The
European Food Safety Authority (EFSA) and the
United States Food and Drug Administration (FDA) have evaluated TBHQ and determined that it is safe to consume at the concentration allowed in foods. The FDA and European Union At very high doses, it has some negative health effects on lab animals, such as producing precursors to stomach tumors and damage to DNA. A number of studies have shown that prolonged exposure to very high doses of TBHQ may be
carcinogenic, especially for stomach tumors. Other studies, however, have shown opposite effects, including inhibition against
HCA-induced carcinogenesis (by depression of metabolic activation) for TBHQ and other phenolic antioxidants (TBHQ was one of several, and not the most potent) and reduction of nitrosamine-induced carcinogenesis (likely due to phase-II enzyme induction via
Nrf2). The EFSA considers TBHQ to be noncarcinogenic. In addition, TBHQ has been identified by
high-throughput screening as having potential
immunotoxic effects in 2021. It was previously reported in 2014 that TBHQ enhances allergy response in mice by promoting Th2 cells through Nrf2. Experiments on its genotoxicity at high doses are inconsistent. Its oxidized form TBBQ may be responsible for some toxic effects. There exists a wide margin of safety between food-additive doses and doses used in studies. ==References==