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  • Safety assessment for Tris(...
    Markley, Laura C.; González Bonet, Andrés M.; Ogungbesan, Adejoke; Bandele, Omari J.; Bailey, Allan B.; Patton, Geoffrey W.

    Food and chemical toxicology, August 2023, 2023-Aug, 2023-08-00, 20230801, Letnik: 178
    Journal Article

    During and after fabrication of polymeric food contact articles (FCA), polymers undergo oxidation by thermal decomposition processes initiated by oxygen, heat, light, shear, and catalyst residues. To reduce degradation of the polymer, a commonly used secondary antioxidant (AO), Irgafos 168 (I-168), may be included. Use of I-168 in polymeric FCAs presents a potential concern for neurotoxicity due to its phosphate-containing degradation species, I-168ate. As a result, we evaluated dietary exposure and oral toxicity data for I-168 and its degradants when used as an AO in FCAs. Our exposure assessment included extensive review of the U.S. food-contact regulatory history of I-168 resulting in a combined cumulative estimated daily intake (CEDI) of 0.09 mg/kg bw/day for I-168 and I-168ate when used as an AO in FCAs. Our comprehensive literature review of toxicological data and supporting structure activity relationship (SAR) analysis of I-168 reactivity against acetylcholinesterase diminished concern for potential neurotoxic effects of I-168 and its degradants. An acceptable daily intake (ADI) value of 1 mg/kg bw/day for I-168 was derived from a two-year rodent combined chronic toxicity/carcinogenicity study, which is higher than the CEDI and supports the safety of current authorized food contact use levels of I-168. •US FDA conducted a post-authorization review for the food contact uses of I-168.•CEDI for I-168 (phosphite and phosphate) is 0.09 mg/kg bw/day.•ADI for I-168 was derived to be 1 mg/kg bw/day, which is above the CEDI.•There is no safety concern for current authorized food contact use levels of I-168.