RIFM fragrance ingredient safety assessment, 3,4,4a,5,8,8a(Or 3,4,4a,7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran, CAS Registry Number 72429-08-4

Api, A. M.; Belsito, D.; Biserta, S.; Botelho, D.; Bruze, M.; Burton, G. A.; Buschmann, J.; Cancellieri, M. A.; Dagli, M. L.; Date, M.; Dekant, W.; Deodhar, C.; Fryer, A. D.; Gadhia, S.; Jones, L.; Joshi, K.; Kumar, M.; Lapczynski, A.; Lavelle, M.; Lee, I.; Liebler, D. C.; Moustakas, H.; Na, M.; Penning, T. M.; Ritacco, G.; Romine, J.; Sadekar, N.; Schultz, T. W.; Selechnik, D.; Siddiqi, F.; Sipes, I. G.; Sullivan, G.; Thakkar, Y.; Tokura, Y.

RIFM fragrance ingredient safety assessment, 3,4,4a,5,8,8a(Or 3,4,4a,7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran, CAS Registry Number 72429-08-4

Mark

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.

Abstract: The existing information supports the use of this material as described in this safety assessment. 3,4,4a,5,8,8a (Or 3,4,4a,7,8,8a)-Hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class III material, and the exposure to 3,4,4a, 5,8,8a (Or 3,4,4a,... (More); The existing information supports the use of this material as described in this safety assessment. 3,4,4a,5,8,8a (Or 3,4,4a,7,8,8a)-Hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class III material, and the exposure to 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). 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; 3,4,4a, 5,8,8a (Or 3,4,4a,7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran 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.
(Less)

Please use this url to cite or link to this publication: https://lup.lub.lu.se/record/a0a8e60e-5509-4e54-8b17-88ff6fc99d9e

author

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. (More)

Api, A. M. ; Belsito, D. ; Biserta, S. ; Botelho, D. ; Bruze, M. ^LU ; Burton, G. A. ; Buschmann, J. ; Cancellieri, M. A. ; Dagli, M. L. ; Date, M. ; Dekant, W. ; Deodhar, C. ; Fryer, A. D. ; Gadhia, S. ; Jones, L. ; Joshi, K. ; Kumar, M. ; Lapczynski, A. ; Lavelle, M. ; Lee, I. ; Liebler, D. C. ; Moustakas, H. ; Na, M. ; Penning, T. M. ; Ritacco, G. ; Romine, J. ; Sadekar, N. ; Schultz, T. W. ; Selechnik, D. ; Siddiqi, F. ; Sipes, I. G. ; Sullivan, G. ; Thakkar, Y. and Tokura, Y. (Less)

publishing date

2021

type

Contribution to journal

publication status

published

subject

Pharmacology and Toxicology

keywords

Environmental Safety, Genotoxicity, Local Respiratory Toxicity, Phototoxicity/Photoallergenicity, Repeated Dose, Developmental, and Reproductive Toxicity, Skin Sensitization

in

Food and Chemical Toxicology

volume

149

article number

111885

publisher

Elsevier

external identifiers

pmid:33249051
scopus:85097472587

ISSN

0278-6915

DOI

10.1016/j.fct.2020.111885

language

English

LU publication?

no

id

a0a8e60e-5509-4e54-8b17-88ff6fc99d9e

date added to LUP

2020-12-23 10:01:06

date last changed

2024-03-20 22:33:15

@article{a0a8e60e-5509-4e54-8b17-88ff6fc99d9e,
  abstract     = {{<p>The existing information supports the use of this material as described in this safety assessment. 3,4,4a,5,8,8a (Or 3,4,4a,7,8,8a)-Hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class III material, and the exposure to 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). 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; 3,4,4a, 5,8,8a (Or 3,4,4a,7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran 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 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}},
  keywords     = {{Environmental Safety; Genotoxicity; Local Respiratory Toxicity; Phototoxicity/Photoallergenicity; Repeated Dose, Developmental, and Reproductive Toxicity; Skin Sensitization}},
  language     = {{eng}},
  publisher    = {{Elsevier}},
  series       = {{Food and Chemical Toxicology}},
  title        = {{RIFM fragrance ingredient safety assessment, 3,4,4a,5,8,8a(Or 3,4,4a,7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran, CAS Registry Number 72429-08-4}},
  url          = {{http://dx.doi.org/10.1016/j.fct.2020.111885}},
  doi          = {{10.1016/j.fct.2020.111885}},
  volume       = {{149}},
  year         = {{2021}},
}

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RIFM fragrance ingredient safety assessment, 3,4,4a,5,8,8a(Or 3,4,4a,7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran, CAS Registry Number 72429-08-4