RIFM fragrance ingredient safety assessment, α-Ionone, CAS Registry Number 127-41-3

• Published in: Food and chemical toxicology Vol. 97; pp. S1 - S10
• 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; Consumer Product Safety; Developmental and reproductive toxicity; DNA Damage - drug effects; Dose-Response Relationship, Drug; Drug Evaluation, Preclinical; Endpoint Determination; Environmental safety; Genotoxicity; Local respiratory toxicity; No-Observed-Adverse-Effect Level; Norisoprenoids - chemistry; Norisoprenoids - toxicity; Perfume - chemistry; Perfume - toxicity; Phototoxicity and photoallergenicity; Rats; Repeated dose; Risk Assessment; Skin sensitization; Toxicity Tests - methods; Skin sensitization; Local respiratory toxicity; Genotoxicity; Repeated dose; Developmental and reproductive toxicity; Environmental safety; Phototoxicity and photoallergenicity
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2015.12.010

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 10 mg/kg/day. A dietary 90-day subchronic toxicity study conducted in rats resulted in a MOE of 182 while assuming 100% absorption from skin contact and inhalation. A MOE of >100 is deemed acceptable. •α-Ionone 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.