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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: Limited data available on methods and results, no guidelines and no GLP.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No data given.

Method

Target gene:
Histidine gene in S. typhimurium
Tryptophan gene in E. coli
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
0.033, 0.1, 0.33, 1.0, 3.3 and 10 mg/plate.
Vehicle / solvent:
0.067M potassium or sodium phosphate buffer (pH 7.0)
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-anthramine
Remarks:
In the presence of S9 mix for all strains.
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
In the absence of S9 mix for strains TA 98 and TA 1538.
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
In the absence of S9 mix for strains TA100 and TA1535.
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
In the absence of S9 mix for strain TA1537.
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
furylfuramide
Remarks:
In the absence of S9 mix for strain E. coli WP2.

Migrated to IUCLID6: or N-methyl-N'-nitro-N-nitrosoguanidine
Details on test system and experimental conditions:
The standard S. typhimurium plate-incorporation assay was performed in the presence and in the absence of S9 mix, contained 10% Aroclor 1254 induced liver S9 from male Sprague-Dawley rats. The E. coli test was performed by the same procedure as the S. typhimurium assay except that each liter of base agar was supplemented with 10 ml (1% v/v) of Oxoid nutrient broth to provide a trace of tryptophan.
Evaluation criteria:
Test results were considered valid only if the positive control compounds induced increases in mutant counts to at least twice background.
Statistics:
None stated.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without S9

Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Reliability of this study can be demonstrated as 2 (reliable with restrictions) due to limited data available on methods and results, no guidelines and no GLP.
Executive summary:

Reverse mutation assays using S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537, TA 1538 and E. coli WP2 were carried out with and without metabolic activation system of S9 mix. The test was performed using doses of 0.033, 0.1, 0.33, 1.0, 3.3 and 10 mg/plate. All platings were performed in duplicate and concurrent positive controls were run with the test.

The negative result indicated that the test substance was not mutagenic in any tested S. typhimurium and E. coli strains with or without metabolic activation.

Reliability of this study can be demonstrated as 2 (reliable with restrictions) due to limited data available on methods and results, no guidelines and no GLP.