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EC number: 846-827-8 | CAS number: 1521274-68-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The applied test method is a modified version of the Ames test (OECD 471), designated Ames II Assay (microtiter version). The method is used to evaluate the mutagenic potential of the test chemical based on the ability to induce point mutations in selected loci of several strains of Salmonella typhimurium, both with and without the addition of a metabolizing system (S9 mix).
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-ethylpyridazin-4-amine
- EC Number:
- 846-827-8
- Cas Number:
- 1521274-68-9
- Molecular formula:
- C6H9N3
- IUPAC Name:
- N-ethylpyridazin-4-amine
- Details on test material:
- - State of aggregation: solid/brown
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium, other: TA Mix (TA 7001 - TA 7006)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: induced male Wistar rats
- volume of S9 mix in the final culture medium: 40 µL S9 mix + 200 µL Bacteria suspension + 10 µL Test substance or vehicle or positive control
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability) - Test concentrations with justification for top dose:
- Doses: 0; 4; 20; 100; 500; 2500 and 5000 µg/mL
- Vehicle / solvent:
- - Vehicle used: DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: 2
- Number of independent experiments: 3
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): Bacteria suspension OD > 2.0 (600 nm) mixed with Ames II Exposure medium (1:6)
- Test substance added in medium: 10 µL/250 µL
TREATMENT
- duration of treatment: 90 min
- 48 h incubation with Ames II Reversion indicator medium - Evaluation criteria:
- Evaluation was performed by the following comparisons/calculation:
- An increase in the mean number of positive wells in dose groups was compared to the
mean value of the concurrent negative control (Evaluation factor 1 F).
- An increase in the mean of revertant wells in dose groups was calculated on the basis
of the baseline data of the actual experiment (Evaluation factor 2 F). The baseline was
derived from the mean spontaneous revertant number plus the value of standard
deviation (mean + SO) from the distribution of spontaneous data.
- An increase in the mean of revertant wells in dose groups was calculated on the basis
of the baseline data of an experimental run (Evaluation factor 3 F). A run consists of a
variable number of experiments generally testing different test substances together
each using the same vehicle control. This leads to an accumulation of replicates for
negative controls which was used to calculate the mean spontaneous reversion
number for each run.
A test substance is considered mutagenic in this test system if more than a doubling of
Evaluation factor 3 F is observed in at least one test group.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA Mix (TA 7001 - TA 7006)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions, the test substance did not show a mutagenic potential in the Ames II Assay (Salmonella typhimurium reverse mutation assay), both with or without metabolic activation.
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