RIFM fragrance ingredient safety assessment, isobutyric acid, CAS Registry Number 79-31-2

被引:0
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作者
Api, A. M. [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 ]
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, Expert Panel, Med Ctr, 161 Ft Washington Ave, New York, NY 10032 USA
[3] Malmo Univ Hosp, Dept Occupat & Environm Dermatol, Expert Panel, Sodra Forstadsgatan 101,Entrance 47, SE-20502 Malmo, Sweden
[4] Univ Michigan, Sch Nat Resources & Environm, Expert Panel, Dana Bldg G110,440 Church St, Ann Arbor, MI 58109 USA
[5] Fraunhofer Inst Toxicol & Expt Med, Expert Panel, Nikolai Fuchs Str 1, D-30625 Hannover, Germany
[6] Univ Sao Paulo, Sch Vet Med & Anim Sci, Dept Pathol, Expert Panel, Av Prof Dr Orlando Marques de Paiva 87, BR-05508900 Sao Paulo, Brazil
[7] Univ Wurzburg, Dept Toxicol, Expert Panel, Versbacher Str 9, D-97078 Wurzburg, Germany
[8] Oregon Hlth & Sci Univ, Expert Panel, 3181 Sw Sam Jackson Pk Rd, Portland, OR 97239 USA
[9] Vanderbilt Univ, Ctr Mol Toxicol, Dept Biochem, 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, 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, Expert Panel, 2407 River Dr, Knoxville, TN 37996 USA
[12] Univ Arizona, Coll Med, Dept Pharmacol, Expert Panel, 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
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.2020.111673
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. Isobutyric acid was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that isobutyric acid is not genotoxic. Data on read-across analog propionic acid (CAS # 79-09-4) provide a calculated MOE >100 for the repeated dose toxicity and fertility endpoints. Data on read-across analog isovaleric acid (CAS # 503-74-2) provide a calculated MOE >100 for the developmental toxicity endpoint. The skin sensitization endpoint was completed using the DST for non-reactive materials (900 [mu g/cm(2)); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; isobutyric acid is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the TIC for a Cramer Class I material, and the exposure to isobutyric acid is below the TIC (1.4 mg/day). The environmental endpoints were evaluated; isobutyric acid 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:9
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