RIFM fragrance ingredient safety assessment, ω-pentadecalactone, CAS Registry Number 106-02-5

被引：2

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
]}

Kumar, M. ^{[1
]}

Lapczynski, A. ^{[1
]}

Lavelle, M. ^{[1
]}

Lee, I ^{[1
]}

Liebler, D. C. ^{[9
]}

Moustakas, H. ^{[1
]}

Na, M. ^{[1
]}

Penning, T. M. ^{[10
]}

Ritacco, G. ^{[1
]}

Romine, J. ^{[1
]}

Sadekar, N. ^{[1
]}

Schultz, T. W. ^{[11
]}

Selechnik, D. ^{[1
]}

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 58109 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 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 Sch Med, Dept Dermatol, Journal Dermatol Sci JDS, Higashi Ku, 1-20-1 Handayama, Hamamatsu, Shizuoka 4313192, Japan

来源：

FOOD AND CHEMICAL TOXICOLOGY | 2020年 / 146卷

关键词：

D O I：

10.1016/j.fct.2020.111762

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. omega-Pentadecalactone was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from the target material and read-across analog ethylene dodecanedioate (CM # 54,982-831) show that omega-pentadecalactone is not expected to be genotoxic. Data provided a No Expected Sensitization Induction Level (NESIL) of 5500 mu g/cm(2) for the skin sensitization endpoint. Data from read-across analog oxacyclohexadecen-2-one (CAS # 34,902-57-3) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose and developmental and reproductive toxicity endpoints. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to omega-pentadecalactone is below the TTC (1.4 mg/day). The phototoxicity/photoallergenicity endpoints were evaluated based on data and UV spectra; omega-pentadecalactone is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; omega-pentadecalactone 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., PEC/PNEC), are <1.

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页数：10

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