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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Ames
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
his operon (S. typhimurium)
trp operon (E. coli)
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S 9 mix
Test concentrations with justification for top dose:
Experiment 1:
- with metabolic activation: 0, 50, 150, 500, 1500 and 5000 µg/plate
- without metabolic activation: 0, 50, 150, 500, 1500 and 5000 µg/plate

Experiment 2: Preincubation method
- with metabolic acitivation: 0, 50, 150, 500, 1500 and 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: distilled water
Controls
Untreated negative controls:
yes
Positive controls:
yes

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 5000 µg/plate
Positive controls validity:
valid
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 without metabolic activation
negative with metabolic activation

In a reverse gene mutation assay in bacteria strains S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 were exposed to 1,3-Dioxan-2-one (TMC) in distilled water at concentrations of 0, 50, 150, 500, 1500 and 5000 µg/plate in the presence and absence of mammalian metabolic activation.
The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.