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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
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:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V (Ames)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
414-380-4
EC Name:
-
Cas Number:
140681-55-6
Molecular formula:
C7H14B2ClF9N2
IUPAC Name:
1-(chloromethyl)-4-fluoro-1,4-diazabicyclo[2.2.2]octane-1,4-diium; bis(tetrafluoroboranuide)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium: TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation system:
Aroclor 1254-induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 10 ... 3333 μg/plate
Concentration range in the main test (without metabolic activation): .3 ... 5000 μg/plate
Vehicle / solvent:
Solvent: Deionised distilled water

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 3333 μg/plate)
Species / strain:
other: preliminary test
Metabolic activation:
without
Genotoxicity:
other: not applicable
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 667 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
other: not applicable
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 3333 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
other: not applicable
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 333 μg/plate)
Additional information on results:
Observations:
No significant increase in revertants were seen in any
strain.
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
positive without metabolic activation