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: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006, without detailed documentation..

Data source

Reference
Reference Type:
other: Body responsible for test
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC Annex V (Ames test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

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:
Aroclor-induced rat liver S9.
Test concentrations with justification for top dose:
First main test with metabolic activation: 313->5.000 micrograms/plate
First main test without metabolic activation: 313->5.000 micrograms/plate
Second main test with metabolic activation: 50-5,000 micrograms/plate
Second main test without metabolic activation: 50-5,000 micrograms/plate

Vehicle:
Dimethyl sulphoxide
Controls
Solvent controls:
yes
Positive controls:
yes

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:
yes
Remarks:
> 5.000 micrograms/plate
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
> 5.000 micrograms/plate
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Appropriate positive control chemicals induced marked increases in revertant colony numbers with all strains. No increase in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to the test substance at concentrations from 313 to > 5,000 micrograms/plate (first main test) or 50 to 5,000 micrograms/plate (second main test) in either the presence or absence of S9 mix. The solvent control plates gave counts in the expected ranges.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation