RIFM fragrance ingredient safety assessment, hexyl 2-methylbutyrate, CAS Registry Number 10032-15-2

被引：0

作者：

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

Belsito, D. ^{[2
]}

Biserta, S. ^{[1
]}

Botelho, D. ^{[1
]}

Bruze, M. ^{[3
]}

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

Buschmann, J. ^{[5
]}

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

Dagli, M. L. ^{[6
]}

Date, M. ^{[1
]}

Dekant, W. ^{[7
]}

Deodhar, C. ^{[1
]}

Fryer, A. D. ^{[8
]}

Gadhia, S. ^{[1
]}

Jones, L. ^{[1
]}

Joshi, K. ^{[1
]}

Lapczynski, A. ^{[1
]}

Lavelle, M. ^{[1
]}

Liebler, D. C. ^{[9
]}

Na, M. ^{[1
]}

O'Brien, D. ^{[1
]}

Patel, A. ^{[1
]}

Penning, T. M. ^{[10
]}

Ritacco, G. ^{[1
]}

Rodriguez-Ropero, F. ^{[1
]}

Romine, J. ^{[1
]}

Sadekar, N. ^{[1
]}

Salvito, D. ^{[1
]}

Schultz, T. W. ^{[11
]}

Siddiqi, F. ^{[1
]}

Sipes, I. G. ^{[12
]}

Sullivan, G. ^{[1
]}

Thakkar, Y. ^{[1
]}

Tokura, Y. ^{[13
]}

Tsang, S. ^{[1
]}

机构：

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

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

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

[4] Univ Michigan, Member Expert Panel, Sch Nat Resources & Environmem, Dana Bldg G110,440 Church St, Ann Arbor, MI 58109 USA

[5] Fraunhofer Inst Toxicol & Expt Med, Member Expert Panel, Nacolai Fuchs Str 1, D-30625 Hannover, Germany

[6] Univ Sao Paulo, Sch Vet Med & Anim Sci, Dept Pathol, Member Expert Panel, Av Prof Dr Orlando Marques Paiva 87, BR-05508900 Sao Paulo, Brazil

[7] Univ Wurzburg, Dept Toxicol, Member Expert Panel, Versbacher Str 9, D-97078 Wurzburg, Germany

[8] Oregon Hlth & Sci Univ, Member Expert Panel, 3181 SW Sam Jackson Pk Rd, Portland, OR 97239 USA

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

[10] Univ Penn, Ctr Excellence Environm Toxicol, Perelman Sch Med, Member Expert Panel, 1316 Biomed Res Bldg BRB II-III,421 Curie Blvd, Philadelphia, PA 19104 USA

[11] Univ Tennessee, Coll Vet Med, Dept Comparat Med, Member Expert Panel, 2407 River Dr, Knoxville, TN 37996 USA

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

[13] Hamamatsu Univ Sch Med, Dept Dermatol, Member Expert Panel, 1-20-1 Handayama, Hamamatsu, Shizuoka 4313192, Japan

来源：

FOOD AND CHEMICAL TOXICOLOGY | 2020年 / 144卷

关键词：

Genotoxicity; Repeated dose; Developmental; and Reproductive toxicity; Skin sensitization; Phototoxicity/photoallergenicity; Local respiratory toxicity; Environmental safety; PERSONAL CARE; CONSUMER EXPOSURE; MODEL; ABSORPTION; COSMETICS; THRESHOLD; ASSAY;

D O I：

10.1016/j.fct.2020.111463

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. Hexyl 2-methylbutyrate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog hexyl isobutyrate (CAS # 2349-07-7) show that hexyl 2-methylbutyrate is not expected to be genotoxic. Data on read-across analog propyl (2S)-2-(1,1-dimethylpropoxy)-propanoate (CAS # 319002-92-1) provide a calculated MOE > 100 for the repeated dose toxicity and reproductive toxicity endpoints. Existing data do not indicate that hexyl 2-methylbutyrate is a sensitizer. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; hexyl 2-methylbutyrate is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the TTC for a Cramer Class I material, and the exposure to hexyl 2-methylbutyrate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; hexyl 2-methylbutyrate 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.

引用

页数：9

共 41 条

[1] [Anonymous], 2015, Estimation Programs Interface SuiteTM for Microsoft Windows
[2] [Anonymous], 2012, GUIDANCE INFORM REQU
[3] Api A M, 2015, Food Chem Toxicol, V82 Suppl, pS1, DOI 10.1016/j.fct.2014.11.014
[4] Arctander S, 1969, PERFUME FLAVOR CHEM, V1-2
[5] Arctander S., 1969, Perfume and Flavor Chemicals (Aroma Chemicals), VII
[6] Exposure based waiving: The application of the toxicological threshold of concern (TTC) to inhalation exposure for aerosol ingredients in consumer products
Carthew, P.
Clapp, C.
Gutsell, S.
[J]. FOOD AND CHEMICAL TOXICOLOGY, 2009, 47 (06) : 1287 - 1295
[7] CAESAR models for developmental toxicity
Cassano, Antonio
Manganaro, Alberto
Martin, Todd
Young, Douglas
Piclin, Nadege
Pintore, Marco
Bigoni, Davide
Benfenati, Emilio
[J]. CHEMISTRY CENTRAL JOURNAL, 2010, 4
[8] Integrating habits and practices data for soaps, cosmetics and air care products into an existing aggregate exposure model
Comiskey, D.
Api, A. M.
Barrett, C.
Ellis, G.
McNamara, C.
O'Mahony, C.
Robison, S. H.
Rose, J.
Safford, B.
Smith, B.
Tozer, S.
[J]. REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2017, 88 : 144 - 156
[9] Novel database for exposure to fragrance ingredients in cosmetics and personal care products
Comiskey, D.
Api, A. M.
Barratt, C.
Daly, E. J.
Ellis, G.
McNamara, C.
O'Mahony, C.
Robison, S. H.
Safford, B.
Smith, B.
Tozer, S.
[J]. REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2015, 72 (03) : 660 - 672
[10] ECHA, 2012, PROP 2S 2 2 METH 2 Y

← 1 2 3 4 5 →