RIFM fragrance ingredient safety assessment, ethyl decanoate, CAS Registry Number 110-38-3

被引:0
作者
Api, A. M. [1 ]
Belsito, D. [2 ]
Botelho, D. [1 ]
Bruze, M. [3 ]
Burton, G. A., Jr. [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, Med Ctr, Dept Dermatol, 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] Univ Sao Paulo, Sch Vet Med & Anim Sci, Dept Pathol, Av Prof dr Orlando Marques de Paiva 87, BR-05508900 Sao Paulo, Brazil
[6] Univ Wurzburg, Dept Toxicol, Versbacher Str 9, D-97078 Wurzburg, Germany
[7] Oregon Hlth & Sci Univ, 3181 SW Sam Jackson Pk Rd, Portland, OR 97239 USA
[8] Vanderbilt Univ, Ctr Mol Toxicol, Sch Med, Dept Biochem, 638 Robinson Res Bldg,2200 Pierce Ave, Nashville, TN 37232 USA
[9] Univ Penn, Ctr Excellence Environm Toxicol, Perelman Sch Med, 1316 Biomed Res Bldg BRB 2-3,421 Curie Blvd, Philadelphia, PA 19104 USA
[10] Univ Tennessee, Coll Vet Med, Dept Comparat Med, 2407 River Dr, Knoxville, TN 37996 USA
[11] Univ Arizona, Coll Med, Dept Pharmacol, 1501 North Campbell Ave,POB 245050, Tucson, AZ 85724 USA
[12] Hamamatsu Univ Sch Med, Dept Dermatol, Higashi Ku, 1-20-1 Handayama, Hamamatsu, Shizuoka 4313192, Japan
关键词
CONSUMER EXPOSURE; PERSONAL CARE; MODEL; ABSORPTION; THRESHOLD;
D O I
10.1016/j.fct.2022.113319
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. Ethyl decanoate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that ethyl decanoate is not genotoxic. Data on read-across analog ethyl hexanoate (CAS # 123-66-0) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose and reproductive toxicity endpoints. Data from ethyl decanoate and read-across analog methyl hexadecanoate (CM # 112-39-0) provided ethyl decanoate a No Expected Sensitization Induction Level (NESIL) of 2400 mu g/cm(2) for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; ethyl decanoate is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the threshold of toxicological concern (TTC) for a Cramer Class I material; the exposure to ethyl decanoate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; ethyl decanoate 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.
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页数:9
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