RIFM fragrance ingredient safety assessment, 7,9-dimethylspiro[5.5]undecan-3-one, CAS Registry Number 83863-64-3.

Animals Dose-Response Relationship, Drug Humans Odorants Quantitative Structure-Activity Relationship Reproduction / drug effects Risk Assessment Toxicity Tests
And reproductive toxicity Developmental Environmental safety Genotoxicity Local respiratory toxicity Phototoxicity/photoallergenicity Repeated dose Skin sensitization

Journal

Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association
ISSN: 1873-6351
Titre abrégé: Food Chem Toxicol
Pays: England
ID NLM: 8207483

Informations de publication

Date de publication:
Mar 2021
Historique:
received: 12 10 2020
revised: 01 12 2020
accepted: 10 01 2021
pubmed: 19 1 2021
medline: 12 8 2021
entrez: 18 1 2021
Statut: ppublish

Résumé

The existing information supports the use of this material as described in this safety assessment. 7,9-Dimethylspiro[5.5]undecan-3-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 7,9-dimethylspiro[5.5]undecan-3-one is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class II material, and the exposure to 7,9-dimethylspiro[5.5]undecan-3-one is below the TTC (0.009 mg/kg/day, 0.009 mg/kg/day, and 0.47 mg/day, respectively). Based on the existing data and readacross material spiro[5.5]undec-8-en-1-one, 2,2,7,9-tetramethyl- (CAS # 502847-01-0), 7,9-dimethylspiro[5.5]undecan-3-one presents no concern for skin sensitization under the current, declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet (UV) spectra; 7,9-dimethylspiro[5.5]undecan-3-one is not phototoxic/photoallergenic. The environmental endpoints were evaluated; 7,9-dimethylspiro[5.5]undecan-3-one 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.

Identifiants

DOI: 10.1016/j.fct.2021.111993 PMID: 33460702
pubmed: 33460702
pii: S0278-6915(21)00027-2
doi: 10.1016/j.fct.2021.111993
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

111993

Informations de copyright

Copyright © 2021 Elsevier Ltd. All rights reserved.

Auteurs

A M Api (AM)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

D Belsito (D)

Member Expert Panel, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.

S Biserta (S)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

D Botelho (D)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

M Bruze (M)

Member Expert Panel, Malmo University Hospital, Department of Occupational & Environmental Dermatology, Sodra Forstadsgatan 101, Entrance 47, Malmo, SE, 20502, Sweden.

G A Burton (GA)

Member Expert Panel, School of Natural Resources & Environment, University of Michigan, Dana Building G110, 440 Church St., Ann Arbor, MI, 58109, USA.

J Buschmann (J)

Member Expert Panel, Fraunhofer Institute for Toxicology and Experimental Medicine, Nikolai-Fuchs-Strasse 1, 30625, Hannover, Germany.

M A Cancellieri (MA)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

M L Dagli (ML)

Member Expert Panel, University of Sao Paulo, School of Veterinary Medicine and Animal Science, Department of Pathology, Av. Prof. dr. Orlando Marques de Paiva, 87, Sao Paulo, CEP 05508-900, Brazil.

M Date (M)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

W Dekant (W)

Member Expert Panel, University of Wuerzburg, Department of Toxicology, Versbacher Str. 9, 97078, Würzburg, Germany.

C Deodhar (C)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

A D Fryer (AD)

Member Expert Panel, Oregon Health Science University, 3181 SW Sam Jackson Park Rd., Portland, OR, 97239, USA.

S Gadhia (S)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

L Jones (L)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

K Joshi (K)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

M Kumar (M)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

A Lapczynski (A)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

M Lavelle (M)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

I Lee (I)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

D C Liebler (DC)

Member Expert Panel, Vanderbilt University School of Medicine, Department of Biochemistry, Center in Molecular Toxicology, 638 Robinson Research Building, 2200 Pierce Avenue, Nashville, TN, 37232-0146, USA.

H Moustakas (H)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

M Na (M)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

T M Penning (TM)

Member of Expert Panel, University of Pennsylvania, Perelman School of Medicine, Center of Excellence in Environmental Toxicology, 1316 Biomedical Research Building (BRB) II/III, 421 Curie Boulevard, Philadelphia, PA, 19104-3083, USA.

G Ritacco (G)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

J Romine (J)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

N Sadekar (N)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

T W Schultz (TW)

Member Expert Panel, The University of Tennessee, College of Veterinary Medicine, Department of Comparative Medicine, 2407 River Dr., Knoxville, TN 37996- 4500, USA.

D Selechnik (D)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

F Siddiqi (F)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

I G Sipes (IG)

Member Expert Panel, Department of Pharmacology, University of Arizona, College of Medicine, 1501 North Campbell Avenue, P.O. Box 245050, Tucson, AZ, 85724-5050, USA.

G Sullivan (G)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA. Electronic address: gsullivan@rifm.org.

Y Thakkar (Y)

Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.

Y Tokura (Y)

Member Expert Panel, The Journal of Dermatological Science (JDS), Editor-in-Chief, Professor and Chairman, Department of Dermatology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › RIFM fragrance ingredient safety assessment,...
questionsmedicales.fr › Phénomènes physiologiques › Phénomènes pharmacologiques et toxicologiques › Phénomènes toxicologiques › Relation dose-effet des médicaments › RIFM fragrance ingredient safety assessment,...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › RIFM fragrance ingredient safety assessment,...
questionsmedicales.fr › Environnement et santé publique › Environnement › Odorisants › RIFM fragrance ingredient safety assessment,...
questionsmedicales.fr › Phénomènes physiologiques › Phénomènes pharmacologiques et toxicologiques › Phénomènes pharmacologiques › Relation structure-activité › Relation quantitative structure-activité › RIFM fragrance ingredient safety assessment,...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Reproduction › RIFM fragrance ingredient safety assessment,...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Probabilité › Risque › Appréciation des risques › RIFM fragrance ingredient safety assessment,...
questionsmedicales.fr › Techniques d'investigation › Tests de toxicité › RIFM fragrance ingredient safety assessment,...