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:
4 (not assignable)

Data source

Reference
Reference Type:
other: extracted from ECHA database
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Principles of method if other than guideline:
Annex V, B.14 (Ames test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation system:
Aroclor-induced rat liver S9
Species / strain:
S. typhimurium TA 1538
Test concentrations with justification for top dose:
Main test
with metabolic activation: 8... 5000 ug/plate
without metabolic activation: 8... 5000 ug/plate
Vehicle:
DMSO

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as stated above
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
> 5000 ug/plate
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as stated above
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
> 5000 ug/plate
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Additional information on results:
The solvent control plates gave counts of revertant colonies within the normal range.
All positive control chemicals gave increases in revertants, either with or without metabolising system as appropriate, within expected ranges.
No significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose of the substance either with or without metabolic activation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The substance was found to be non-mutagenic under the conditions of the test.