RIFM fragrance ingredient safety assessment, γ-methyldecalactone, CAS Registry Number 7011-83-8

被引：0

作者：

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

Belmonte, F. ^{[2
]}

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, Med Ctr, 161 Ft Washington Ave, New York, NY 10032 USA

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

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

[5] Fraunhofer Inst Toxicol & Expt Med, Nilcolai Fuchs Str 1, D-30625 Hannover, Germany

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

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

[8] Oregon Hlth & Sci Univ, 3181 Sw Sam Jackson Pk Rd, Portland, OR 97239 USA

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

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

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

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

[13] Hamamatsu Univ, Dept Dermatol, Sch Med, Higashi Ku, 1-20-1 Handayama, Hamamatsu, Shizuoka 4313192, Japan

来源：

FOOD AND CHEMICAL TOXICOLOGY | 2020年 / 141卷

关键词：

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

D O I：

10.1016/j.fct.2020.111336

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. gamma-Methyldecalactone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from the target material and read-across analog ( +/- ) 3-methyl-y-decalactone (CAS # 67663-01-8) show that gamma-methyldecalactone is not expected to be genotoxic. Data on read-across analogs ( +/- ) 3-methyl-gamma-decalactone (CAS # 67663-01-8) and gamma-hexalactone (gamma-caprolactone; CAS # 695-06-7) provide a calculated MOE > 100 for the repeated dose and developmental toxicity endpoints, respectively. The fertility and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class I material, and the exposure to gamma-methyldecalactone is below the ITC (0.03 mg/kg/day and 1.4 mg/day, respectively). Data show that there are no safety concerns for gamma-methyldecalactone for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and UV spectra; gamma-methyldecalactone is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; gamma-methyldecalactone 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

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Lavelle, M.
Lee, I.
Moustakas, H.
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Schember, I.
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