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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 condidtions 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
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, 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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH; D-33178 Borchen
- Weight at study initiation: male 155 -161 g ; female 144 - 148
- Fasting period before study: overnight prior tor dose administration
- Housing: The animals were kept in Macrolon cages on Altromin saw fiber bedding
- Diet (e.g. ad libitum): Feeding ad libitum Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free-TPF
- Water (e.g. ad libitum): Free access to tap water ( drinking water, municipal residue control, microbiol. controlled periodically )
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 45 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 : 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations : clinical signs - twice a day on day of dosing and once a day thereafter
body weight - prior to first application and once a week thereafter
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No Mortality
- Clinical signs:
- other: No clinical signs of toxicity were observed throughout the observation period.
- Gross pathology:
- Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathological changes were found in all animals of step 1 and step 2.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Considering the reported data of this toxicity test it can be stated that the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" has no acute toxic characteristics.
The LD50 was determined to be > 2000 mg/kg bw. - Executive summary:
The acute toxic class method was performed with Nitropyridazinon synonymous to "Stufe, UDCG 115" . It is the principal of the acute toxic class method that, based on a stepwise procedure with the use of a minimum number of animals per step, sufficient information is obtained on the acute toxicity of the test item to enable its classification.
In the first step the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" was given in a dose of 2000 mg/kg body weight to a group of 3 male rats in a single exposure via oral gavage. In a second step the test item was given to 3 female rats in a single exposure via oral gavage.
The dosage of 2000 mg/kg body weight caused no compound-related mortality neither in the three male nor in the three female animals within the 14 days p. appl..
A careful clinical examination was made once a day. At the end of the observation period the animals were sacrificed and necropsy was carried out to record gross pathological changes. No clinical signs of toxicity were observed throughout the observation period.
Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathological changes were found in all animals of step 1 and step 2.
Therefore, according to OECD Guideline 423, a sufficient estimation of the acute oral toxicity of the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" is provided.
According to the results obtained the LD50 was determined to be > 2000 mg/kg bw.
Considering the reported data of this toxicity test it can be stated that the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" has no acute toxic characteristics.
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