Registration Dossier

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:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG. 6.14 (Ames-Test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
other: sat TA 98, 100, 1535, 1537
Metabolic activation:
with and without
Metabolic activation system:
ArocJor-induzierte Rattenleber S9-Mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 20 ... 5000 ~plate
Concentration range in the main test (without metabolic activation): 20 ... 5000 ~plate
Vehicle:
Solvent Aceton
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: 313 IJglplate

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
>5000 ug/plate
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Additional information on results:
negativewith metabolic activation
negative without metabolic activation

Applicant's summary and conclusion