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RIFM fragrance ingredient safety assessment, 5-hydroxy-7-decenoic acid δ-lactone, CAS Registry Number 25524-95-2

Api, A. M. ; Belsito, D. ; Botelho, D. ; Bruze, M. LU ; Burton, G. A. ; Buschmann, J. ; Cancellieri, M. A. ; Dagli, M. L. ; Date, M. and Dekant, W. , et al. (2022) In Food and Chemical Toxicology 161.
Abstract

The existing information supports the use of this material as described in this safety assessment. 5-Hydroxy-7-decenoic acid δ-lactone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across material tetrahydro-6-(3-pentenyl)-2H-pyran-2-one (CAS # 32764-98-0) show that 5-hydroxy-7-decenoic acid δ-lactone 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 5-hydroxy-7-decenoic acid δ-lactone is below the TTC (0.03... (More)

The existing information supports the use of this material as described in this safety assessment. 5-Hydroxy-7-decenoic acid δ-lactone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across material tetrahydro-6-(3-pentenyl)-2H-pyran-2-one (CAS # 32764-98-0) show that 5-hydroxy-7-decenoic acid δ-lactone 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 5-hydroxy-7-decenoic acid δ-lactone is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data show that there are no safety concerns for 5-hydroxy-7-decenoic acid δ-lactone for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 5-hydroxy-7-decenoic acid δ-lactone is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 5-Hydroxy-7-decenoic acid δ-lactone 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
161
article number
112853
publisher
Elsevier
external identifiers
  • pmid:35150761
  • scopus:85124584998
ISSN
0278-6915
DOI
10.1016/j.fct.2022.112853
language
English
LU publication?
no
id
52e1233f-ffff-44c9-9bd1-39573b4c8dae
date added to LUP
2022-04-13 14:39:49
date last changed
2024-06-04 15:23:57
@article{52e1233f-ffff-44c9-9bd1-39573b4c8dae,
  abstract     = {{<p>The existing information supports the use of this material as described in this safety assessment. 5-Hydroxy-7-decenoic acid δ-lactone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across material tetrahydro-6-(3-pentenyl)-2H-pyran-2-one (CAS # 32764-98-0) show that 5-hydroxy-7-decenoic acid δ-lactone 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 5-hydroxy-7-decenoic acid δ-lactone is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data show that there are no safety concerns for 5-hydroxy-7-decenoic acid δ-lactone for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 5-hydroxy-7-decenoic acid δ-lactone is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 5-Hydroxy-7-decenoic acid δ-lactone 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 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 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}},
  publisher    = {{Elsevier}},
  series       = {{Food and Chemical Toxicology}},
  title        = {{RIFM fragrance ingredient safety assessment, 5-hydroxy-7-decenoic acid δ-lactone, CAS Registry Number 25524-95-2}},
  url          = {{http://dx.doi.org/10.1016/j.fct.2022.112853}},
  doi          = {{10.1016/j.fct.2022.112853}},
  volume       = {{161}},
  year         = {{2022}},
}