Toxicological evaluation of 2-dodecylcyclobutanone, a unique radiolytic compound of palmitic acid.

This study was conducted to evaluate the toxic effects and potency of 2-dodecylcyclobutanone (2-dDCB), a unique compound derived from palmitic acid via irradiation. In a series of assays of bacterial reverse-mutation, in vitro chromosomal aberration, and in vivo micronucleus, negative responses were found by the treatment of 2-dDCB comparing vehicle control, dimethyl sulfoxide or corn oil. In the acute oral toxicity test, all of the mice administrated 2-dDCB survived, and there were no clinical and necropsy signs observed at any doses (0, 300, and 2000 mg/kg body weight) during the experimental period of 14 days. These results suggested that 2-dDCB is a relatively non-toxic substance with median lethality dose higher than 2000 mg/kg body weight. Moreover, there were no adverse effects noted in rats orally administrated 2-dDCB everyday via gavage for 28 days, even at the highest dose (2.0 mg/kg body weight/day) tested, which is 1000-times higher than the human daily intake of 2-dDCB estimated through an extreme exposure scenario. Overall, these results indicate that 2-dDCB is not likely to raise any human health concerns and irradiated foods containing palmitic acid can be recognized as safe for human consumption under the current international regulation systems for food irradiation.