RIFM fragrance ingredient safety assessment, tetrahydro-2-isobutyl-4-methyl-2H-pyrane, CAS Registry Number 13477-62-8

被引：0

作者：

Api, A. M. ^{[1
]}

Belsito, D. ^{[2
]}

Botelho, D. ^{[1
]}

Bruze, M. ^{[3
]}

Burton Jr, G. A. ^{[4
]}

Cancellieri, M. A. ^{[1
]}

Chon, H. ^{[1
]}

Dagli, M. L. ^{[5
]}

Date, M. ^{[1
]}

Dekant, W. ^{[6
]}

Deodhar, C. ^{[1
]}

Fryer, A. D. ^{[7
]}

Jones, L. ^{[1
]}

Joshi, K. ^{[1
]}

Kumar, M. ^{[1
]}

Lapczynski, A. ^{[1
]}

Lavelle, M. ^{[1
]}

Lee, I ^{[1
]}

Liebler, D. C. ^{[8
]}

Moustakas, H. ^{[1
]}

Na, M. ^{[1
]}

Penning, T. M. ^{[9
]}

Ritacco, G. ^{[1
]}

Romine, J. ^{[1
]}

Sadekar, N. ^{[1
]}

Schultz, T. W. ^{[10
]}

Selechnik, D. ^{[1
]}

Siddiqi, F. ^{[1
]}

Sipes, I. G. ^{[11
]}

Sullivan, G. ^{[1
]}

Thakkar, Y. ^{[1
]}

Tokura, Y. ^{[12
]}

机构：

[1] Res Inst Fragrance Mat Inc, 50 Tice Blvd, Woodcliff Lake, NJ 07677 USA

[2] Columbia Univ, Dept Dermatol, Expert Panel Fragrance Safety, Med Ctr, 161 Ft Washington Ave, New York, NY 10032 USA

[3] Malmo Univ Hosp, Dept Occupat & Environm Dermatol, Expert Panel Fragrance Safety, Sodra Forstadsgatan 101,Entrance 47, SE-20502 Malmo, Sweden

[4] Univ Michigan, Sch Nat Resources & Environm, Expert Panel Fragrance Safety, Dana Bldg G110,440 Church St, Ann Arbor, MI 48109 USA

[5] Univ Sao Paulo, Sch Vet Med & Anim Sci, Dept Pathol, Panel Fragrance Safety, Av Prof Dr Orlando Marques De Paiva 87, BR-05508900 Sao Paulo, Brazil

[6] Univ Wurzburg, Dept Toxicol, Expert Panel Fragrance Safety, Versbacher Str 9, D-97078 Wurzburg, Germany

[7] Oregon Hlth & Sci Univ, Expert Panel Fragrance Safety, 3181 Sw Sam Jackson Pk Rd, Portland, OR 97239 USA

[8] Vanderbilt Univ, Ctr Mol Toxicol, Dept Biochem, Expert Panel Fragrance Safety,Sch Med, 638 Robinson Res Bldg,2200 Pierce Ave, Nashville, TN 37232 USA

[9] Univ Penn, Ctr Excellence Environm Toxicol, Perelman Sch Med, Expert Panel Fragrance Safety, 1316 Biomed Res Bldg BRB 2-3,421 Curie Blvd, Philadelphia, PA 19104 USA

[10] Univ Tennessee, Coll Vet Med, Dept Comparat Med, Expert Panel Fragrance Safety, 2407 River Dr, Knoxville, TN 37996 USA

[11] Univ Arizona, Coll Med, Dept Pharmacol, Expert Panel Fragrance Safety, 1501 North Campbell Ave,POB 245050, Tucson, AZ 85724 USA

[12] Hamamatsu Univ, Expert Panel Fragrance Safety, Journal Dermatol Sci JDS, Sch Med,Dept Dermatol,Higashi Ku, 1-20-1 Handayama, Hamamatsu, Shizuoka 4313192, Japan

来源：

FOOD AND CHEMICAL TOXICOLOGY | 2022年 / 167卷

关键词：

PERSONAL CARE; CONSUMER EXPOSURE; COSMETICS; THRESHOLD; MODEL;

D O I：

10.1016/j.fct.2022.113323

中图分类号：

TS2 [食品工业];

学科分类号：

0832 ;

摘要：

The existing information supports the use of this material as described in this safety assessment. Tetrahydro-2-isobutyl-4-methyl-2H-pyrane was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that tetrahydro-2-isobutyl-4-methyl-2H-pyrane is not genotoxic, provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints, and show that there are no safety concerns for tetrahydro-2-isobutyl-4-methyl-2H-pyrane for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; tetrahydro-2-isobutyl-4-methyl-2H-pyrane is not expected to be photoirritating/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class III material, and the exposure to tetrahydro-2-isobutyl-4-methyl-2H-pyrane is below the TTC (0.47 mg/day). The environmental endpoints were evaluated; tetrahydro-2-isobutyl-4-methyl-2H-pyrane 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 (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.

引用

页数：7

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