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EC number: 616-053-3 | CAS number: 74149-73-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions according to OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-methoxy-N-[4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)-2-nitrophenyl]benzamide
- EC Number:
- 616-053-3
- Cas Number:
- 74149-73-8
- Molecular formula:
- C19 H18 N4 O5
- IUPAC Name:
- 4-methoxy-N-[4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)-2-nitrophenyl]benzamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Nitropyridazinon synonymous to "Stufe A, UDCG 115"
- Physical state: solid
- Analytical purity: 99.0 %
- Purity test date: 02 August 2001
- Lot/batch No.: RH 1/1 - 1/23
- Expiration date of the lot/batch: August 2002
- Storage condition of test material: at room temperature, in the dark
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 31.6 , 100.0, 316.2, 1000.0, 2500.0 and 5000.0 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-o-phenylene-diamine ; 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- A test item is considered as mutagenic if : - a dose-related increase in the number of revertant occurs and/or
- a reproducible biologically relevant positive response for at least one of the test points occurs
in at least one strain with or without metabolic activation.
A biologically relevant increase is described as follows : - if in strain TA 100 the numbers of reversions is at least twice as high
- if in strain TA 98 the number of reversions is at least three times higher
as compared to the spontaneous rate.
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:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. - Executive summary:
In order to investigate the potential of Nitropyridazinon synonymous to "Stufe, UDCG 115" for its ability to induce gene mutations the plate incorporation test ( experiment I ) and the pre-incubation test ( experiment II ) were performed with Salmonella typhimurium strains TA 98 and TA 100.
The test item was tested in two independent experiments at several concentrations. Each assay was conducted with and without metabolic activation (S9 mix ). The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments : 31.6, 100.0, 316.2, 1000.0, 2500.00 and 5000.0 µg/plate
No toxic effects of the test item were observed in all tester strains in the experiment up to the highest investigated dose neither with nor without metabolic activation.
No substantial increases in the revertant colony numbers of any of the two tester strains were detected at any dose level of the test item neither with or without metabolic activation in both independently performed experiments.
As positive controls reference mutagens were tested in parallel to the test item. They showed a distinct increase of induced revertant colonies.
The reported data of this mutagenicity test show that the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, Nitropyridazinon synonymous to "Stufe, UDCG 115" is considered to be non-mutagenic in this bacterial reverse mutation assay.
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