|FOR IMMEDIATE RELEASE
Wednesday, October 3, 2001
Drop of 30 Percent in Use of Animals in Some Chemical Tests Could be Quickly Achieved Through Use of Cells, U.S. Says
- On Aug. 21, in a meeting set up by the National Toxicology Program's Interagency Center for the Evaluation of Alternative Toxicological Methods, U.S. scientists agreed on final adjustments to a U.S. test called the Up-and-Down Procedure so that it can replace the LD50 test. Although it takes longer, the Up-and-Down test gives good results with as few as six to nine rats.
Two other alternative tests, each using only eight to 14 rodents, have been developed in Europe. The Fixed Dose Procedure, first suggested by the British Toxicological Society in 1984, is based on dosing at a series of fixed dose levels, with 5 animals dosed at each level. The approach avoids the use of death as an endpoint, instead relying on the observation of clear signs of toxicity. The Acute Toxic Class Method, developed in Germany, is a stepwise procedure with the use of 3 animals per step. It is based on biometric evaluations of the results of fixed doses ( the same series of dose levels in the FDP), which are adequately separated to enable a substance to be ranked for hazard classification purposes.
- The Organization for Economic Cooperation and Development, an international trade group that includes several European countries, Japan and the United States is removing the old LD50 test from its guidelines. Within a year of final OECD approval, the older animal-intensive LD50 method can be replaced by the regulatory agencies of the member governments with less animal-intensive tests such as the three above. This official, international switch to the new tests is expected in the latter months of 2002.
- U.S. regulatory agencies are also moving to accept the new, substitute test results.
Much of the work to reduce animal test requirements has been fostered by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) which was organized by NIEHS in 1997 to evaluate new test methods. ICCVAM is composed of representatives from 15 federal agencies the Agency for Toxic Substances and Disease Registry, Environmental Protection Agency, Consumer Product Safety Commission, Food and Drug Administration, Department of Agriculture, National Institutes of Health, Department of Defense, National Cancer Institute, Department of Energy, NIEHS, Department of the Interior, National Institute of Occupational Safety and Health, Department of Transportation, National Library of Medicine and the Occupational Safety and Health Administration. ICCVAM's work gets staff and other support from the National Toxicology Program's Interagency Center for the Evaluation of Alternative Toxicological Methods, or NICEATM, which organized the workshops from which the two reports released today were developed.
Other alternatives which have gone into general use under ICCVAM's auspices have substituted for more animal-intensive tests for allergic contact dermatitis and for the corrosiveness of chemicals on the skin.