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
Study period:
November 12 – 20, 1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Appearance: whitish powder
Storage conditions: at room temperature

Method

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:
S9 mix
Test concentrations with justification for top dose:
Test article dosage levels
The test article dosage leves,espresse as quantities of substance per plate, were the following:
- 50, 150, 500, 1500 and 5000 µg/plate
- 15, 50, 150, 500 and 1500 µg/plate

Preparation of the test article solutions
In each experiment, an exact amount of the test article DTZ 62 was dissolved in dimethyl sulfoxide and further diluted in the same solvent to give the following concentrations:
- 50,15, 5, 1.5 and 0.5 mg/ml
- 15, 5, 1.5, 0.5 and 0.15 mg/ml
Vehicle / solvent:
Dimethyl sulfoxide
Controls
Untreated negative controls:
yes
Remarks:
Dimethyl sulfoxide
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulfoxide
Positive controls:
yes
Remarks:
Hydrazine sulphate, 9-aminoacridine HCl monohydrate, Mitomycin C, Doxorubicine HCl, 2-Aminofluorene
Details on test system and experimental conditions:
Tester strain storage and control
The S. typhimurium strain were stored in growth medium plus 25 µg/ml ampicillin and 8% dimethyl sulphoxide, at -80°C.
Fresh bacterial cultures were subcultivated on complete medium and stored in a refrigerator for up to 1 month, except TA102 S. typhimurium strain which was stored for up to 2 weeks.
Both permanent cultures and Master plates were checked to confirm the tester strain genotype.
The liquid culture used to prepare Master plates or the first overnight cultures from fresh Master plates was submitted to the following controls.

Results and discussion

Test resultsopen allclose all
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
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In the concentration range investigated, the test substance did not show any mutagenic activity with or without the addition of S9 liver homogenate fractions.