RIFM fragrance ingredient safety assessment, ethyl lactate, CAS registry number 97-64-3

A M Api; D Belsito; S Biserta; D Botelho; M Bruze; G A Burton Jr; J Buschmann; M A Cancellieri; M L Dagli; M Date; W Dekant; C Deodhar; A D Fryer; S Gadhia; L Jones; K Joshi; M Kumar; A Lapczynski; M Lavelle; I Lee; D C Liebler; H Moustakas; M Na; T M Penning; G Ritacco; J Romine; N Sadekar; T W Schultz; D Selechnik; F Siddiqi; I G Sipes; G Sullivan; Y Thakkar; Y Tokura

doi:10.1016/j.fct.2020.111741

RIFM fragrance ingredient safety assessment, ethyl lactate, CAS registry number 97-64-3

Food Chem Toxicol. 2020 Dec 15:146 Suppl 1:111741. doi: 10.1016/j.fct.2020.111741. Epub 2020 Sep 11.

Authors

A M Api¹, D Belsito², S Biserta¹, D Botelho¹, M Bruze³, G A Burton Jr⁴, J Buschmann⁵, M A Cancellieri¹, M L Dagli⁶, M Date¹, W Dekant⁷, C Deodhar¹, A D Fryer⁸, S Gadhia¹, L Jones¹, K Joshi¹, M Kumar¹, A Lapczynski¹, M Lavelle¹, I Lee¹, D C Liebler⁹, H Moustakas¹, M Na¹, T M Penning¹⁰, G Ritacco¹, J Romine¹, N Sadekar¹, T W Schultz¹¹, D Selechnik¹, F Siddiqi¹, I G Sipes¹², G Sullivan¹³, Y Thakkar¹, Y Tokura¹⁴

Affiliations

¹ Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
² Member Expert Panel, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
³ Member Expert Panel, Malmo University Hospital, Department of Occupational & Environmental Dermatology, Sodra Forstadsgatan 101, Entrance 47, Malmo, SE, 20502, Sweden.
⁴ Member Expert Panel, School of Natural Resources & Environment, University of Michigan, Dana Building G110, 440 Church St., Ann Arbor, MI, 58109, USA.
⁵ Member Expert Panel, Fraunhofer Institute for Toxicology and Experimental Medicine, Nikolai-Fuchs-Strasse 1, 30625, Hannover, Germany.
⁶ Member 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 Expert Panel, University of Wuerzburg, Department of Toxicology, Versbacher Str. 9, 97078, Würzburg, Germany.
⁸ Member Expert Panel, Oregon Health Science University, 3181 SW Sam Jackson Park Rd., Portland, OR, 97239, USA.
⁹ Member 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 of Expert Panel, 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 Member Expert Panel, The University of Tennessee, College of Veterinary Medicine, Department of Comparative Medicine, 2407 River Dr., Knoxville, TN 37996- 4500, USA.
¹² Member Expert Panel, 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: [email protected].
¹⁴ Member Expert Panel, The Journal of Dermatological Science (JDS), Editor-in-Chief, Professor and Chairman, Department of Dermatology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan.

PMID: 32926936
DOI: 10.1016/j.fct.2020.111741

Abstract

The existing information supports the use of this material as described in this safety assessment. Ethyl lactate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data on ethyl lactate show that ethyl lactate is not genotoxic and provided a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity, reproductive toxicity, and local respiratory endpoints. Data from ethyl lactate and additional material ethyl (L)-lactate (CAS # 687-47-8) show that there are no safety concerns for ethyl lactate for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; ethyl lactate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; ethyl lactate 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.

MeSH terms

Animals
Databases, Chemical
Dermatitis, Phototoxic
Endpoint Determination
Humans
Lactates / chemistry
Lactates / toxicity*
Mutagenicity Tests
Odorants / analysis
Perfume / chemistry
Perfume / toxicity*
Plants / drug effects
Reproduction / drug effects
Risk Assessment
Skin / drug effects
Toxicity Tests

Substances

Lactates
Perfume
ethyl lactate