Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC (Ames)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
other: Salmonella typhimurium TA1535, TA1537, TA1538, TA98, TA100 and Escherichia coli WP2 uvrA
Metabolic activation system:
Aroclor-induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 156.25 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 156.25 ... 5000 µg/plate
Vehicle:
Solvent: Dimethylsulfoxide

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
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
Genotoxicity:
negative
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
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
( 2500 µg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
( 2500 µg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Observations:
No increases in revertant colony numbers of any of the
tester strains were observed following treatment at any dose
level, in the presence or absence of S-9 mix. The solvent
control plates gave counts in the expected ranges. All
positive controls produced marked increases in the revertant
counts.

Applicant's summary and conclusion

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