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RIFM fragrance ingredient safety assessment, 4-methylpentanoic acid, CAS Registry Number 646-07-1

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 144.
Abstract

The existing information supports the use of this material as described in this safety assessment. 4-Methylpentanoic acid was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 2-ethylbutyric acid (CAS # 88-09-5) show that 4-methylpentanoic acid is not expected to be genotoxic and 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 non-reactive materials (900 μg/cm2); exposure is below the DST. The... (More)

The existing information supports the use of this material as described in this safety assessment. 4-Methylpentanoic acid was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 2-ethylbutyric acid (CAS # 88-09-5) show that 4-methylpentanoic acid is not expected to be genotoxic and 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 non-reactive materials (900 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 4-methylpentanoic acid 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 4-methylpentanoic acid is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 4-methylpentanoic acid 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
144
article number
111456
publisher
Elsevier
external identifiers
  • pmid:32640362
  • scopus:85087931538
ISSN
0278-6915
DOI
10.1016/j.fct.2020.111456
language
English
LU publication?
no
id
0fa71b89-6a4e-41ce-916e-4d6696338639
date added to LUP
2020-07-30 14:48:46
date last changed
2024-04-03 12:31:36
@article{0fa71b89-6a4e-41ce-916e-4d6696338639,
  abstract     = {{<p>The existing information supports the use of this material as described in this safety assessment. 4-Methylpentanoic acid was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 2-ethylbutyric acid (CAS # 88-09-5) show that 4-methylpentanoic acid is not expected to be genotoxic and 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 non-reactive materials (900 μg/cm<sup>2</sup>); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 4-methylpentanoic acid 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 4-methylpentanoic acid is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 4-methylpentanoic acid 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 Lapczynski, A. and Lavelle, M. and Liebler, D. C. and Na, M. and O'Brien, D. and Patel, A. and Penning, T. M. and Ritacco, G. and Rodriguez-Ropero, F. and Romine, J. and Sadekar, N. and Salvito, D. and Schultz, T. W. and Siddiqi, F. and Sipes, I. G. and Sullivan, G. and Thakkar, Y. and Tokura, Y. and Tsang, S.}},
  issn         = {{0278-6915}},
  language     = {{eng}},
  month        = {{07}},
  publisher    = {{Elsevier}},
  series       = {{Food and Chemical Toxicology}},
  title        = {{RIFM fragrance ingredient safety assessment, 4-methylpentanoic acid, CAS Registry Number 646-07-1}},
  url          = {{http://dx.doi.org/10.1016/j.fct.2020.111456}},
  doi          = {{10.1016/j.fct.2020.111456}},
  volume       = {{144}},
  year         = {{2020}},
}