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

Api, A. M. ; Belsito, D. ; Biserta, S. ; Botelho, D. ; Bruze, M. LU ; Burton, G. A. ; Buschmann, J. ; Cancellieri, M. A. ; Dagli, M. L. and Date, M. , et al. (2020) In Food and Chemical Toxicology 146.
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... (More)

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.

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publishing date
type
Contribution to journal
publication status
published
subject
in
Food and Chemical Toxicology
volume
146
article number
111741
publisher
Elsevier
external identifiers
  • pmid:32926936
  • scopus:85091205767
ISSN
0278-6915
DOI
10.1016/j.fct.2020.111741
language
English
LU publication?
no
id
9e5df257-c520-4c1f-8755-65e942a159e7
date added to LUP
2020-10-26 09:46:08
date last changed
2022-07-12 09:19:38
@article{9e5df257-c520-4c1f-8755-65e942a159e7,
  abstract     = {{<p>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) &gt; 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 &lt;1.</p>}},
  author       = {{Api, A. M. and Belsito, D. and Biserta, S. and Botelho, D. and Bruze, M. and Burton, G. A. and Buschmann, J. and Cancellieri, M. A. and Dagli, M. L. and Date, M. and Dekant, W. and Deodhar, C. and Fryer, A. D. and Gadhia, S. and Jones, L. and Joshi, K. and Kumar, M. and Lapczynski, A. and Lavelle, M. and Lee, I. and Liebler, D. C. and Moustakas, H. and Na, M. and Penning, T. M. and Ritacco, G. and Romine, J. and Sadekar, N. and Schultz, T. W. and Selechnik, D. and Siddiqi, F. and Sipes, I. G. and Sullivan, G. and Thakkar, Y. and Tokura, Y.}},
  issn         = {{0278-6915}},
  language     = {{eng}},
  month        = {{09}},
  publisher    = {{Elsevier}},
  series       = {{Food and Chemical Toxicology}},
  title        = {{RIFM fragrance ingredient safety assessment, ethyl lactate, CAS registry number 97-64-3}},
  url          = {{http://dx.doi.org/10.1016/j.fct.2020.111741}},
  doi          = {{10.1016/j.fct.2020.111741}},
  volume       = {{146}},
  year         = {{2020}},
}