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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:
weight of evidence
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed publication

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:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
The mutagenic potential of 4-(4-Methoxyphenyl)butan-2-one (Anisyl acetone) was determned by conducting experiment using Salmonella typhimurium TA1535, TA100, TA1537, TA1538 and TA 98.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: 4-(4-Methoxyphenyl)butan-2-one (Anisyl acetone)
- IUPAC name: 4-(4-methoxyphenyl)butan-2-one
- Molecular formula: C11H14O2
- Molecular weight: 178.23 g/mol
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material: 4-(4-Methoxyphenyl)butan-2-one (Anisyl acetone)
- IUPAC name: 4-(4-methoxyphenyl)butan-2-one
- Molecular formula: C11H14O2
- Molecular weight: 178.23 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:
S. typhimurium, other: 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
Remarks:
DMSO
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: In agar (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:
The plates were observed for a dose dependent increase in number of revertants.
Statistics:
Statistical significance was determined according to the methods of Kastenbaum & Bowman

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
4-(4-Methoxyphenyl)butan-2-one (Anisyl acetone) did not induce gene mutation in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538, TA98, test substance in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant.
Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of 4-(4-Methoxyphenyl)butan-2-one (Anisyl acetone). The study was perfomed as per the standard plate procesdure using Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538, TA98 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in DMSO and used upto doses of 3.6 mg/plate. The plates were incubated for 48 hrs. 4-(4-Methoxyphenyl)butan-2-one (Anisyl acetone) did not induce gene mutation in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538, TA98, test substance in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant.