Registration Dossier

Diss Factsheets

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
Guideline:
other: Annex V.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 Escherichia coli strain WP2uvrA-
Metabolic activation system:
Phenobarbitone/Beta-naphthoflavone induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 15 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 15 ... 5000 µg/plate
Vehicle / solvent:
Solvent: Tetrahydrofuran.
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 500 µg/plate

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)
Additional information on results:
Observations:
The vehicle and untreated control plates produced counts of
revertant colonies within the normal range.


The test material caused no visible reduction in the growth
of the bacterial background lawn at any dose level. The test
material was, therefore, tested up to the maximum
recommended dose level of 5000 microgr/plate.


An oily precipitate was observed at and above 500
microgr/plate. This did not prevent the scoring of revertant
colonies.


No significant increases in the frequency of revertant
colonies were recorded for any of the bacterial strains,
with any dose level of the test material, either with or
without metabolic activation.
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