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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Additional strains: S. typhimurium TA 1538 and E. coli WP2 uvrA
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
100, 316, 1000, 3160, and 5000 µg/plate
Details on test system and experimental conditions:
Positive control: Sodium azide (without metabolic activation) --> TA1535, TA100
Positive control: 2-nitrofluorene (without metabolic activation) --> TA 98, TA 1538
Positive control: 9-amino-acridine ( without metabolic activation) --> TA1537
Positive control: 9-amino-acridine ( without metabolic activation) --> TA1537
Positive control: Methyl methane sulfonate ( without metabolic activation) --> WP2 uvr A
Positive control: 2-amino-anthracene (with metabolic activation) --> TA98, TA1537, TA1538
Positive control: Cyclophosphamide ( with metabolic activation) --> TA100, TA1535, WPS uvr A
Negative control: Dimethylsulfoxide (DMSO)

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 / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Additional information on results:
Note: TA 1538 and E. coli WP2 uvrA were also tested with and without metabolic activation; result: negative

Applicant's summary and conclusion

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

No mutagenic effect was observed for the test item in two independent experiments without and with metabolic activation.