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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Peer reviewed journal research article

Data source

Reference
Reference Type:
publication
Title:
Study of artificial flavouring substances for mutagenicity in the Salmonella/Microsome Basc and Micronucleus tests
Author:
D. Wild, M. T. King, E. Gocke and K. Eckhardt
Year:
1983
Bibliographic source:
Food and chemical toxicology, Vol. 21, 6, 707-719, 1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Deviations:
not specified
Principles of method if other than guideline:
The mutagenicity potential of α-Amylcinnamaldehyde by conducting experiment in Salmonella typhimurium TA1535, TA100, TA1537, TA1538 and TA 98.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-benzylideneheptanal
EC Number:
204-541-5
EC Name:
2-benzylideneheptanal
Cas Number:
122-40-7
Molecular formula:
C14H18O
IUPAC Name:
2-benzylideneheptanal
Test material form:
liquid
Details on test material:
Name of test material : (2E)-2-(phenylmethylidene)heptanal
Common name : 2-benzylideneheptanal
Molecular formula : C14H18O
Molecular weight : 202.2952 g/mol
Physical appearence: Liquid
Smiles notation : c1(\C=C(\CCCCC)C=O)ccccc1
InChl : 1S/C14H18O/c1-2-3-5-10-14(12-15)11-13-8-6-4-7-9-13/h4,6-9,11-12H,2-3,5,10H2,1H3/b14-11-
Substance type : Organic
Specific details on test material used for the study:
- Name of test material (as cited in study report): α-Amylcinnamaldehyde
- Molecular formula (if other than submission substance): C14H18O
- Molecular weight (if other than submission substance): 202.2952 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
other: Species: Salmonella typhimurium Strain: TA1535, TA100, TA1537, TA1538, TA98
Details on mammalian cell type (if applicable):
Not applicable.
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mixture from liver fraction of rat pretreated with Aroclor 1254
Test concentrations with justification for top dose:
Up to 3.6 mg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Solubility of test substance in DMSO solvent.
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
Details on test system and experimental conditions:
METHOD OF APPLICATION: Plate incorporation

DURATION
- Preincubation period: No data
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: Two

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
Rationale for test conditions:
No data
Evaluation criteria:
Dose dependent increase in number of revertants.
Statistics:
Kastenbaum and Bowman Method

Results and discussion

Test results
Species / strain:
other: Species: Salmonella typhimurium Strain: TA1535, TA100, TA1537, TA1538, TA98
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not valid
Positive controls validity:
valid
Additional information on results:
No data
Remarks on result:
other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:
The mutagenicity potential of α-Amylcinnamaldehyde was evaluated by performing mutagenicity assay in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538, TA98, test substance did not induce mutation in all bacterial tester strains. Therefore α-Amylcinnamaldehyde was considered to be not mutagenic in Salmonella typhimurium strains.
Executive summary:

The mutagenicity effect of α-Amylcinnamaldehyde was studied by performing experiment in Salmonella typhimurium. Salmonella typhimurium stains TA1535, TA100, TA1537, TA1538, TA98 were used in study. Mutagenic assay was performed by plate incorporation method with and without metabolic activation i.e. S9 mix prepared from liver fraction of Aroclor pretreated rats (Aroclor 1254). DMSO used as solvent for test substance. Five doses of each substance were tested (up to 3.6 mg/plate) in all five tester strains Vogel Bonnet medium was used throughout; plates were incubated for 48 hr. Positive controls were run in each experiment with the reference mutagens sodium azide and benzo[a]pyrene. Test substance was tested at least twice.

Test substance did not induce mutation in the tester strains, therefore α-Amylcinnamaldehyde was considered to be not mutagenic in Salmonella typhimurium strains.