RIFM fragrance ingredient safety assessment, dihydromyrcene, CAS Registry Number 2436-90-0

被引：0

作者：

Api, A. M. ^{[1
]}

Belsito, D. ^{[2
]}

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
]}

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. ^{[11
]}

Schultz, T. W. ^{[1
]}

Selechnik, D. ^{[1
]}

Siddiqi, F. ^{[12
]}

Sipes, I. G. ^{[1
]}

Sullivan, G. ^{[1
]}

Thakkar, Y. ^{[1
]}

Tokura, Y. ^{[13
]}

机构：

[1] Res Inst Fragrance Mat Inc, 50 Tice Blvd, Woodcliff Lake, NJ 07677 USA

[2] Columbia Univ Med Ctr, Dept Dermatol, Expert Panel, 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 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, 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 Sch Med, Dept Dermatol, Higashi Ku, 1-20-1 Handayama, Hamamatsu, Shizuoka 4313192, Japan

来源：

FOOD AND CHEMICAL TOXICOLOGY | 2022年 / 159卷

关键词：

BETA-MYRCENE; PERSONAL CARE; DEVELOPMENTAL TOXICITY; CONSUMER EXPOSURE; MODEL; ABSORPTION; COSMETICS; THRESHOLD;

D O I：

10.1016/j.fct.2021.112642

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. Dihydromyrcene was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from dihydromyrcene and read-across analog myrcene (CAS # 123-35-3) show that dihydromyrcene is not expected to be genotoxic. Data on read-across material myrcene (CAS # 123-35-3) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints. Data from dihydromyrcene provided a No Expected Sensitization Induction Level (NESIL) of 10000 mu g/cm(2) for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV/Vis) spectra; dihydromyrcene is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the TTC for a Cramer Class I material, and the exposure to dihydromyrcene is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; dihydromyrcene 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.

引用

页数：10

共 47 条

[1] The FEMA GRAS assessment of aliphatic and aromatic terpene hydrocarbons used as flavor ingredients
Adams, T. B.
Gavin, C. Lucas
McGowen, M. M.
Waddell, W. J.
Cohen, S. M.
Feron, V. J.
Marnett, L. J.
Munro, I. C.
Portoghese, P. S.
Rietjens, I. M. C. M.
Smith, R. L.
[J]. FOOD AND CHEMICAL TOXICOLOGY, 2011, 49 (10) : 2471 - 2494
[2] [Anonymous], 2015, Guidance Document on Revisions to OECD Genetic Toxicology Test Guidelines
[3] [Anonymous], 2015, Estimation Programs Interface SuiteTRADE
[4] for Microsoft Windows, v 4.11
[5] [Anonymous], 2012, Guidance on information requirements and chemical safety assessment, Chapter R.8: characterisation of dose concentration-response for human health
[6] Api A M, 2015, Food Chem Toxicol, V82 Suppl, pS1, DOI 10.1016/j.fct.2014.11.014
[7] Updating exposure assessment for skin sensitization quantitative risk assessment for fragrance materials
Api, Anne Marie
Basketter, David
Bridges, James
Cadby, Peter
Ellis, Graham
Gilmour, Nicola
Greim, Helmut
Griem, Peter
Kern, Petra
Khaiat, Alain
O'Brien, John
Rustemeyer, Thomas
Ryan, Cindy
Safford, Bob
Smith, Benjamin
Vey, Matthias
White, Ian R.
[J]. REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2020, 118
[8] Bauter M.R., 2013, 73535 RIFM
[9] Scientific Opinion on Flavouring Group Evaluation 78, Revision 2 (FGE.78Rev2): Consideration of aliphatic and alicyclic and aromatic hydrocarbons evaluated by JECFA (63(rd) meeting) structurally related to aliphatic hydrocarbons evaluated by EFSA in FGE.25Rev3
Bolognesi, Claudia
Castle, Laurence
Cravedi, Jean-Pierre
Engel, Karl-Heinz
Fowler, Paul
Grob, Konrad
Guertler, Rainer
Husoy, Trine
Mennes, Wim
Milana, Maria Rosaria
Penninks, Andre
Pocas, Maria de Fatima Tavares
Silano, Vittorio
Smith, Andrew
Tlustos, Christina
Toldra, Fidel
Woelfle, Detlef
Zorn, Holger
[J]. EFSA JOURNAL, 2015, 13 (04)
[10] Exposure based waiving: The application of the toxicological threshold of concern (TTC) to inhalation exposure for aerosol ingredients in consumer products
Carthew, P.
Clapp, C.
Gutsell, S.
[J]. FOOD AND CHEMICAL TOXICOLOGY, 2009, 47 (06) : 1287 - 1295

← 1 2 3 4 5 →