RIFM fragrance ingredient safety assessment, cyclododecaneethanol, β-methyl-, CAS Registry Number 118562-73-5

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, Member RIFM Expert Panel, Med Ctr, 161 Ft Washington Ave, New York, NY 10032 USA
[3] Malmo Univ Hosp, Dept Occupat & Environm Dermatol, Member RIFM Expert Panel, Sodra Forstadsgatan 101,Entrance 47, SE-20502 Malmo, Sweden
[4] Univ Michigan, Sch Nat Resources & Environm, Member RIFM Expert Panel, Dana Bldg G110,440 Church St, Ann Arbor, MI 58109 USA
[5] Fraunhofer Inst Toxicol & Expt Med, Member RIFM Expert Panel, Nikolai Fuchs Str 1, D-30625 Hannover, Germany
[6] Univ Sao Paulo, Sch Vet Med & Anim Sci, Dept Pathol, Member RIFM Expert Panel, Av Prof Dr Orlando Marques Paiva 87, BR-05508900 Sao Paulo, Brazil
[7] Univ Wurzburg, Dept Toxicol, Member RIFM Expert Panel, Versbacher Str 9, D-97078 Wurzburg, Germany
[8] Oregon Hlth & Sci Univ, Member RIFM Expert Panel, 3181 SW Sam Jackson Pk Rd, Portland, OR 97239 USA
[9] Vanderbilt Univ, Ctr Mol Toxicol, Dept Biochem, Sch Med,Member RIFM Expert Panel, 638 Robinson Res Bldg,2200 Pierce Ave, Nashville, TN 37232 USA
[10] Univ Penn, Ctr Excellence Environm Toxicol, Perelman Sch Med, Member 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, Member RIFM Expert Panel, 2407 River Dr, Knoxville, TN 37996 USA
[12] Univ Arizona, Coll Med, Dept Pharmacol, Member RIFM Expert Panel, 1501 North Campbell Ave,POB 245050, Tucson, AZ 85724 USA
[13] Hamamatsu Univ, Dept Dermatol, Journal Dermatol Sci JDS, Member RIFM Expert Panel,Sch Med,Higashi Ku, 1-20-1 Handayama, Hamamatsu, Shizuoka 4313192, Japan
关键词
Genotoxicity; Repeated dose; Developmental; Reproductive toxicity; Skin sensitization; Phototoxicity/Photoallergenicity; Local respiratory toxicity; Environmental safety; PERSONAL CARE; CONSUMER EXPOSURE; MODEL; ABSORPTION; COSMETICS; THRESHOLD;
D O I
10.1016/j.fct.2020.111485
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. Cyclododecaneethanol, beta-methyl- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog tricyclo[3.3.1.1.(3.7)]decan-2-ol, 4-methyl-8-methylene- (CAS # 122760-84-3) show that cyclododecaneethanol, beta-methyl- is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to cyclododecaneethanol, beta-methyl- is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data from cyclododecaneethanol, n-methyl- show that there are no safety concerns for cyclododecaneethanol, beta-methyl-for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; cyclododecaneethanol, beta-methyl- is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; cyclododecaneethanol, beta-methyl- 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 in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are < 1.
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页数:7
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