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:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
The First Evaluation and Registration Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfar ed., Commentary on the Guidelines for toxicity studies of drugs, 1990, pp. 30-40. The Yakuji Nippo Co. Ltd. (1990) (se basant sur la Directive 92/69/CEE, B.13/14)
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 TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 313 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 313 ... 5000 μg/plate
Vehicle / solvent:
Solvent: eau distillée

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 5000 μg/plate
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 5000 μg/plate
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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