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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:
other: Annex V (Ames)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain:
other: Salmonella typhimurium strains, TA 1535, TA 1537, TA 98 and TA 100 Escherichia coli, WP2 uvra (pKM101)
Metabolic activation system:
Liver preparations (S9 mix) from rats treated with phenobarbital and 5,6 - benzoflavone.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate
Vehicle:
Solvent: Water

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'.
Additional information on results:
Observations:
No signs of toxicity were observed towards the tester
strains in either mutation test following exposure to VRT-
753136 hcl.

No evidence of mutagenic activity was seen at any
concentration of VRT-753136 hcl in either mutation test.

The concurrent positive controls demonstrated the
sensitivity of the assay and the metabolising activity of
the liver preparations. The mean revertant colony counts for
the vehicle controls were within or close to the 99%
confidence limits of the current historical control range of
the laboratory.

Applicant's summary and conclusion

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