Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
4 instead of 5 strains used
Qualifier:
according to
Guideline:
other: EEC Directive 92/69/EEC B.14. Salmonella typhimurium Reverse Mutation Test
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.1 %
Specific details on test material used for the study:
purity: 99.1 %

Method

Target gene:
Ames assay: detection of base pair substitutions and frameshift mutations
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9-mix of livers of adult male Sprague-Dawley rats pretreated with Aroclor 1254
Test concentrations with justification for top dose:
16, 50, 158, 500, 1581, 5000 µg per plate.
Vehicle / solvent:
DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: nitrofurantoin
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-1,2-phenylene diamine
Details on test system and experimental conditions:
plate incorporation and preincubation methodology
Evaluation criteria:
A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result
Statistics:
no data

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:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Summary of the results with N,N-Dibenzylamine in the Salmonella/Microsome Test Plate Incorporation Method:

 S9 Mix  TA 1535  TA 100  TA 1537  TA 98
 without  negative  negative  negative  negative
 with  negative  negative  negative  negative

Summary of the results with N,N-Dibenzylamine in the Salmonella/Microsome Test Plate Preincubation Method:

 S9 Mix  TA 1535  TA 100  TA 1537  TA 98
 without  negative  negative  negative  negative
 with  negative  negative  negative  negative

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
N,N-Dibenzylamine was tested in the Ames test according to the respective guideline (plate incorporation and preincubation methodology) in the presence and in the absence of amethbolic activation system using concentrations of up to and including 5000 µg/plate (cytotoxic) but evidence on mutagenic activity was not seen. Positive controls were functional. Therefore, N,N Dibenzylamine was considered to be non-mutagenic in the Ames test.