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

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 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.

• Authors: A M Api, D Belsito, 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, 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
• Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association (Food Chem Toxicol) Vol. 161 Suppl 1 Pg. 112853 (Mar 2022) ISSN: 1873-6351 [Electronic] England
• PMID: 35150761 (Publication Type: Journal Article)
• Copyright: Copyright © 2022 Elsevier Ltd. All rights reserved.

Chemical References

• Lactones

Topics

• Humans
• Lactones (toxicity)
• Mutagenicity Tests
• Odorants
• Toxicity Tests