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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 TA1535, TA1537, TA98, and TA100 Escherichia coli, strain WP2 uvrA (pKM101).
Metabolic activation system:
Phenobarbital/5,6-benzoflavone induced rat liver S9
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: Dimethyl Sulphoxide

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-
126016.



The concurrent positive controls demonstrated the
sensitivity of the assay and the metabolising activity of
the liver preparations.

Applicant's summary and conclusion

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