RIFM fragrance ingredient safety assessment, 3-phenylbutanal, CAS Registry Number 16251-77-7

被引：0

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, Med Ctr, 161 Ft Washington Ave, New York, NY 10032 USA

[3] Malmo Univ Hosp, Dept Occupat & Environm Dermatol, Sodra Forsmdsgatan 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 II-III,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 / 144卷

关键词：

Genotoxicity; Repeated dose; Developmental; Reproductive toxicity; Skin sensitization; Phototoxicity/Photoallergenicity; Local respiratory toxicity; Environmental safety; PERSONAL CARE; CONSUMER EXPOSURE; MODEL; ABSORPTION; COSMETICS; THRESHOLD; TOXICITY;

D O I：

10.1016/j.fct.2020.111528

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. 3-Phenylbutanal 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 isopropylphenylbutanal (CAS # 125109-85-5) show that 3-phenylbutanal is not expected to be genotoxic. Data from read-across analog 2-phenylbutanal (CAS # 93-53-8) provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on the target material provided a No Expected Sensitization Induction Level (NESIL) of 5900 pg/cm 2 for the skin sensitization endpoint. The developmental and reproductive toxicity and local respiratory toxicity endpoints were completed using the threshold of toxicological concern (TTC) for a Cramer Class I material (0.03 mg/ kg/day and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoint was completed based on ultraviolet (UV) spectra; 3-phenylbutanal is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 3-phenylbutanal 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：9

共 51 条

[1]

[Anonymous], 2015, Guidance Document on Revisions to OECD Genetic Toxicology Test Guidelines

[2]

[Anonymous], 2015, Estimation Programs Interface SuiteTRADE

[3]

for Microsoft Windows, v 4.11

[4]

[Anonymous], 2012, Updated guidance on information requirements and chemical safety assessment for nanomaterials from

[5]

Api A M, 2015, Food Chem Toxicol, V82 Suppl, pS1, DOI 10.1016/j.fct.2014.11.014

[6] Exposure based waiving: The application of the toxicological threshold of concern (TTC) to inhalation exposure for aerosol ingredients in consumer products [J].

Carthew, P. ;

Clapp, C. ;

Gutsell, S. .

FOOD AND CHEMICAL TOXICOLOGY, 2009, 47 (06) :1287-1295

[7] CAESAR models for developmental toxicity [J].

Cassano, Antonio ;

Manganaro, Alberto ;

Martin, Todd ;

Young, Douglas ;

Piclin, Nadege ;

Pintore, Marco ;

Bigoni, Davide ;

Benfenati, Emilio .

CHEMISTRY CENTRAL JOURNAL, 2010, 4

[8] Integrating habits and practices data for soaps, cosmetics and air care products into an existing aggregate exposure model [J].

Comiskey, D. ;

Api, A. M. ;

Barrett, C. ;

Ellis, G. ;

McNamara, C. ;

O'Mahony, C. ;

Robison, S. H. ;

Rose, J. ;

Safford, B. ;

Smith, B. ;

Tozer, S. .

REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2017, 88 :144-156

[9] Novel database for exposure to fragrance ingredients in cosmetics and personal care products [J].

Comiskey, D. ;

Api, A. M. ;

Barratt, C. ;

Daly, E. J. ;

Ellis, G. ;

McNamara, C. ;

O'Mahony, C. ;

Robison, S. H. ;

Safford, B. ;

Smith, B. ;

Tozer, S. .

REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2015, 72 (03) :660-672

[10]

ECHA, 2014, REG DOSS 3 PHEN

← 1 2 3 4 5 6 →