Registration Dossier
Registration Dossier
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EC number: 425-450-9 | CAS number: 294-90-6
Genetic toxicity: in vitro
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
Data source
Reference
- Reference Type:
- other: Body responsible for the test.
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.14 (Ames-Test)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 425-450-9
- EC Name:
- -
- Cas Number:
- 294-90-6
- Molecular formula:
- C8H20N4
- IUPAC Name:
- 1,4,7,10-tetraazacyclododecane
- Test material form:
- not specified
- Details on test material:
- - Substance name: 1,4,7,10-tetraazacyclododecane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- Not used
- Metabolic activation:
- with and without
- Metabolic activation system:
- "DEUSTCH" Leberhomogenat von mit Aroclor 1254 behandelten Ratten. "ENGLISH" Liver homgenat from Aroclor 1254 treated rats.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 3 ... 3330 μg/plateConcentration range in the main test (without metabolic activation): 3 ... 3330 μg/plate
- Vehicle / solvent:
- Solvent: DMSO
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1000 μg/plate)
- Key result
- Species / strain:
- other: As specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1000 μg/plate)
- Key result
- Species / strain:
- other: As specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1000 μg/plate)
- Additional information on results:
- None
- Remarks on result:
- other: Preliminary test
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test substance is not mutagenic in the tested TA 98,100, 1535 and 1537 Salmonella typhimurium strains.
- Executive summary:
The test substance mutagenicity study was performed according to the 92/69/EWG, B.14 (Ames-Test) Guideline under GLP conditions.
Several concentrations of test substance ranging from [3 -3330 μg/plate] were tested in TA 98,100, 1535 and 1537 Salmonella typhimurium strains with and without metabolic activation ( Liver homgenat from Aroclor 1254 treated rats ).
Under the test conditions, the test substance is not mutagenic in the tested TA 98,100, 1535 and 1537 Salmonella typhimurium strains with and without metabolic activation. Test substance caused cytotoxic effect at concentrations >1000µg/plate.
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