ABSTRACT
Over the years, many tests have been devised to determine the adverse effects of chemicals in living organisms. Procedures are available for use with intact animals, laboratory-cultured single-cell organisms, isolated organs (perfused liver or lungs), or mammalian cell lines. Toxic endpoints used by investigators range from the traditional acute lethality, weight loss, and carcinogenesis to exciting new tests for effects of immunosuppression, behavioral aberrations, and genetic injury. Given this spectrum of procedures, an orderly and systematic approach to toxicity testing is undeniably needed. One of the first proposals in the U.S. for a systematic strategy involved the safety decision tree approach of the Food Safety Council Scientific Committee in 1980. In 1982, the publication titled
Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives used in Foods
(also known as
Redbook I
) was developed by the U.S. Food and Drug Administration, Bureau of Foods (now the Center for Food Safety and Applied Nutrition, CFSAN). The draft for
Redbook II
was available in March 1993, followed by
Redbook 2000: Toxicological Principles for the Safety of Food Ingredients
, which is available electronically at https://vm.cfsan.fda.gov/~redbook/red-toct.html.
