RIFM fragrance ingredient safety assessment, linalyl isobutyrate, CAS registry number 78-35-3

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.2015.09.013

RIFM fragrance ingredient safety assessment, linalyl isobutyrate, CAS registry number 78-35-3

Food Chem Toxicol. 2015 Oct:84 Suppl:S76-87. doi: 10.1016/j.fct.2015.09.013. Epub 2015 Sep 28.

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: [email protected].
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, University of Nebraska Lincoln, 230 Whittier Research Center, Lincoln, NE 68583-0857, 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: 26423640
DOI: 10.1016/j.fct.2015.09.013

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 based on the Threshold of Toxicological Concern (TTC) of 0.03 mg/kg/day for a Cramer Class I material. The estimated systemic exposure is determined to be below this value while assuming 80% absorption from skin contact and 100% from inhalation. A systemic exposure below the TTC value is acceptable.

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

Publication types

Review

MeSH terms

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

Substances

Butyrates
Monoterpenes
Perfume
3,7-dimethyl-1,6-octadien-3-yl isobutyrate