RIFM fragrance ingredient safety assessment, methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate, CAS Registry Number 28043-10-9

被引:0
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作者
Api, A. M. [1 ]
Belmonte, F. [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 ]
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, RIFM Expert Panel, Med Ctr, 161 Ft Washington Ave, New York, NY 10032 USA
[3] Malmo Univ Hosp, Dept Occupat & Environm Dermatol, RIFM Expert Panel, Sodra Forstadsgatan 101,Entrance 47, SE-20502 Malmo, Sweden
[4] Univ Michigan, Sch Nat Resources & Environm, RIFM Expert Panel, Dana Bldg G110,440 Church St, Ann Arbor, MI 58109 USA
[5] Fraunhofer Inst Toxicol & Expt Med, RIFM Expert Panel, Nikolai Fuchs Str 1, D-30625 Hannover, Germany
[6] Univ Sao Paulo, Sch Vet Med & Anim Sci, Dept Pathol, RIFM Expert Panel, Av Prof Dr Orlando Marques de Paiva 87, BR-05508900 Sao Paulo, SP, Brazil
[7] Univ Wurzburg, Dept Toxicol, RIFM Expert Panel, Versbacher Str 9, D-97078 Wurzburg, Germany
[8] Oregon Hlth & Sci Univ, RIFM Expert Panel, 3181 SW Sam Jackson Pk Rd, Portland, OR 97239 USA
[9] Vanderbilt Univ, Ctr Mol Toxicol, Dept Biochem, RIFM 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, RIFM Expert Panel, 1316 Biomed Res Bldg BRB 2-3,421 Curie Blvd, Philadelphia, PA 19104 USA
[11] Univ Tennessee, Coll Vet Med, Dept Comparat Med, RIFM Expert Panel, 2407 River Dr, Knoxville, TN 37996 USA
[12] Univ Arizona, Coll Med, Dept Pharmacol, RIFM Expert Panel, 1501 North Campbell Ave,POB 245050, Tucson, AZ 85724 USA
[13] Hamamatsu Univ Sch Med, Dept Dermatol, Higashi Ku, 1-20-1 Handayama, Hamamatsu, Shizuoka 4313192, Japan
关键词
PERSONAL CARE; CONSUMER EXPOSURE; MODEL; ABSORPTION; COSMETICS; THRESHOLD;
D O I
10.1016/j.fct.2020.111471
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. Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate and read-across analog ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate (CAS # 77851-07-1) show that methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class I material, and the exposure to methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data from read-across analog 3-cyclohexene-1-carboxylic acid, 2,6,6-trimethyl-, methyl ester, (1R,2S)-rel- (CAS # 540734-22-3) show that there are no safety concerns for methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and UV spectra; methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate 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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页数:8
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