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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
Study period:
April 2006 - October 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Investigation using the Salmonella/microsome plate incorporation test for point mutagenic effects (Auxotrophic mutants - Rate of reversion to prototrophy is evaluated in negative control and treated groups).
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 102
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 rat liver S9-mix
Test concentrations with justification for top dose:
50, 158, 500, 1581, 5000 µg/plate with and without metabolic activation.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
0 µg/plate
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene for all strains
Remarks:
Sodium azide for TA 1535; Nitrofurantion for TA 100, 4-Nitro-1,2-phenylene diamine for TA 1537 and TA 98, Mitomycin C for TA 102 only used without S9 mix; 2-aminoanthracene only used with S9 mix.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Bacteriotoxic effects in the prelimniary as well as in the main test were seen (with and without metabolic activation) >1581 µg/plate.

SAT TA 1535 showed an increase in the mutant counts without metabolic activation, the lowest reproducible concentration was 158 µg/Plate.

Sat TA 1535 showed a weak mutagenic effect without metabolic activation which disappeared with metabolic activation, probably due to an impurity and not from the test substance itself.

Applicant's summary and conclusion

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