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:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: OECD 471 and 472
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: TA 98, TA 100, TA 1535, TA 1537, Escherichia coli, CM891
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 rat liver S9-Mix
Test concentrations with justification for top dose:
Concentration range Main test with metabolic activation : 5 - 5000 µg/plate
Concentration range Main test without metabolic activation : 5 - 5000 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
mitomycin C
other: Ampicillin, 2-Aminofluorene, N-Ethyl-N'-Nitrosoguanidine (ENNG)

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation TA 98, TA 100, TA 1535, TA 1537, Escherichia coli, CM891
negative without metabolic activation TA 98, TA 100, TA 1535, TA 1537, Escherichia coli, CM891

It was concluded that the TS did not exhibit any mutagenic activity under the conditions of test.