals in Some Tests of Chemical Safety
March 22, 2000
Several major federal regulatory agencies have agreed to accept chemical safety data from a synthetic skin test in lieu of an animal test -- the first such substitution for live-animal tests. The Environmental Protection Agency, the Occupational Safety and Health Administration, and the Consumer Product Safety Commission are preparing Federal Register notices to tell industry and other research institutions they can use the non-animal test for regulatory purposes.
In the new test, developed under the trade name Corrositex®, a chemical or chemical mixture is placed on a collagen matrix barrier that serves as a kind of synthetic skin. Corrositex® can replace, in many uses, a method in which the chemical or chemical mixture is applied to the intact skin of a laboratory animal.
"The old test requirements called for three animals for each chemical that is evaluated for skin corrosivity and dermal irritation," said William Stokes, D.V.M., 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."
Skin corrosiveness testing is conducted to ensure that chemicals and products are properly labeled to alert consumers and workers to take precautions to prevent chemical burns to the skin. Corrosion is more serious than skin irritation and involves permanent damage to skin, usually with scarring.
A scientific panel, sponsored by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), reviewed the new test last year and recommended it to the regulatory agencies. This method could fully replace the use of animals for testing corrosiveness in some cases, the panel said. In other cases, a chemical determined to be "probably safe" by Corrositex® would still need an animal test to confirm that it is not corrosive. Some chemicals cannot be evaluated in the assay at all and must be tested using the standard animal test.
This is the second alternative test to be approved by federal regulatory agencies after an ICCVAM panel review. The first review resulted in the acceptance by regulatory agencies of a test called the Murine Local Lymph Node Assay, which uses fewer animals to determine the potential of chemicals to cause allergic dermatitis. This assay is also less painful and uses mice instead of guinea pigs. Corrositex® is sold as a test kit by InVitro International of Irvine, California.