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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication/ study report which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999
Reference Type:
secondary source
Title:
Fragrance material review on methyl ionone (mixture of isomers)
Author:
Lalko J et al.
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S300–S307
Reference Type:
secondary source
Title:
A toxicologic and dermatologic assessment of ionones when used as fragrance ingredients
Author:
Belsito D et al.
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S130–S167
Reference Type:
secondary source
Title:
Robust Summaries For lonone Derivatives
Author:
Wagner III VO and Caruthers SM
Year:
2002
Bibliographic source:
The Flavor and High Production Volume Consortia and The Terpene Consortium

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Remarks:
Wagner III VO and Caruthers SM
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Ionone, methyl-
EC Number:
215-635-0
EC Name:
Ionone, methyl-
Cas Number:
1335-46-2
Molecular formula:
C14H22O
IUPAC Name:
Ionone, methyl-

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-1254 induced rat liver S9 mix
Test concentrations with justification for top dose:
in the preliminary mutagenicity test: <= 5000 µg/plate methyl ionone
in the mutagenicity assay: 25 - 5000 µg/plate methyl ionone
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 667 and 5000 µg/plate methyl ionone
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 1000 and 3333 µg/plate methyl ionone
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 1000 and 3333 µg/plate methyl ionone
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 1800 µg/plate methyl ionone
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 1800 µg/plate methyl ionone
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Phase I: preliminary toxicity study: Concentrations at which cytotoxicity was oserved [µg/plate]

(converse results of two sources)

Results of FFHPVC Terpene Consortium:

   TA 98  TA 100  TA 1535  TA 1537  WP2 uvr A
 - S9    5000  3333  3333  
 + S9    667  1000  1000  

Results of RIFM monograph:

   TA 98  TA 100  TA 1535  TA 1537  WP2 uvr A
 - S9   >= 6667 >= 1000 >= 1000  
 + S9   >= 5000 >= 3333 >= 3333  

Phase II: mutagenicity study

(concordant results of two sources)

no evidence of mutagenicity.

Toxicity observed at concentrations of 1800 µg/plate with TA 100 and TA 1537.

Applicant's summary and conclusion