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

A M Api; D Belsito; S Bhatia; M Bruze; P Calow; M L Dagli; W Dekant; A D Fryer; L Kromidas; S La Cava; J F Lalko; A Lapczynski; D C Liebler; Y Miyachi; V T Politano; G Ritacco; D Salvito; T W Schultz; J Shen; I G Sipes; B Wall; D K Wilcox

doi:10.1016/j.fct.2015.12.013

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

Food Chem Toxicol. 2016 Nov:97S:S25-S37. doi: 10.1016/j.fct.2015.12.013. Epub 2015 Dec 17.

Authors

A M Api¹, D Belsito², S Bhatia³, M Bruze⁴, P Calow⁵, M L Dagli⁶, W Dekant⁷, A D Fryer⁸, L Kromidas³, S La Cava³, J F Lalko³, A Lapczynski³, D C Liebler⁹, Y Miyachi¹⁰, V T Politano³, G Ritacco³, D Salvito³, T W Schultz¹¹, J Shen³, I G Sipes¹², B Wall³, D K Wilcox³

Affiliations

¹ Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA. Electronic address: AApi@rifm.org.
² Member RIFM Expert Panel, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY 10032, USA.
³ Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA.
⁴ Member RIFM Expert Panel, Malmo University Hospital, Department of Occupational & Environmental Dermatology, Sodra Forstadsgatan 101, Entrance 47, Malmo SE-20502, Sweden.
⁵ Member RIFM Expert Panel, Humphrey School of Public Affairs, University of Minnesota, 301 19th Avenue South, Minneapolis, MN 55455, USA.
⁶ Member RIFM Expert Panel, University of Sao Paulo, School of Veterinary Medicine and Animal Science, Department of Pathology, Av. Prof. Dr. Orlando Marques de Paiva, 87, Sao Paulo CEP 05508-900, Brazil.
⁷ Member RIFM Expert Panel, University of Wuerzburg, Department of Toxicology, Versbacher Str. 9, 97078 Würzburg, Germany.
⁸ Member RIFM Expert Panel, Oregon Health Science University, 3181 SW Sam Jackson Park Rd., Portland, OR 97239, USA.
⁹ Member RIFM Expert Panel, Vanderbilt University School of Medicine, Department of Biochemistry, Center in Molecular Toxicology, 638 Robinson Research Building, 2200 Pierce Avenue, Nashville, TN 37232-0146, USA.
¹⁰ Member RIFM Expert Panel, Department of Dermatology, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan.
¹¹ Member RIFM Expert Panel, The University of Tennessee, College of Veterinary Medicine, Department of Comparative Medicine, 2407 River Dr., Knoxville, TN 37996-4500, USA.
¹² Member RIFM Expert Panel, Department of Pharmacology, University of Arizona, College of Medicine, 1501 North Campbell Avenue, P.O. Box 245050, Tucson, AZ 85724-5050, USA.

PMID: 26702986
DOI: 10.1016/j.fct.2015.12.013

Abstract

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.

Keywords: Environmental safety; Genotoxicity; Local respiratory toxicity; Phototoxicity/photoallergenicity; Repeated dose; Reproductive and developmental toxicity; Skin sensitization.

Publication types

Review

MeSH terms

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
Eugenol / chemistry
Eugenol / toxicity*
No-Observed-Adverse-Effect Level
Perfume / chemistry
Perfume / toxicity*
Rats
Risk Assessment
Toxicity Tests / methods*

Substances

Anti-Infective Agents
Perfume
Eugenol