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

Data source

Reference
Reference Type:
other: SNIF file
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with
Metabolic activation system:
AROCLOR-induced rat liver S9-mix
Test concentrations with justification for top dose:
concentration range in the main test (with metabolic activation): 313 ... 5000 µg/plate
concentration range in the main test (without metabolic activation): 313 ... 5000 µg/plate
Vehicle / solvent:
solvent: DMSO (suspension 50 mg)

Results and discussion

Any other information on results incl. tables

Neither in the original nor in the confirmatory experiment with and without metabolic activation mutagenic effects were observed.

Applicant's summary and conclusion

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

The presented data were accepted by authorities in the context of substance notification according to the Council Directive 67/548/EEC.