RIFM fragrance ingredient safety assessment, 7,9-dimethylspiro[5.5]undecan-3-one, CAS Registry Number 83863-64-3

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

doi:10.1016/j.fct.2021.111993

RIFM fragrance ingredient safety assessment, 7,9-dimethylspiro[5.5]undecan-3-one, CAS Registry Number 83863-64-3

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

Pulmonary and Critical Care Medicine

Research output: Contribution to journal › Short survey › peer-review

Abstract

The existing information supports the use of this material as described in this safety assessment. 7,9-Dimethylspiro[5.5]undecan-3-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 7,9-dimethylspiro[5.5]undecan-3-one 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 II material, and the exposure to 7,9-dimethylspiro[5.5]undecan-3-one is below the TTC (0.009 mg/kg/day, 0.009 mg/kg/day, and 0.47 mg/day, respectively). Based on the existing data and readacross material spiro[5.5]undec-8-en-1-one, 2,2,7,9-tetramethyl- (CAS # 502847-01-0), 7,9-dimethylspiro[5.5]undecan-3-one presents no concern for skin sensitization under the current, declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet (UV) spectra; 7,9-dimethylspiro[5.5]undecan-3-one is not phototoxic/photoallergenic. The environmental endpoints were evaluated; 7,9-dimethylspiro[5.5]undecan-3-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.

Original language	English (US)
Article number	111993
Journal	Food and Chemical Toxicology
Volume	149
DOIs	https://doi.org/10.1016/j.fct.2021.111993
State	Published - Mar 2021

Keywords

And reproductive toxicity
Developmental
Environmental safety
Genotoxicity
Local respiratory toxicity
Phototoxicity/photoallergenicity
Repeated dose
Skin sensitization

ASJC Scopus subject areas

Food Science
Toxicology

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10.1016/j.fct.2021.111993

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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., ... Tokura, Y. (2021). RIFM fragrance ingredient safety assessment, 7,9-dimethylspiro[5.5]undecan-3-one, CAS Registry Number 83863-64-3. Food and Chemical Toxicology, 149, Article 111993. https://doi.org/10.1016/j.fct.2021.111993

Api, AM, Belsito, D, Biserta, S, Botelho, D, Bruze, M, Burton, GA, Buschmann, J, Cancellieri, MA, Dagli, ML, Date, M, Dekant, W, Deodhar, C, Fryer, AD, Gadhia, S, Jones, L, Joshi, K, Kumar, M, Lapczynski, A, Lavelle, M, Lee, I, Liebler, DC, Moustakas, H, Na, M, Penning, TM, Ritacco, G, Romine, J, Sadekar, N, Schultz, TW, Selechnik, D, Siddiqi, F, Sipes, IG, Sullivan, G, Thakkar, Y & Tokura, Y 2021, 'RIFM fragrance ingredient safety assessment, 7,9-dimethylspiro[5.5]undecan-3-one, CAS Registry Number 83863-64-3', Food and Chemical Toxicology, vol. 149, 111993. https://doi.org/10.1016/j.fct.2021.111993

@article{e75a17c4f3254247a349c251895f6a35,

title = "RIFM fragrance ingredient safety assessment, 7,9-dimethylspiro[5.5]undecan-3-one, CAS Registry Number 83863-64-3",

abstract = "The existing information supports the use of this material as described in this safety assessment. 7,9-Dimethylspiro[5.5]undecan-3-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 7,9-dimethylspiro[5.5]undecan-3-one 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 II material, and the exposure to 7,9-dimethylspiro[5.5]undecan-3-one is below the TTC (0.009 mg/kg/day, 0.009 mg/kg/day, and 0.47 mg/day, respectively). Based on the existing data and readacross material spiro[5.5]undec-8-en-1-one, 2,2,7,9-tetramethyl- (CAS # 502847-01-0), 7,9-dimethylspiro[5.5]undecan-3-one presents no concern for skin sensitization under the current, declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet (UV) spectra; 7,9-dimethylspiro[5.5]undecan-3-one is not phototoxic/photoallergenic. The environmental endpoints were evaluated; 7,9-dimethylspiro[5.5]undecan-3-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.",

keywords = "And reproductive toxicity, Developmental, Environmental safety, Genotoxicity, Local respiratory toxicity, Phototoxicity/photoallergenicity, Repeated dose, Skin sensitization",

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

note = "Publisher Copyright: {\textcopyright} 2021 Elsevier Ltd",

year = "2021",

month = mar,

doi = "10.1016/j.fct.2021.111993",

language = "English (US)",

volume = "149",

journal = "Food and Chemical Toxicology",

issn = "0278-6915",

publisher = "Elsevier Limited",

}

TY - JOUR

T1 - RIFM fragrance ingredient safety assessment, 7,9-dimethylspiro[5.5]undecan-3-one, CAS Registry Number 83863-64-3

AU - Api, A. M.

AU - Belsito, D.

AU - Biserta, S.

AU - Botelho, D.

AU - Bruze, M.

AU - Burton, G. A.

AU - Buschmann, J.

AU - Cancellieri, M. A.

AU - Dagli, M. L.

AU - Date, M.

AU - Dekant, W.

AU - Deodhar, C.

AU - Fryer, A. D.

AU - Gadhia, S.

AU - Jones, L.

AU - Joshi, K.

AU - Kumar, M.

AU - Lapczynski, A.

AU - Lavelle, M.

AU - Lee, I.

AU - Liebler, D. C.

AU - Moustakas, H.

AU - Na, M.

AU - Penning, T. M.

AU - Ritacco, G.

AU - Romine, J.

AU - Sadekar, N.

AU - Schultz, T. W.

AU - Selechnik, D.

AU - Siddiqi, F.

AU - Sipes, I. G.

AU - Sullivan, G.

AU - Thakkar, Y.

AU - Tokura, Y.

PY - 2021/3

Y1 - 2021/3

N2 - The existing information supports the use of this material as described in this safety assessment. 7,9-Dimethylspiro[5.5]undecan-3-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 7,9-dimethylspiro[5.5]undecan-3-one 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 II material, and the exposure to 7,9-dimethylspiro[5.5]undecan-3-one is below the TTC (0.009 mg/kg/day, 0.009 mg/kg/day, and 0.47 mg/day, respectively). Based on the existing data and readacross material spiro[5.5]undec-8-en-1-one, 2,2,7,9-tetramethyl- (CAS # 502847-01-0), 7,9-dimethylspiro[5.5]undecan-3-one presents no concern for skin sensitization under the current, declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet (UV) spectra; 7,9-dimethylspiro[5.5]undecan-3-one is not phototoxic/photoallergenic. The environmental endpoints were evaluated; 7,9-dimethylspiro[5.5]undecan-3-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.

AB - The existing information supports the use of this material as described in this safety assessment. 7,9-Dimethylspiro[5.5]undecan-3-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 7,9-dimethylspiro[5.5]undecan-3-one 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 II material, and the exposure to 7,9-dimethylspiro[5.5]undecan-3-one is below the TTC (0.009 mg/kg/day, 0.009 mg/kg/day, and 0.47 mg/day, respectively). Based on the existing data and readacross material spiro[5.5]undec-8-en-1-one, 2,2,7,9-tetramethyl- (CAS # 502847-01-0), 7,9-dimethylspiro[5.5]undecan-3-one presents no concern for skin sensitization under the current, declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet (UV) spectra; 7,9-dimethylspiro[5.5]undecan-3-one is not phototoxic/photoallergenic. The environmental endpoints were evaluated; 7,9-dimethylspiro[5.5]undecan-3-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.

KW - And reproductive toxicity

KW - Developmental

KW - Environmental safety

KW - Genotoxicity

KW - Local respiratory toxicity

KW - Phototoxicity/photoallergenicity

KW - Repeated dose

KW - Skin sensitization

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U2 - 10.1016/j.fct.2021.111993

DO - 10.1016/j.fct.2021.111993

M3 - Short survey

C2 - 33460702

AN - SCOPUS:85100670034

SN - 0278-6915

VL - 149

JO - Food and Chemical Toxicology

JF - Food and Chemical Toxicology

M1 - 111993

ER -

RIFM fragrance ingredient safety assessment, 7,9-dimethylspiro[5.5]undecan-3-one, CAS Registry Number 83863-64-3

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

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