RIFM fragrance ingredient safety assessment, 3-octanol, CAS Registry Number 589-98-0

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.2020.111868

RIFM fragrance ingredient safety assessment, 3-octanol, CAS Registry Number 589-98-0

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

1 Scopus citations

Abstract

Summary: The existing information supports the use of this material as described in this safety assessment. 3-Octanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 3-hexanol (CAS # 623-37-0) show that 3-octanol is not expected to be genotoxic. Data on 3-octanol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog 2-octanol (CAS # 123-96-6) provide a calculated MOE >100 for the reproductive toxicity endpoint and show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3-octanol is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 3-octanol 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	111868
Journal	Food and Chemical Toxicology
Volume	149
DOIs	https://doi.org/10.1016/j.fct.2020.111868
State	Published - Mar 2021

Keywords

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

ASJC Scopus subject areas

Food Science
Toxicology

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10.1016/j.fct.2020.111868

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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, 3-octanol, CAS Registry Number 589-98-0. Food and Chemical Toxicology, 149, Article 111868. https://doi.org/10.1016/j.fct.2020.111868

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, 3-octanol, CAS Registry Number 589-98-0', Food and Chemical Toxicology, vol. 149, 111868. https://doi.org/10.1016/j.fct.2020.111868

@article{8d18553b37b744c3bf7f433e415631eb,

title = "RIFM fragrance ingredient safety assessment, 3-octanol, CAS Registry Number 589-98-0",

abstract = "Summary: The existing information supports the use of this material as described in this safety assessment. 3-Octanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 3-hexanol (CAS # 623-37-0) show that 3-octanol is not expected to be genotoxic. Data on 3-octanol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog 2-octanol (CAS # 123-96-6) provide a calculated MOE >100 for the reproductive toxicity endpoint and show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3-octanol is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 3-octanol 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, Sensitization, Skin",

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} 2020 Elsevier Ltd",

year = "2021",

month = mar,

doi = "10.1016/j.fct.2020.111868",

language = "English (US)",

volume = "149",

journal = "Food and Chemical Toxicology",

issn = "0278-6915",

publisher = "Elsevier Limited",

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TY - JOUR

T1 - RIFM fragrance ingredient safety assessment, 3-octanol, CAS Registry Number 589-98-0

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 - Summary: The existing information supports the use of this material as described in this safety assessment. 3-Octanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 3-hexanol (CAS # 623-37-0) show that 3-octanol is not expected to be genotoxic. Data on 3-octanol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog 2-octanol (CAS # 123-96-6) provide a calculated MOE >100 for the reproductive toxicity endpoint and show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3-octanol is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 3-octanol 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 - Summary: The existing information supports the use of this material as described in this safety assessment. 3-Octanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 3-hexanol (CAS # 623-37-0) show that 3-octanol is not expected to be genotoxic. Data on 3-octanol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog 2-octanol (CAS # 123-96-6) provide a calculated MOE >100 for the reproductive toxicity endpoint and show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3-octanol is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 3-octanol 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 - Sensitization

KW - Skin

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U2 - 10.1016/j.fct.2020.111868

DO - 10.1016/j.fct.2020.111868

M3 - Short survey

C2 - 33220393

AN - SCOPUS:85097671971

SN - 0278-6915

VL - 149

JO - Food and Chemical Toxicology

JF - Food and Chemical Toxicology

M1 - 111868

ER -

RIFM fragrance ingredient safety assessment, 3-octanol, CAS Registry Number 589-98-0

Abstract

Keywords

ASJC Scopus subject areas

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