FDA's priority-based assessment of food additives. II. General toxicity parameters.

We examine in greater depth some general toxicity parameters that have been compiled for food additives in the Priority-Based Assessment of Food Additives project. Correlations between chemical structure categories and basic parameters such as lowest effect level, highest no-effect level, and study duration indicate (among other things) trends in these parameters that are consistent in magnitude and direction with the Concern Level break points proposed in the FDA's Redbook. Certain data on the nature and extent of observed toxic effects of additives, when related to corresponding estimated levels of human intake, help to provide a profile of toxicological characteristics of a number of the regulated additives. The resulting breadth of such a profile reinforces the need for systematic priority setting in the allocation of resources to potential food additive safety concerns.