Registration Dossier
Registration Dossier
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EC number: 485-290-0 | CAS number: 3021-02-1
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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 2000/32/EG, B.13, B.14 (Ames-Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 485-290-0
- EC Name:
- -
- Cas Number:
- 3021-02-1
- Molecular formula:
- C2H8N10
- IUPAC Name:
- 5-(1H-1,2,3,4-tetrazol-5-yl)-1H-1,2,3,4-tetrazole diamine
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: histidine dependent
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S-9 mix.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 4 ... 403 µg/plate
Concentration range in the main test (without metabolic activation): 4 ... 403 µg/plate - Vehicle / solvent:
- Solvent: deionised water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- historical data
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine, Sodium azide, Benzo(a)pyrene, 2-Aminoanthracene (2-AA
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
- Remarks:
- (> 403 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: main test
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test item BHT-2NH3 5,5'-Bis-1H-tetrazole diammonium salt is considered as "not mutagenic under the conditions of the test".
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