EFSA cannot conclude on the safety of ethoxyquin as a feed additive for any target animals, its safety for consumers or the environment. This is due to an overall lack of data to assess the safety of the substance, including its metabolites, and the presence of an impurity (p-phenetidine) which is a possible mutagen.
The additive ethoxyquin contains ≥ 91 % ethoxyquin, ≤ 8 % ethoxyquin polymers and ≤ 3 % p-phenetidine. It is intended for use in all animal species as an antioxidant at a maximum content of 50 mg/kg complete feed. Ethoxyquin is rapidly absorbed after oral administration. Ethoxyquin oxidation in feed materials and in animals leads to four main compounds: 2,4-dimethyl-6-ethoxyquinoline, ethoxyquin N-oxide, ethoxyquin quinone imine, and ethoxyquin dimer (detected only in fishmeal and in salmon). Ethoxyquin itself is not genotoxic or carcinogenic, and does not cause developmental toxicity. The lowest NOAEL (based on studies in rats and dogs) is 2 mg/kg body weight per day. The genotoxic profile of the dimer reflects that of ethoxyquin. Ethoxyquin quinone imine shows structural alerts for mutagenicity, carcinogenicity and DNA binding; no conclusion on the absence of genotoxicity of ethoxyquin quinone imine is possible. p-Phenetidine is a recognised possible mutagen. Concentrations of 50 mg ethoxyquin/kg and 11 mg ethoxyquin/kg complete feed might be considered as potentially safe for chickens and breeders and for dogs, respectively. No conclusion on potential safe levels for other poultry, pigs, ruminants, fish and cats is possible. Overall, when considering the presence of p-phenetidine in the additive, no conclusion on any safe level of the additive for target animals can be drawn. An assessment of safety for the consumer is prevented by the lack of exposure data, the absence of a safe level of exposure and the presence of p-phenetidine in ethoxyquin. The respirable mist of ethoxyquin is of low toxicity. Ethoxyquin is not a dermal irritant, but is considered a potential irritant to eyes and other mucous membranes and a skin sensitiser. No conclusion on the safety for the environment can be made. Ethoxyquin is a potent antioxidant; however, no data confirm its efficacy at the proposed use level.
Wednesday November 18, 2015/EFSA.