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January 2000 News
New Alternative Test Should Save Thousands of Guinea Pigs
A new test for allergic contact dermatitis has been accepted by four U.S. agencies responsible for protecting public health. All four agencies -- the Consumer Product Safety Commission, the Environmental Protection Agency, the Occupational Safety and Health Administration, and the Food and Drug Administration -- are changing their procedures to accept results from the Local Lymph Node Assay (LLNA).
The LLNA, which tests mice instead of guinea pigs, uses far fewer animals and results in much less pain and distress than the traditional test.
The LLNA, like the traditional test, is needed to determine if a new chemical is likely to cause allergic contact dermatitis in workers and consumers. Contact dermatitis is a major problem for consumers of many products, including cosmetics and household products. It is also the second most common occupational disease, costing industry and workers as much as $1 billion annually in lost workdays and associated loss of productivity.
Allergic contact dermatitis is caused by a variety of substances, from fragrances to some pesticides and industrial chemicals, which trigger an allergic or delayed hypersensitivity reaction.
The decision to accept the LLNA is a major victory for those in the alternatives field who have struggled to speed the validation and acceptance of new methods. On the road to acceptance, the LLNA was guided through a scientific peer-review process by the new Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM's positive report on the new method, issued last year, paved the way to acceptance.
ICCVAM was established to support the validation and acceptance of good test methods that are both more predictable and more humane because they use fewer animals, replace animals with non-animal methods, or reduce pain and distress in animal tests.
According to a joint announcement, the four regulatory agencies said they were in agreement that the LLNA can be used in most instances instead of the traditional guinea pig-based test methods to assess the allergic contact dermatitis potential of chemicals. The new alternative is also faster: it can be completed in a week, as opposed to the three or four weeks required by the traditional method.
The new test was first conceived by Ian Kimber at the Zeneca Central Toxicology Laboratory in England. Kimber collaborated with Frank Gerberick from Procter and Gamble and David Basketter from Unilever to further develop the method and to submit it to ICCVAM.
The LLNA was the first alternative test method to be reviewed using the ICCVAM process. A second alternative test was reviewed in January 1999 by an ICCVAM peer review panel and the panel's recommendations are currently under consideration by regulatory agencies. The method, Corrositex, is proposed as an alternative method to identify chemicals that are corrosive to skin. It uses no animals.