RIFM fragrance ingredient safety assessment, dodecyldimethylamine oxide, CAS Registry Number 1643-20-5

被引：2

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
]}

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, Med Ctr, 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] Fraunhofer Inst Toxicol & Expt Med, Nikolai Fuchs Str 1, D-30625 Hannover, Germany

[6] Univ Sao Paulo, Sch Vet Med & Anim Sci, Dept Pathol, Av Prof Dr Orlando Marques de Paiva 87, BR-05508900 Sao Paulo, Brazil

[7] Univ Wurzburg, Dept Toxicol, Versbacher Str 9, D-97078 Wurzburg, Germany

[8] Oregon Hlth & Sci Univ, 3181 SW Sam Jackson Pk Rd, Portland, OR 97239 USA

[9] Vanderbilt Univ, Ctr Mol Toxicol, Dept Biochem, Sch Med, 638 Robinson Res Bldg,2200 Pierce Ave, Nashville, TN 37232 USA

[10] Univ Penn, Ctr Excellence Environm Toxicol, Perelman Sch Med, 1316 Biomed Res Bldg BRB 2-3,421 Curie Blvd, Philadelphia, PA 19104 USA

[11] Univ Tennessee, Coll Vet Med, Dept Comparat Med, 2407 River Dr, Knoxville, TN 37996 USA

[12] Univ Arizona, Coll Med, Dept Pharmacol, 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

来源：

FOOD AND CHEMICAL TOXICOLOGY | 2020年 / 141卷

关键词：

Genotoxicity; Repeated dose; Developmental; Reproductive; Toxicity; Skin sensitization; Phototoxicity/Photoallergenicity; Local respiratory toxicity; Environmental safety; DERMAL SENSITIZATION THRESHOLD; PERSONAL CARE; DST APPROACH; CONSUMER EXPOSURE; COSMETICS; CHEMICALS; DATASET; MODEL;

D O I：

10.1016/j.fct.2020.111424

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. Dodecyldimethylamine oxide was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that dodecyldimethylamine oxide is not genotoxic. Data on dodecyldimethylamine oxide provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints. The skin sensitization endpoint was completed using data and 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 (UV) spectra; dodecyldimethylamine oxide 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 III material, and the exposure to dodecyldimethylamine oxide is below the TTC (0.47 mg/day). The environmental endpoints were evaluated; dodecyldimethylamine oxide 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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