Registration Dossier
Registration Dossier
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EC number: 437-930-5 | CAS number: 51553-03-8
Genetic toxicity: in vitro
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:
- 2001
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Ames Test in der Präinkubationsversion nach 2000/32/EG,
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 437-930-5
- EC Name:
- -
- Cas Number:
- 51553-03-8
- Molecular formula:
- Hill formula: C22H23N7O5 CAS formula: C22H23N7O5
- IUPAC Name:
- N-{5-[bis(2-methoxyethyl)amino]-2-[2-(2,6-dicyano-4-nitrophenyl)diazen-1-yl]phenyl}acetamide
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Uninduced hamster liver S9-Mix, modifications according to Prival and Mitchell (1982).
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 3.6 ... 356 µg/plate
Concentration range in the main test (without metabolic activation): 3.6 ... 356 µg/plate - Vehicle / solvent:
- Solvent: Dimethylsulfoxid
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 356 µg/plate
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (356 µg/plate)
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (356 µg/plate)
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 356 µg/plate)
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (356 µg/plate)
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (356 µg/plate)
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
In a preliminary toxicity test the test substance showed
toxicity (reduction in background lawn and number of
revertants) at 3560 µg/plate with strains TA98 and TA 1537
without metabolic activation. Also with strains TA 100, TA
102 und TA 1535 (all without S9) a complete reduction of
background lawn was observed.
Main tests (preincubation method):
The test substance induced a strong and dose dependant
increase of revertants in all strains except TA 102 with as
well without metabolic activation. The highest increase
was observed with strain TA98: 95fold increase of
revertants as compared to negative controls with and
without metabolic activation. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
positive without metabolic activation
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