Risk Assessment of Isoeugenol in Food Based on Benchmark Dose-Response Modeling.

Isoeugenol has recently been evaluated as possibly carcinogenic (Group 2B) by the WHO International Agency for Research on Cancer (IARC). In light of this evaluation, an updated risk assessment of this common food constituent was conducted using the benchmark dose (BMD) approach as recommended by the European Food Safety Authority (EFSA) for point of departure (POD) determination, as an alternative to the no observed adverse effect level (NOAEL). This approach was specifically chosen, as for the relevant neoplastic endpoints only lowest observed adverse effect level (LOAEL) values are available. The toxicological endpoint from the animal studies with the most conservative BMD lower confidence limit (BMDL) value was identified. Using the obtained BMDL value of 8 mg/kg body weight/day as POD, an acceptable daily intake (ADI) of 16 µg/kg body weight/day was obtained, which-despite being more conservative than previous approaches-is still clearly above the estimated daily exposure level to isoeugenol in the USA and in Europe. These results confirm a low risk of the estimated daily exposure levels of isoeugenol.