RIFM fragrance ingredient safety assessment, 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole, CAS Registry Number 38303-23-0
(2021) In Food and Chemical Toxicology 149.- Abstract
The existing information supports the use of this material as described in this safety assessment. 4,5,6,7,8,9,10,11,12,13-Decahydrocyclododecaoxazole was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole 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 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day,... (More)
The existing information supports the use of this material as described in this safety assessment. 4,5,6,7,8,9,10,11,12,13-Decahydrocyclododecaoxazole was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole 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 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole 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; 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole 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
- 2021-01-16
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- And reproductive toxicity, Developmental, Environmental safety, Genotoxicity, Local respiratory toxicity, Phototoxicity/photoallergenicity, Repeated dose, Skin sensitization
- in
- Food and Chemical Toxicology
- volume
- 149
- article number
- 111983
- publisher
- Elsevier
- external identifiers
-
- scopus:85100061202
- pmid:33460695
- ISSN
- 0278-6915
- DOI
- 10.1016/j.fct.2021.111983
- language
- English
- LU publication?
- no
- id
- 364e900b-0f99-4b56-b058-eac9b318ce6d
- date added to LUP
- 2021-02-10 09:05:12
- date last changed
- 2024-05-30 06:29:16
@article{364e900b-0f99-4b56-b058-eac9b318ce6d,
abstract = {{<p>The existing information supports the use of this material as described in this safety assessment. 4,5,6,7,8,9,10,11,12,13-Decahydrocyclododecaoxazole was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole 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 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole 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; 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole 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 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 = {{And reproductive toxicity; Developmental; Environmental safety; Genotoxicity; Local respiratory toxicity; Phototoxicity/photoallergenicity; Repeated dose; Skin sensitization}},
language = {{eng}},
month = {{01}},
publisher = {{Elsevier}},
series = {{Food and Chemical Toxicology}},
title = {{RIFM fragrance ingredient safety assessment, 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole, CAS Registry Number 38303-23-0}},
url = {{http://dx.doi.org/10.1016/j.fct.2021.111983}},
doi = {{10.1016/j.fct.2021.111983}},
volume = {{149}},
year = {{2021}},
}