Registration Dossier

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: Ames test, but without full study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Powder (grey)
- Storage condition of test material: Room temperature and humidity.

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
metabolic activation by liver extract (S-9) from rats treated with xenobiotics
Species / strain:
E. coli WP2 uvr A pKM 101
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
metabolic activation by liver extract (S-9) from rats treated with xenobiotics
Test concentrations with justification for top dose:
100 to 5000 µg / plate
Vehicle:
N/A
Controls
Solvent controls:
yes
Remarks:
Distilled Water
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Details on test system and conditions:
The test article was evaluated in an exploratory microbial mutation assay over a concentration range of 100 to 5000 µg / plate. Salmonella typhimurium test strains TA1535, TA97a, TA98, and TA100 and Escherichia coli test strain WP2 uvrA pKM101 were used, with and without metabolic activation (S-9 liver extract).
Evaluation criteria:
Positive result taken to be a 2-fold or greater increase in revertants relative to the solvent control.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
not examined
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
not examined
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
The results indicated that the test article, up to the highest tested concentration, did not produce any 2-fold or greater increases in revertants relative to the solvent control in any of the test strains, either with or without metabolic activation. The positive control, 2-aminoanthracene (2AA) produced the expected increases in revertants in all test strains in the presence of metabolic activation. No precipitate was noted on the plates at any concentration tested. Inhibition of bacterial lawn growth and revertant growth was noted at 3000 µg / plate and higher in most test strains.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test article was considered not to be mutagenic in this test system.
Executive summary:

The test article was evaluated in an exploratory microbial mutation assay over a concentration range of 100 to 5000µg / plate.Salmonella typhimurium test strains TA1535, TA97a, TA98, and TA100 and Escherichia colitest strain WP2 uvrA pKM101 were used, with and without metabolic activation (S-9 liver extract).

The results indicated that the test article, up to the highest tested concentration, did not produce any 2 -fold or greater increases in revertants relative to the solvent control in any of the test strains, either with or without metabolic activation. The positive control, 2-aminoanthracene (2AA) produced the expected increases in revertants in all test strains in the presence of metabolic activation. No precipitate was noted on the plates at any concentration tested. No precipitate was noted on the plates at any concentration tested. Inhibition of bacterial lawn growth and revertant growth was noted at 3000 µg / plate and higher in most test strains. In conclusion, the test article was considered not to be mutagenic in this test system.