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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:
key study
Study period:
9 October 1985 - 18 Octobre 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Principles and methods for their detections, modification mutagenic activity "Chemical Mutagens" T. Sugimura and M. Nagao, Vo1.6 pp.41-61 (1980) Plenum Press, (New York)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name: Acetyltetralin
Chemical name: 6-Acetyl-1,2,3,4-tetrahydronaphthalene
Appearance: colorless clear liquid

Method

Target gene:
Histidin
Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
0, 10, 25, 50, 70, 100, 250 and 500 micrograms
Controls
Positive controls:
yes
Positive control substance:
2-nitrofluorene
sodium azide
N-ethyl-N-nitro-N-nitrosoguanidine
other: 2-Aminoanthracene; 9-Aminoacridine hydrochloride
Details on test system and conditions:
After mixing the test m aterial, phosphate buffer or S-9 mix, culture of tester strain, the mixture was incubated under shaking at 37°C in a test tube for 20 minutes, top agar was added to the mixture and then the mixture was poured on minimal agar plate. The plates were incubated at 37°C for 2 days and scored for revertants.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Positive controls valid:
not specified
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Positive controls valid:
not specified
Additional information on results:
See attachment for result tables.

Applicant's summary and conclusion

Conclusions:
The mutagenic activity of the test item was tested by the in vitro direct and metabolic acitivation assays using Salmonella typhimurium TA100, TA1535, TA1537, TA98 and
Escherichia coli WP-2. The test results indicated that the compound is not mutagenic under the test system used.