Safety assessment for octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate (CAS Reg. No. 2082-79-3) from use in food contact applications.
Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate (CAS Reg. No. 2082-79-3), currently marketed as Irganox 1076 (I-76), is a sterically hindered phenolic antioxidant used in a variety of organic substrates, including those used in the manufacture of food contact articles. In 2012, the US Food and Drug Administration (USFDA), Office of Food Additive Safety (OFAS), initiated a post-market re-evaluation of the food contact applications of I-76. This project aimed to ensure that current dietary exposures from the use of I-76 in food contact articles are accurately captured and the safety assessment considered all relevant and available toxicological information. To accomplish these aims, the USFDA reviewed the available toxicological studies and chemistry information on food contact applications of I-76. Based on this in-depth analysis, a NOAEL of 64 mg/kg-bw/d (female rats) from a chronic rat study and a cumulative estimated dietary intake (CEDI) of 4.5 mg/p/d, was used to calculate a margin of exposure (MOE) of ∼850. We concluded that the previous and current exposure levels provide an adequate margin of safety (MOS) and remain protective of human health for the regulated uses.
US FDA/CFSAN/OFAS, College Park, MD 20740, USA. Electronic address: april.kluever@fda.hhs.gov.
April P
AP
Neal-Kluever
US FDA/CFSAN/OFAS, College Park, MD 20740, USA.
Allan B
AB
Bailey
US FDA/CFSAN/OFAS, College Park, MD 20740, USA.
Karen R
KR
Hatwell
D000818:Animals; D000975:Antioxidants; D002084:Butylated Hydroxytoluene / Q000031:analogs & derivatives* / Q000633:toxicity; D005506:Food Contamination; D018857:Food Packaging; D059022:Food Safety; D006801:Humans; D051381:Rats
D000975:Antioxidants; D002084:Butylated Hydroxytoluene; C024538:Irganox 1076
Exposure assessment; Food contact; Food packaging; Irganox 1076; Safety assessment