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)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG, B.13, B.14
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
no data
Species / strain
Species / strain:
other: sat TA 98, 100, 1535, 1537; esc WP2 uvrA
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9 fraction.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation):3...5000 μg/plate
Concentration range in the main test (without metabolic activation):3...5000 μg/plate
Vehicle:
Solvent: Dimethylsulfoxide
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: 50 μg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The data of the genotoxicity is not available.

Applicant's summary and conclusion

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