Registration Dossier

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: OECD Guideline No. 471 EC Directive 92/69/EEC Annex V Test B.13, B.14 ICH Guidelines CPMP/ICH/141/95 Step 4 EPA Pesticide Assessment Guidelines, Sub-division F, 84-2
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain:
other: Salmonella typhimurium Strains TA1535, TA1537,TA98, TA100. Escherichia coli Strain WP2uvrA
Metabolic activation system:
Aroclor 1254 induced S9 fraction from rat liver preparation.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 10 ... 3333.3 µg/plateConcentration range in the main test (without metabolic activation): 10 ... 3333.3 µg/plate
Vehicle:
Solvent: Dimethyl sulphoxide (DMSO)
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: 1000 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity:
yes
Remarks:
(> 1667 µg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity:
yes
Remarks:
(> 1667 µg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity:
yes
Remarks:
(> 1000 µg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity:
yes
Remarks:
(> 1000 µg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Observations:Precipitation only resulted in the second mutation assay(pre-incubation method), in the presence of S9 mix.

Applicant's summary and conclusion

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