The EFSA ANS Panel was asked to deliver a scientific opinion re-evaluating dodecyl gallate (E 312) as a food additive. The Panel considered that whilst from theoretical considerations dodecyl gallate could be metabolised to dodecyl alcohol and gallic acid, there were insufficient data to demonstrate the rate and extent of dodecyl gallate metabolism in vivo. Having reviewed the data on the toxicokinetics (rate and extent of metabolism) of propyl, octyl and dodecyl gallate in a previous EFSA evaluation of propyl gallate, the Panel concluded that the available metabolism data on gallates were insufficient to provide a basis for the read-across of systemic toxicity data on propyl, octyl and dodecyl gallate to be valid. The Panel noted the absence of concern for genotoxicity and the lack of increase of tumours in the long-term study. However, owing to the lack of detailed reports on carcinogenicity and chronic toxicity studies with dodecyl gallate and the absence of a basis for read-across for systemic toxicity from propyl gallate data, the Panel could not reach a definitive conclusion on the presence or absence of a carcinogenic potential of dodecyl gallate. The Panel noted that there was no indication for overt toxicity in the available studies; however, owing to the limitations of these studies, the Panel was unable to identify any NOAEL. Overall, the available database was too limited to either establish an ADI or serve as a basis for a margin of safety approach to be applied with confidence. The Panel concluded that although there was unlikely to be a safety concern from the single use for which usage and analytical data were provided, an adequate assessment of the safety of dodecyl gallate as a food additive would require a sufficient toxicological database in line with its current guidance for submission for food additives evaluations. The Panel noted that the available studies on acute toxicity of dodecyl gallate in rats and pigs indicated low acute oral toxicity. There were short-term and subchronic toxicity studies on dodecyl gallate in rats, dogs and pigs, which reported no overt toxic effects of dodecyl gallate. However, the Panel noted that the available studies were poorly reported and was unable to identify a no observed adverse effect level (NOAEL) from these studies.No data on genotoxicity of dodecyl gallate were available. The Panel considered that for the evaluation of the genotoxic hazard of intact dodecyl gallate, read-across from data on propyl gallate and from in silico expert system was scientifically justified. Therefore, based on the available in vitro and in vivo results on propyl gallate, which provide a limited evidence of genotoxicity in some in vitro systems and no evidence in tests in vivo with adequate systemic exposure, the Panel concluded that dodecyl gallate was unlikely to raise concern for genotoxicity.The Panel noted the absence of concern for genotoxicity and the lack of increase of tumours in the long-term study. However, owing to the lack of detailed reports on carcin...
