Scientific Report on consumer health-based guidance values for trifluoroacetic acid

Abstract

The European Commission asked EFSA to provide a scientific report according to Article 31 of Regulation (EC) No 178/2002, in conjunction with Regulation (EC) No 1107/2009, to revise consumer health-based guidance values, i.e. acceptable daily intake (ADI) and acute reference dose (ARfD), for trifluoroacetic acid (TFA). EFSA launched a targeted call for data from 6 August to 7 October 2024 and established an EFSA Working Group. Based on the weight of evidence, the WG concluded that TFA and its salt, TFA Na, are unlikely to be genotoxic. The WG established an ADI of 0.014 mg/kg body weight (bw) per day (expressed as trifluoroacetic acid) derived from the parental benchmark dose lower confidence limit (BMDL20) of 8.6 mg/kg bw per day. This value is based on changes in thyroid hormones, specifically decreased thyroxine (T4) levels, observed in the extended one-generation reproductive toxicity study in rats. A standard uncertainty factor of 100 was applied to account for inter- and intra-species differences. An additional factor of 5 was applied to address remaining uncertainties, namely the absence of a long-term toxicity/carcinogenicity study and the potential for developmental immunotoxicity, given the lack of functional immunotoxicity testing for TFA during the developmental phase. In addition, an ARfD of 0.07 mg/kg bw (expressed as trifluoroacetic acid) was derived based on the same BMDL20 of 8.6 mg/kg bw per day, by applying a standard uncertainty factor of 100.