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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:
weight of evidence
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:
Screening Of Tobacco Smoke Constituents For Mutagenicity Using The Ames' Test
Author:
Inger Florin , Lars Rutberg , Margareta Curvall And Curt R. Enzell
Year:
1980
Bibliographic source:
Toxicology, 18 (1980) 219-232

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Gene mutation toxicity study was performed to determine the mutagenic nature of the test compound Anisole
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Anisole
EC Number:
202-876-1
EC Name:
Anisole
Cas Number:
100-66-3
Molecular formula:
C7H8O
IUPAC Name:
methoxybenzene
Details on test material:
- Name of test material: Anisole
- IUPAC name: Anisole
- Molecular formula: C7H8O
- Molecular weight (if other than submission substance): 108.1392 g/mol
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material: Anisole
- IUPAC name: Anisole
- Molecular formula: C7H8O
- Molecular weight (if other than submission substance): 108.1392 g/mol
- Substance type: Organic
- Physical state: No data available
- Purity No data available
- Impurities (identity and concentrations): No data available

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Remarks:
LT-2 strains
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
Liver fraction (S-9) from Aroclor 1254 or methylcholanthrene induced rats
Test concentrations with justification for top dose:
3 µmole/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: The test chemical was soluble in ethanol and its role as a solvent control is not mentioned in the publication
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: N-methyl-N'-nitro-N-nitrosoguanidin (without metabolic activation) and 2-aminoanthracene (with activation)
Details on test system and experimental conditions:
METHOD OF APPLICATION: Spot test (in agar)

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

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

NUMBER OF REPLICATIONS: No data available

NUMBER OF CELLS EVALUATED: No data available

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

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available

OTHER: No data available
Rationale for test conditions:
No data
Evaluation criteria:
1. Increase in the number of spontaneous revertants
2. The presence of the rfa-mutation was checked by crystal violet inhibition;
3. The presence of the plasmid pKM 101 in strains TA 98 and TA 100 was checked by resistance to ampicillin
Statistics:
No data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: LT-2 strains TA 98, TA 100, TA 1535, and TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data
Remarks on result:
other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:
Anisole is not mutagenic in the bacterium Salmonella typhimurium LT-2 strains TA 98, TA 100, TA 1535, and TA 1537 with and without S9 metabolic activation system and hence is not likely to classify as gene mutant in vitro.
Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of the test compound Anisole using Salmonella typhimurium LT-2 strains TA 98, TA 100, TA 1535, and TA 1537. The material was dissolved in ethanol and applied at a concentration of 3 µmole/plate in the spot test performed.

Anisole is not mutagenic in the bacterium Salmonella typhimurium LT-2 strains TA 98, TA 100, TA 1535, and TA 1537 with and without S9 metabolic activation system and hence is not likely to classify as gene mutant in vitro.