The revised FDA Redbook guide lines presented in this article reflect current thinking concerning male reproductive toxicology. A number of different end-points to assess m ale repro ductive function have been included in the present draft of the FDA Redbook II guidelines to better assess potential effects of direct food additives and color additives on male reproductive function. The guidelines reflect a harmony with the development of the guidelines of regulatory agencies in this country and around the world.
References
1.
Hess, R. A., and Moore, B. J.1993. Histological methods for evaluation of the testis. In Male reproductive toxicology, eds. R. E. Chapin and J. Heindel. pp. 52–85. San Diego, CA: Academic Press.
2.
Russell, L. D., Ettlin, R. A., Sinha Hikim, A. P., and Clegg, E. D.1990. Histological and histopathological evaluation of the testis. Clearwater, FL: Cache River Press.
3.
Organization for Economic Cooperation and Development. 1996. OECD guideline for testing of chemicals. Proposal for new guideline 416. Two-generation reproduction toxicity study, pp. 5–11. Draft document, April. Paris: Organization for Economic Cooperation and Development.
4.
U.S. Environmental Protection Agency. 1996. Health effects test guidelines, OPPTS 870.3800, reproduction and fertility effects, pp. 1–11. Washington, DC: EPA 712-C-96-208.
5.
U.S. Food and Drug Administration. 1994. International Conference on Har-monisation; Guideline on detection of toxicity to reproduction for medicinal products; Availability. Fed. Reg. Part IX, 59(183):48746–48752.
6.
U.S. Food and Drug Administration, Bureau of Foods. 1982. Toxicological principles for the safety assessment of direct food additives and color additives used in food. Washington, DC: U.S. Food and Drug Administration, Bureau of Foods.
7.
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. 1993. Toxicological principles for the safety assessment of direct food additives and color additives used in food, “Redbook II” (Draft). Washington, DC: U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition.
