RIFM fragrance ingredient safety assessment, Eugenol, CAS Registry Number 97-53-0

• Published in: Food and chemical toxicology Vol. 97; pp. S25 - S37
• Main Authors: Api, A.M., Belsito, D., Bhatia, S., Bruze, M., Calow, P., Dagli, M.L., Dekant, W., Fryer, A.D., Kromidas, L., La Cava, S., Lalko, J.F., Lapczynski, A., Liebler, D.C., Miyachi, Y., Politano, V.T., Ritacco, G., Salvito, D., Schultz, T.W., Shen, J., Sipes, I.G., Wall, B., Wilcox, D.K.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.11.2016
• Subjects: Animals; Anti-Infective Agents - chemistry; Anti-Infective Agents - toxicity; Consumer Product Safety; DNA Damage - drug effects; Dose-Response Relationship, Drug; Drug Evaluation, Preclinical; Endpoint Determination; Environmental safety; Eugenol - chemistry; Eugenol - toxicity; Genotoxicity; Local respiratory toxicity; No-Observed-Adverse-Effect Level; Perfume - chemistry; Perfume - toxicity; Phototoxicity/photoallergenicity; Rats; Repeated dose; Reproductive and developmental toxicity; Risk Assessment; Skin sensitization; Toxicity Tests - methods; Reproductive and developmental toxicity; Skin sensitization; Local respiratory toxicity; Genotoxicity; Phototoxicity/photoallergenicity; Repeated dose; Environmental safety
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2015.12.013

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. Reproductive toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 230 mg/kg/day. A gavage multigenerational continuous breeding study conducted in rats on a suitable read across analog resulted in a MOE of 12,105 while considering 22.6% absorption from skin contact and 100% from inhalation. A MOE of >100 is deemed acceptable. •Eugenol safety assessment based on RIFM's criteria.•Safety assessment based on 7 Human health endpoints plus environmental.•Reproductive toxicity was determined to have the most conservative NO[A]EL.•An acceptable MOE was obtained.