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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:
4.1.2001 - 22.1.2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
10-methoxy-5H-dibenz[b,f]azepine
EC Number:
225-172-6
EC Name:
10-methoxy-5H-dibenz[b,f]azepine
Cas Number:
4698-11-7
Molecular formula:
C15H13NO
IUPAC Name:
10-methoxy-5H-dibenzo[b,f]azepine

Method

Target gene:
his and trp
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2uvrA
Metabolic activation:
with and without
Metabolic activation system:
Rat liver microsomal enzymes (S9-mix)
Test concentrations with justification for top dose:
10, 33, 100, 333 and 1000 µg/plate
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9: sodium azide (TA1535), 9-aminoacridine (TA1537), daunomycine (TA98), methylmethanesulfonate (TA100), 4-nitroquinoline (WP2uvrA); +S9: 2-aminoanthracene (all strains)

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:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
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

The test substance did not induce a dose-related, two-fold, increase in the number of revertant colonies in each of the four Salmonella strains (TA1535, TA1537, T498 and TA100) and in the number of revertant colonies in the E. coli strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. Cytotoxicity was observed at 1000 µg/plate in the tester strains TA 1537, TA 98 and TA 100 with and without metabolic activation in both experiments. Precipitation of the test substance was observed in both experiments at concentrations of 333 µg/plate and above in TA 1535, TA 1537 and TA 98 with and without metabolic activation. For tester strains TA 100 and WP2uvrA, precipitation was observed at 1000 µg/plate in experiment 1 and at 333 µg/plate and above in experiment 2, each with and without metabolic activation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative