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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: strains TA 98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Arochlor-induced rat liver
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): CA 24,69 .. , CA 2000 µg/plate
Concentration range in the main test (without metabolic activation): CA 24,69 ,.. CA 2000 µg/plate
Vehicle / solvent:
Solvent: DMSO
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 2000 µg/plate

Results and discussion

Additional information on results:
Observations:
No signs of toxicity at any concentration tested,
No reduction of background bacterial lawn at any concentration.
Positive controls gave the expected strong increase in the number of S9+ and S9- revertants,

Any other information on results incl. tables

negative with metabolic activation

negative without metabolic activation

Applicant's summary and conclusion

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