RIFM fragrance ingredient safety assessment, β-sinensal, CAS Registry Number 60066-88-8

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, Dept Dermatol, Fragrance Safety, Med Ctr, 161 Ft Washington Ave, New York, NY 10032 USA
[3] Malmo Univ Hosp, Dept Occupat & Environm Dermatol, Fragrance Safety, Sodra Forstadsgatan 101,Entrance 47, SE-20502 Malmo, Sweden
[4] Univ Michigan, Sch Nat Resources & Environm, Fragrance Safety, Dana Bldg G110,440 Church St, Ann Arbor, MI 48109 USA
[5] Univ Sao Paulo, Sch Vet Med & Anim Sci, Dept Pathol, Fragrance Safety, Av Prof Dr Orlando Marques de Paiva 87, BR-05508900 Sao Paulo, Brazil
[6] Univ Wurzburg, Dept Toxicol, Fragrance Safety, Versbacher Str 9, D-97078 Wurzburg, Germany
[7] Oregon Hlth & Sci Univ, Fragrance Safety, 3181 SW Sam Jackson Pk Rd, Portland, OR 97239 USA
[8] Vanderbilt Univ, Ctr Mol Toxicol, Dept Biochem, Sch Med,Fragrance Safety, 638 Robinson Res Bldg,2200 Pierce Ave, Nashville, TN 37232 USA
[9] Univ Penn, Ctr Excellence Environm Toxicol, Perelman Sch Med, Fragrance Safety, 1316 Biomed Res Bldg BRB 2-3,421 Curie Blvd, Philadelphia, PA 19104 USA
[10] Univ Tennessee, Coll Vet Med, Dept Comparat Med, Fragrance Safety, 2407 River Dr, Knoxville, TN 37996 USA
[11] Univ Arizona, Coll Med, Dept Pharmacol, Fragrance Safety, 1501 North Campbell Ave,POB 245050, Tucson, AZ 85724 USA
[12] Hamamatsu Univ Sch Med, Dept Dermatol, Higashi Ku, Journal Dermatol Sci JDS,Fragrance Safety, 1-20-1 Handayama, Hamamatsu, Shizuoka 4313192, Japan
关键词
DERMAL SENSITIZATION THRESHOLD; PERSONAL CARE; DST APPROACH; CONSUMER EXPOSURE; MODEL; ABSORPTION; COSMETICS; CHEMICALS; DATASET; TTC;
D O I
10.1016/j.fct.2022.113223
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. beta-Sinensal was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analogs 3,7-dimethyl-2-methylenocta-6-enal (CAS # 22418-66-2) and beta-farnesene (CAS # 18794-84-8) show that beta-sinensal 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 beta-sinensal is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The skin sensitization endpoint was completed using the Dermal Sensitization Threshold (DST) for reactive materials (64 mu g/cm(2)); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra from read-across material farnesal (CAS # 19317-11-4); beta-sinensal is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; beta-sinensal 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:9
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