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RIFM fragrance ingredient safety assessment, 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one, CAS registry number 13215-88-8

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 141.
Abstract

The existing information supports the use of this material as described in this safety assessment. 4-(2-Butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one is not genotoxic. Data on 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class I material, and... (More)

The existing information supports the use of this material as described in this safety assessment. 4-(2-Butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one is not genotoxic. Data on 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. The 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 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one is below the TTC (0.03 mg/kg/day and 1.4 mg/day, respectively). The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for reactive materials (64 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on data; 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one 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
Environmental safety, Genotoxicity, Local respiratory toxicity, Phototoxicity/photoallergenicity, Repeated dose, developmental, and reproductive toxicity, Skin sensitization
in
Food and Chemical Toxicology
volume
141
article number
111377
publisher
Elsevier
external identifiers
  • scopus:85084224808
  • pmid:32360215
ISSN
0278-6915
DOI
10.1016/j.fct.2020.111377
language
English
LU publication?
no
id
a670d191-ded5-4033-80ae-da00628a44de
date added to LUP
2020-05-26 07:52:45
date last changed
2024-04-03 08:12:29
@article{a670d191-ded5-4033-80ae-da00628a44de,
  abstract     = {{<p>The existing information supports the use of this material as described in this safety assessment. 4-(2-Butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one is not genotoxic. Data on 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one provide a calculated margin of exposure (MOE) &gt; 100 for the repeated dose toxicity endpoint. The 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 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one is below the TTC (0.03 mg/kg/day and 1.4 mg/day, respectively). The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for reactive materials (64 μg/cm<sup>2</sup>); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on data; 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one 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     = {{Environmental safety; Genotoxicity; Local respiratory toxicity; Phototoxicity/photoallergenicity; Repeated dose, developmental, and reproductive toxicity; Skin sensitization}},
  language     = {{eng}},
  month        = {{04}},
  publisher    = {{Elsevier}},
  series       = {{Food and Chemical Toxicology}},
  title        = {{RIFM fragrance ingredient safety assessment, 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one, CAS registry number 13215-88-8}},
  url          = {{http://dx.doi.org/10.1016/j.fct.2020.111377}},
  doi          = {{10.1016/j.fct.2020.111377}},
  volume       = {{141}},
  year         = {{2020}},
}