Testing Guidelines for Evaluation of Reproductive and Developmental Toxicity of Food Additives in Females

Abstract

The original Redbook issued by the Food and Drug Administration in 1982 pro-vided guidelines for testing the effects of direct food additives and color additives on mothers and developing embryos. The tests included brief teratol-ogy/developmental toxicity studies and longer studies spanning several generations called multigeneration reproduction studies. In 1993, the draft version of Redbook II was made available for public comment. In it, the revised chapter on reproduction and developmental toxicity is the result of extensive literature review and public comment. It includes discussions of the major mani-festations of an effect on the developing organism — death, structural anomaly, altered or retarded growth, and functional deficiency — and evaluation of these manifestations with respect to dosage and other factors. Additional test end-points and developmental landmarks are included and evaluated. The use of the degree of maternal toxicity in assessing fetotoxicity or embryotoxicity is discussed. FDA's revised guidelines for developmental toxicity and multigeneration reproduction studies are described and compared with current EPA draft guidelines and the guidelines issued by the OECD.