RIFM fragrance ingredient safety assessment, 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol, CAS registry number 63500-71-0

A. M. Api; D. Belsito; D. Botelho; M. Bruze; G. A. Burton; J. Buschmann; M. L. Dagli; M. Date; W. Dekant; C. Deodhar; M. Francis; A. D. Fryer; L. Jones; K. Joshi; S. La Cava; A. Lapczynski; D. C. Liebler; D. O'Brien; A. Patel; T. M. Penning; G. Ritacco; J. Romine; N. Sadekar; D. Salvito; T. W. Schultz; I. G. Sipes; G. Sullivan; Y. Thakkar; Y. Tokura; S. Tsang

doi:10.1016/j.fct.2019.110564

RIFM fragrance ingredient safety assessment, 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol, CAS registry number 63500-71-0

A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, M. Francis, A. D. Fryer, L. Jones, K. Joshi, S. La Cava, A. Lapczynski, D. C. Liebler, D. O'Brien, A. Patel, T. M. PenningG. Ritacco, J. Romine, N. Sadekar, D. Salvito, T. W. Schultz, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura, S. Tsang

Pulmonary and Critical Care Medicine

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

1 Scopus citations

Abstract

2-Isobutyl-4-methyltetrahydro-2H-pyran-4-ol) was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol is not genotoxic, does not have skin sensitization potential, and provided an MOE >100 for the repeated dose, developmental, and reproductive toxicity endpoints. The local respiratory toxicity endpoint was completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class III material (0.47 mg/day). The phototoxicity/photoallergenicity endpoint was completed based on UV spectra and data on 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol. The environmental endpoints were evaluated; 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

Original language	English (US)
Article number	110564
Journal	Food and Chemical Toxicology
Volume	130
DOIs	https://doi.org/10.1016/j.fct.2019.110564
State	Published - Aug 2019

ASJC Scopus subject areas

Food Science
Toxicology

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10.1016/j.fct.2019.110564

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Api, A. M., Belsito, D., Botelho, D., Bruze, M., Burton, G. A., Buschmann, J., Dagli, M. L., Date, M., Dekant, W., Deodhar, C., Francis, M., Fryer, A. D., Jones, L., Joshi, K., La Cava, S., Lapczynski, A., Liebler, D. C., O'Brien, D., Patel, A., ... Tsang, S. (2019). RIFM fragrance ingredient safety assessment, 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol, CAS registry number 63500-71-0. Food and Chemical Toxicology, 130, Article 110564. https://doi.org/10.1016/j.fct.2019.110564

Api, AM, Belsito, D, Botelho, D, Bruze, M, Burton, GA, Buschmann, J, Dagli, ML, Date, M, Dekant, W, Deodhar, C, Francis, M, Fryer, AD, Jones, L, Joshi, K, La Cava, S, Lapczynski, A, Liebler, DC, O'Brien, D, Patel, A, Penning, TM, Ritacco, G, Romine, J, Sadekar, N, Salvito, D, Schultz, TW, Sipes, IG, Sullivan, G, Thakkar, Y, Tokura, Y & Tsang, S 2019, 'RIFM fragrance ingredient safety assessment, 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol, CAS registry number 63500-71-0', Food and Chemical Toxicology, vol. 130, 110564. https://doi.org/10.1016/j.fct.2019.110564

@article{c917867410b24e809087880fe8b2ee3c,

title = "RIFM fragrance ingredient safety assessment, 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol, CAS registry number 63500-71-0",

abstract = "2-Isobutyl-4-methyltetrahydro-2H-pyran-4-ol) was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol is not genotoxic, does not have skin sensitization potential, and provided an MOE >100 for the repeated dose, developmental, and reproductive toxicity endpoints. The local respiratory toxicity endpoint was completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class III material (0.47 mg/day). The phototoxicity/photoallergenicity endpoint was completed based on UV spectra and data on 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol. The environmental endpoints were evaluated; 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., 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 Dagli, {M. L.} and M. Date and W. Dekant and C. Deodhar and M. Francis and Fryer, {A. D.} and L. Jones and K. Joshi and {La Cava}, S. and A. Lapczynski and Liebler, {D. C.} and D. O'Brien and A. Patel and Penning, {T. M.} and G. Ritacco and J. Romine and N. Sadekar and D. Salvito and Schultz, {T. W.} and Sipes, {I. G.} and G. Sullivan and Y. Thakkar and Y. Tokura and S. Tsang",

note = "Publisher Copyright: {\textcopyright} 2019 Elsevier Ltd",

year = "2019",

month = aug,

doi = "10.1016/j.fct.2019.110564",

language = "English (US)",

volume = "130",

journal = "Food and Chemical Toxicology",

issn = "0278-6915",

publisher = "Elsevier Limited",

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TY - JOUR

T1 - RIFM fragrance ingredient safety assessment, 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol, CAS registry number 63500-71-0

AU - Api, A. M.

AU - Belsito, D.

AU - Botelho, D.

AU - Bruze, M.

AU - Burton, G. A.

AU - Buschmann, J.

AU - Dagli, M. L.

AU - Date, M.

AU - Dekant, W.

AU - Deodhar, C.

AU - Francis, M.

AU - Fryer, A. D.

AU - Jones, L.

AU - Joshi, K.

AU - La Cava, S.

AU - Lapczynski, A.

AU - Liebler, D. C.

AU - O'Brien, D.

AU - Patel, A.

AU - Penning, T. M.

AU - Ritacco, G.

AU - Romine, J.

AU - Sadekar, N.

AU - Salvito, D.

AU - Schultz, T. W.

AU - Sipes, I. G.

AU - Sullivan, G.

AU - Thakkar, Y.

AU - Tokura, Y.

AU - Tsang, S.

PY - 2019/8

Y1 - 2019/8

N2 - 2-Isobutyl-4-methyltetrahydro-2H-pyran-4-ol) was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol is not genotoxic, does not have skin sensitization potential, and provided an MOE >100 for the repeated dose, developmental, and reproductive toxicity endpoints. The local respiratory toxicity endpoint was completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class III material (0.47 mg/day). The phototoxicity/photoallergenicity endpoint was completed based on UV spectra and data on 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol. The environmental endpoints were evaluated; 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

AB - 2-Isobutyl-4-methyltetrahydro-2H-pyran-4-ol) was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol is not genotoxic, does not have skin sensitization potential, and provided an MOE >100 for the repeated dose, developmental, and reproductive toxicity endpoints. The local respiratory toxicity endpoint was completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class III material (0.47 mg/day). The phototoxicity/photoallergenicity endpoint was completed based on UV spectra and data on 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol. The environmental endpoints were evaluated; 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

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U2 - 10.1016/j.fct.2019.110564

DO - 10.1016/j.fct.2019.110564

M3 - Short survey

C2 - 31199993

AN - SCOPUS:85067656883

SN - 0278-6915

VL - 130

JO - Food and Chemical Toxicology

JF - Food and Chemical Toxicology

M1 - 110564

ER -

RIFM fragrance ingredient safety assessment, 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol, CAS registry number 63500-71-0

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