RIFM fragrance ingredient safety assessment, octyl isobutyrate, CAS Registry Number 109-15-9
(2022) In Food and Chemical Toxicology 161.- Abstract
The existing information supports the use of this material as described in this safety assessment. Octyl isobutyrate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog hexyl isobutyrate (CAS # 2349-07-7) show that octyl isobutyrate is not expected to be genotoxic. Data on analog propyl (2S)-2-(1,1-dimethylpropoxy)-propanoate (CAS # 319002-92-1) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose and reproductive toxicity endpoints. Data from analog hexyl 2-methylbutyrate (CAS # 10032-15-2) provided octyl isobutyrate a No Expected Sensitization... (More)
The existing information supports the use of this material as described in this safety assessment. Octyl isobutyrate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog hexyl isobutyrate (CAS # 2349-07-7) show that octyl isobutyrate is not expected to be genotoxic. Data on analog propyl (2S)-2-(1,1-dimethylpropoxy)-propanoate (CAS # 319002-92-1) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose and reproductive toxicity endpoints. Data from analog hexyl 2-methylbutyrate (CAS # 10032-15-2) provided octyl isobutyrate a No Expected Sensitization Induction Level (NESIL) of 7000 μg/cm2 for the skin sensitization endpoint. Octyl isobutyrate is not expected to be phototoxic/photoallergenic based on ultraviolet/visible (UV/Vis) spectra. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure to is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; octyl isobutyrate 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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- author
- publishing date
- 2022-03
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Food and Chemical Toxicology
- volume
- 161
- article number
- 112870
- publisher
- Elsevier
- external identifiers
-
- scopus:85125764865
- pmid:35183650
- ISSN
- 0278-6915
- DOI
- 10.1016/j.fct.2022.112870
- language
- English
- LU publication?
- no
- id
- 73da6c56-d745-440b-941e-23def77fd61b
- date added to LUP
- 2022-04-27 15:40:47
- date last changed
- 2024-09-22 13:35:22
@article{73da6c56-d745-440b-941e-23def77fd61b, abstract = {{<p>The existing information supports the use of this material as described in this safety assessment. Octyl isobutyrate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog hexyl isobutyrate (CAS # 2349-07-7) show that octyl isobutyrate is not expected to be genotoxic. Data on analog propyl (2S)-2-(1,1-dimethylpropoxy)-propanoate (CAS # 319002-92-1) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose and reproductive toxicity endpoints. Data from analog hexyl 2-methylbutyrate (CAS # 10032-15-2) provided octyl isobutyrate a No Expected Sensitization Induction Level (NESIL) of 7000 μg/cm<sup>2</sup> for the skin sensitization endpoint. Octyl isobutyrate is not expected to be phototoxic/photoallergenic based on ultraviolet/visible (UV/Vis) spectra. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure to is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; octyl isobutyrate 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.</p>}}, author = {{Api, A. M. and Belsito, D. and Botelho, D. and Bruze, M. and Burton, G. A. and Cancellieri, M. A. and Chon, H. 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, octyl isobutyrate, CAS Registry Number 109-15-9}}, url = {{http://dx.doi.org/10.1016/j.fct.2022.112870}}, doi = {{10.1016/j.fct.2022.112870}}, volume = {{161}}, year = {{2022}}, }