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RIFM fragrance ingredient safety assessment, glyceryl monooleate, CAS Registry Number 111-03-5

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. (2021) In Food and Chemical Toxicology 149.
Abstract

The existing information supports the use of this material as described in this safety assessment. Glyceryl monooleate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that glyceryl monooleate is not genotoxic. Data on glyceryl monooleate provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints. The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for reactive materials (64 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based... (More)

The existing information supports the use of this material as described in this safety assessment. Glyceryl monooleate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that glyceryl monooleate is not genotoxic. Data on glyceryl monooleate provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints. The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for reactive materials (64 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; glyceryl monooleate is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to glyceryl monooleate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; glyceryl monooleate 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 (VoU) 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
keywords
Environmental safety, Genotoxicity, Local respiratory toxicity, Phototoxicity/photoallergenicity, Repeated dose, developmental, and reproductive toxicity, Skin sensitization
in
Food and Chemical Toxicology
volume
149
article number
111992
publisher
Elsevier
external identifiers
  • scopus:85100027607
  • pmid:33460703
ISSN
0278-6915
DOI
10.1016/j.fct.2021.111992
language
English
LU publication?
no
id
5c4c17e7-3163-48f3-943f-c1b057103e6f
date added to LUP
2021-02-10 09:17:22
date last changed
2024-05-30 06:30:36
@article{5c4c17e7-3163-48f3-943f-c1b057103e6f,
  abstract     = {{<p>The existing information supports the use of this material as described in this safety assessment. Glyceryl monooleate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that glyceryl monooleate is not genotoxic. Data on glyceryl monooleate provide a calculated margin of exposure (MOE) &gt; 100 for the repeated dose toxicity and reproductive toxicity endpoints. The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for reactive materials (64 μg/cm<sup>2</sup>); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; glyceryl monooleate is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to glyceryl monooleate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; glyceryl monooleate 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 (VoU) 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}},
  keywords     = {{Environmental safety; Genotoxicity; Local respiratory toxicity; Phototoxicity/photoallergenicity; Repeated dose, developmental, and reproductive toxicity; Skin sensitization}},
  language     = {{eng}},
  month        = {{01}},
  publisher    = {{Elsevier}},
  series       = {{Food and Chemical Toxicology}},
  title        = {{RIFM fragrance ingredient safety assessment, glyceryl monooleate, CAS Registry Number 111-03-5}},
  url          = {{http://dx.doi.org/10.1016/j.fct.2021.111992}},
  doi          = {{10.1016/j.fct.2021.111992}},
  volume       = {{149}},
  year         = {{2021}},
}