RIFM fragrance ingredient safety assessment, Fenchyl alcohol, CAS registry number 1632-73-1

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; J Shen; T W Schultz; I G Sipes; B Wall; D K Wilcox

doi:10.1016/j.fct.2015.08.022

RIFM fragrance ingredient safety assessment, Fenchyl alcohol, CAS registry number 1632-73-1

Food Chem Toxicol. 2015 Oct:84 Suppl:S25-32. doi: 10.1016/j.fct.2015.08.022. Epub 2015 Sep 2.

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, J Shen³, T W Schultz¹¹, 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: [email protected].
² 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 Malmo University Hospital, Department of Occupational & Environmental Dermatology, Sodra Forstadsgatan 101, Entrance 47, Malmo SE-20502, Sweden.
⁵ University of Nebraska Lincoln, 230 Whittier Research Center, Lincoln, NE 68583-0857, USA.
⁶ 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 University of Wuerzburg, Department of Toxicology, Versbacher Str. 9, 97078 Würzburg, Germany.
⁸ Oregon Health Science University, 3181 SW Sam Jackson Park Rd., Portland, OR 97239 USA.
⁹ 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 Department of Dermatology, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan.
¹¹ The University of Tennessee, College of Veterinary Medicine, Department of Comparative Medicine, 2407 River Dr., Knoxville, TN 37996- 4500, USA.
¹² Department of Pharmacology, University of Arizona, College of Medicine, 1501 North Campbell Avenue, P.O. Box 245050, Tucson, AZ 85724-5050, USA.

PMID: 26342767
DOI: 10.1016/j.fct.2015.08.022

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. Repeated dose toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 15 mg/kg/day. A gavage 13-week subchronic toxicity study conducted in rats on a suitable read across analog resulted in a MOE of 10,714 while assuming 100% absorption from skin contact and inhalation. A MOE of >100 is deemed acceptable.

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

Publication types

Review

MeSH terms

Animals
Camphanes
Consumer Product Safety
DNA Damage / drug effects
Dose-Response Relationship, Drug
Drug Evaluation, Preclinical
Endpoint Determination
Humans
No-Observed-Adverse-Effect Level
Norbornanes / chemistry
Norbornanes / toxicity*
Perfume / chemistry
Perfume / toxicity*
Rats
Risk Assessment
Toxicity Tests*

Substances

Camphanes
Norbornanes
Perfume
fenchol