RIFM fragrance ingredient safety assessment, 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal, CAS Registry Number 65405-84-7

A. M. Api; D. Belsito; D. Botelho; M. Bruze; G. A. Burton; J. Buschmann; M. A. Cancellieri; M. L. Dagli; M. Date; W. Dekant; C. Deodhar; A. D. Fryer; 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.2022.112865

RIFM fragrance ingredient safety assessment, 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal, CAS Registry Number 65405-84-7

A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. A. Cancellieri, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I. Lee, D. C. Liebler, H. MoustakasM. 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. 4-(2,6,6-Trimethyl-2-cyclohexen)-2-methylbutanal was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal 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 I material, and the exposure to 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data provided 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm² for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal 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	112865
Journal	Food and Chemical Toxicology
Volume	161
DOIs	https://doi.org/10.1016/j.fct.2022.112865
State	Published - Mar 2022

ASJC Scopus subject areas

Food Science
Toxicology

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10.1016/j.fct.2022.112865

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Api, A. M., Belsito, D., Botelho, D., Bruze, M., Burton, G. A., Buschmann, J., Cancellieri, M. A., Dagli, M. L., Date, M., Dekant, W., Deodhar, C., Fryer, A. D., Jones, L., Joshi, K., Kumar, M., Lapczynski, A., Lavelle, M., Lee, I., Liebler, D. C., ... Tokura, Y. (2022). RIFM fragrance ingredient safety assessment, 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal, CAS Registry Number 65405-84-7. Food and Chemical Toxicology, 161, Article 112865. https://doi.org/10.1016/j.fct.2022.112865

Api, AM, Belsito, D, Botelho, D, Bruze, M, Burton, GA, Buschmann, J, Cancellieri, MA, Dagli, ML, Date, M, Dekant, W, Deodhar, C, Fryer, AD, 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 2022, 'RIFM fragrance ingredient safety assessment, 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal, CAS Registry Number 65405-84-7', Food and Chemical Toxicology, vol. 161, 112865. https://doi.org/10.1016/j.fct.2022.112865

@article{f96b4f087c454e9cb92fde968cc1f3e5,

title = "RIFM fragrance ingredient safety assessment, 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal, CAS Registry Number 65405-84-7",

abstract = "The existing information supports the use of this material as described in this safety assessment. 4-(2,6,6-Trimethyl-2-cyclohexen)-2-methylbutanal was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal 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 I material, and the exposure to 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data provided 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm2 for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal 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.",

author = "Api, {A. M.} and D. Belsito 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 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} 2022 Elsevier Ltd",

year = "2022",

month = mar,

doi = "10.1016/j.fct.2022.112865",

language = "English (US)",

volume = "161",

journal = "Food and Chemical Toxicology",

issn = "0278-6915",

publisher = "Elsevier Limited",

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TY - JOUR

T1 - RIFM fragrance ingredient safety assessment, 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal, CAS Registry Number 65405-84-7

AU - Api, A. M.

AU - Belsito, D.

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 - 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 - 2022/3

Y1 - 2022/3

N2 - The existing information supports the use of this material as described in this safety assessment. 4-(2,6,6-Trimethyl-2-cyclohexen)-2-methylbutanal was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal 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 I material, and the exposure to 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data provided 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm2 for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal 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. 4-(2,6,6-Trimethyl-2-cyclohexen)-2-methylbutanal was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal 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 I material, and the exposure to 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data provided 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm2 for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal 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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UR - http://www.scopus.com/inward/citedby.url?scp=85124885936&partnerID=8YFLogxK

U2 - 10.1016/j.fct.2022.112865

DO - 10.1016/j.fct.2022.112865

M3 - Short survey

C2 - 35176436

AN - SCOPUS:85124885936

SN - 0278-6915

VL - 161

JO - Food and Chemical Toxicology

JF - Food and Chemical Toxicology

M1 - 112865

ER -

RIFM fragrance ingredient safety assessment, 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal, CAS Registry Number 65405-84-7

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