2. Academic Validation
  3. RIFM fragrance ingredient safety assessment, hexyl hexanoate, CAS Registry Number 6378-65-0

RIFM fragrance ingredient safety assessment, hexyl hexanoate, CAS Registry Number 6378-65-0

  • Food Chem Toxicol. 2020 Oct 15:144 Suppl 1:111635. doi: 10.1016/j.fct.2020.111635.
A M Api 1,  D Belsito 2,  S Biserta 1,  D Botelho 1,  M Bruze 3,  G A Burton Jr 4,  J Buschmann 5,  M A Cancellieri 1,  M L Dagli 6,  M Date 1,  W Dekant 7,  C Deodhar 1,  A D Fryer 8,  S Gadhia 1,  L Jones 1,  K Joshi 1,  A Lapczynski 1,  M Lavelle 1,  D C Liebler 9,  M Na 1,  D O'Brien 1,  A Patel 1,  T M Penning 10,  G Ritacco 1,  F Rodriguez-Ropero 1,  J Romine 1,  N Sadekar 1,  D Salvito 1,  T W Schultz 11,  F Siddiqi 1,  I G Sipes 12,  G Sullivan 13,  Y Thakkar 1,  Y Tokura 14,  S Tsang 1
Affiliations

Affiliations

  • 1 Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
  • 2 Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
  • 3 Malmo University Hospital, Department of Occupational & Environmental Dermatology, Sodra Forstadsgatan 101, Entrance 47, Malmo, SE, 20502, Sweden.
  • 4 School of Natural Resources & Environment, University of Michigan, Dana Building G110, 440 Church St., Ann Arbor, MI, 58109, USA.
  • 5 Fraunhofer Institute for Toxicology and Experimental Medicine, Nikolai-Fuchs-Strasse 1, 30625, Hannover, Germany.
  • 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 University of Pennsylvania, Perelman School of Medicine, Center of Excellence in Environmental Toxicology, 1316 Biomedical Research Building (BRB) II/III, 421 Curie Boulevard, Philadelphia, PA, 19104-3083, USA.
  • 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.
  • 13 Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA. Electronic address: gsullivan@rifm.org.
  • 14 Department of Dermatology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
PMID: 32781227 DOI: 10.1016/j.fct.2020.111635
Abstract

The existing information supports the use of this material as described in this safety assessment. Hexyl hexanoate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog hexyl isobutyrate (CAS # 2349-07-7) show that hexyl hexanoate is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to hexyl hexanoate is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for non-reactive Materials (900 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; hexyl hexanoate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; hexyl hexanoate was found not to be persistent, bioaccumulative, and toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.

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