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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Principles of method if other than guideline:
- ICH. Topic S2A Genotoxicity: Guidance on Specific Aspects
of Regulatory Genotoxicity Tests for Pharmaceuticals.
(CPMP/ICH/141/95) Step 4 Guideline (Approved September
1995).

- ICH. Topic S2B Genotoxicity: A Standard Battery for
Genotoxicity Testing of Pharmaceuticals. (CPMP/ICH/174/95)
Step 4 Guideline (Approved September 1997).
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) Escherichia coli WP2uvrA
Metabolic activation system:
phenobarbital and ß-naphthoflavone induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 100 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 100 ... 5000 µg/plate
Vehicle / solvent:
Solvent: Dimethyl sulfoxide

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Remarks on result:
other: other: preliminary test
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