Toxicological evaluation and risk assessment of Cyclo-di-Badge, a non-intentionally added substance (NIAS), found in epoxy based coatings of food cans

Cyclo-di-Badge (CdB) is a by-product of epoxy resin coatings applied to the inside of food cans. By-products are non-intentionally added substances (NIAS) with potential to migrate into food. Due to the lack of data on CdB, studies were conducted to identify potential health hazards. Toxicokinetics study results show negligible amounts of [ 14 C]-CdB excreted in expired air and urine. [ 14 C]-CdB is almost exclusively excreted in the feces with recoveries of ∼100%. The liver plays a role in the excretion of [ 14 C]-CdB with recoveries of ≤7% in the bile with negligible amounts in blood indicating efficient first pass elimination. Genotoxicity tests (Ames and micronucleus) show negative results and the 90-day dietary study results show no adverse effects at levels up to 15,000 ppm (1139 mg/kg). Total recovery of [ 14 C]-CdB in the feces supports the lack of systemic adverse effects in the 90-day dietary study and points to the lack of bioaccumulation potential. To assess risk, the NOAEL of 1139 mg/kg is used to calculate Margin of Safety (MOS) values of 17 (infants), 42 (children), and 247 (adults) indicating acceptable exposures. The lack of adverse effects and risk assessment suggest current CdB levels in canned food are not a concern for human health.