RIFM fragrance ingredient safety assessment, isoeugenol, CAS Registry Number 97-54-1

The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, as well as, environmental safety. Repeated dose toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 37.5 mg/kg/day. A gavage 13-week subchronic toxicity study conducted in mice resulted in a MOE of 5769 while considering 38.4% absorption from skin contact and 100% from inhalation. A MOE of >100 is deemed acceptable. •Isoeugenol safety assessment based on RIFM's criteria.•Safety assessment based on 7 Human health endpoints plus environmental.•Repeated dose toxicity was determined to have the most conservative NO[A]EL.•An acceptable MOE was obtained.