Reproductive and developmental toxicity risk assessment for 4-methylimidazole.

Abstract

4-Methylimidazole (4-MEI) is present in caramel color for food and beverages and as a by-product of the thermal treatment of food. A risk assessment for 4-methylimidazole reproductive and developmental effects was conducted using data from a National Toxicology Program Reproductive Assessment by Continuous Breeding and using 90^th percentile dietary exposure data from the U.S. Food and Drug Administration. The National Toxicology Program reported reproductive and developmental toxicity in Sprague Dawley rats from high dietary exposure to 4-MEI. Using the benchmark dose method of modeling dose-response curves, the lowest margin of exposure (MOE) was 1489. Using the traditional no observed adverse effect level (NOAEL)/lowest observed adverse effect level (LOAEL), the margin of exposure at the 90^th percentile human consumption was 735. MOEs of 100 or greater are considered to be of low concern. In conclusion, human exposure to 4-MEI in the diet in the United States is not expected to confer risk to reproduction or development.