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RIFM fragrance ingredient safety assessment, p-tolualdehyde, CAS Registry Number 104-87-0

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(S1).
Abstract

The existing information supports the use of this material as described in this safety assessment. p-Tolualdehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, and environmental safety. Data from read-across analog benzaldehyde (CAS # 100-52-7) show that p-tolualdehyde is not expected to be genotoxic. Data from read-across analog cuminaldehyde (CAS # 122-03-2) provided p-tolualdehyde a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm2 for the skin sensitization endpoint. The repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity endpoints were... (More)

The existing information supports the use of this material as described in this safety assessment. p-Tolualdehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, and environmental safety. Data from read-across analog benzaldehyde (CAS # 100-52-7) show that p-tolualdehyde is not expected to be genotoxic. Data from read-across analog cuminaldehyde (CAS # 122-03-2) provided p-tolualdehyde a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm2 for the skin sensitization endpoint. The repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity endpoints were completed using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to p-tolualdehyde is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on data from read-across analog 4-ethylbenzaldehyde (CAS # 4748-78-1); p-tolualdehyde is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; p-tolualdehyde 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
keywords
Developmental and reproductive toxicity, Environmental safety, Genotoxicity, Local respiratory toxicity, Phototoxicity/photoallergenicity, Repeated dose, Skin sensitization
in
Food and Chemical Toxicology
volume
149
issue
S1
article number
111982
publisher
Elsevier
external identifiers
  • scopus:85107711889
  • pmid:33454360
  • scopus:85100590817
ISSN
0278-6915
DOI
10.1016/j.fct.2021.111982
language
English
LU publication?
no
id
dc2c255c-bb51-4a53-a079-606b23e782e2
date added to LUP
2021-02-26 09:26:09
date last changed
2024-06-13 07:25:57
@article{dc2c255c-bb51-4a53-a079-606b23e782e2,
  abstract     = {{<p>The existing information supports the use of this material as described in this safety assessment. p-Tolualdehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, and environmental safety. Data from read-across analog benzaldehyde (CAS # 100-52-7) show that p-tolualdehyde is not expected to be genotoxic. Data from read-across analog cuminaldehyde (CAS # 122-03-2) provided p-tolualdehyde a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm<sup>2</sup> for the skin sensitization endpoint. The repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity endpoints were completed using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to p-tolualdehyde is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on data from read-across analog 4-ethylbenzaldehyde (CAS # 4748-78-1); p-tolualdehyde is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; p-tolualdehyde 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}},
  keywords     = {{Developmental and reproductive toxicity; Environmental safety; Genotoxicity; Local respiratory toxicity; Phototoxicity/photoallergenicity; Repeated dose; Skin sensitization}},
  language     = {{eng}},
  month        = {{03}},
  number       = {{S1}},
  publisher    = {{Elsevier}},
  series       = {{Food and Chemical Toxicology}},
  title        = {{RIFM fragrance ingredient safety assessment, p-tolualdehyde, CAS Registry Number 104-87-0}},
  url          = {{http://dx.doi.org/10.1016/j.fct.2021.111982}},
  doi          = {{10.1016/j.fct.2021.111982}},
  volume       = {{149}},
  year         = {{2021}},
}