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EC number: 237-529-3 | CAS number: 13826-66-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-10-29 to 2014-11-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Zirconium dinitrate oxide
- EC Number:
- 237-529-3
- EC Name:
- Zirconium dinitrate oxide
- Cas Number:
- 13826-66-9
- Molecular formula:
- N2O7Zr
- IUPAC Name:
- nitric acid; oxozirconium
- Test material form:
- solid
- Details on test material:
- Name of test material (as cited in study report): zirconium dinitrate oxide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL:(WI) SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at dosing: young, healthy adult rats, 9-10 weeks old
- Weight at treatment: 208-233 g
- Fasting period before study: yes, the night before treatment, food but not water was withheld during an overnight period. Food was returned 3 hours after treatment.
- Housing: 3 animals per cage, in Type II polypropylene/polycarbonate cages with Lignocel Bedding for laboratory animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9-25.0°C
- Humidity (%): 30-70%
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2014-10-29 To: 2014-11-20
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: PBS (phosphate buffered saline)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 or 200 mg/mL (referring to anhydrous zirconium dinitrate oxide)
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The selection of the vehicle was made during trial formulation with the test item in distilled water and PBS at 3 concentrations that could be used for dosing 2000, 300 and 50 mg/kg as active ingredient (anhydrous zirconium dinitrate oxide). PBS was used further in the study, since the test item has an extremely low pH in distilled water.
- Lot/batch no. (if required): BCBJ5262V
- Purity: no data
- Expiry date: 2017-02-28
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual):
The test item was freshly formulated at a concentration of 200 or 30 mg/mL (as active ingredient, anhydrous zirconium dinitrate oxide) in the vehicle, in the Central Dispensary Unit of CiToxLAB Hungary Ltd. on the day of administration. The formulation container was stirred continuously up to finishing the treatment.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The initial dose level was most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose. - Doses:
- 2000 mg/kg bw in one group (as active ingredient) (anhydrous zirconium dinitrate oxide)
300 mg/kg bw in two groups (as active ingredient) (anhydrous zirconium dinitrate oxide) - No. of animals per sex per dose:
- 3 females per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor acitvity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter. Body weight of the animals found dead was recorded at necropsy
- Necropsy of survivors performed: yes. Macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia. After examination of external appearance, the cranial, thoracic and the abdominal cavities were opened and organs and tisses were observed. Macroscopic abnormalities were recorded. - Statistics:
- no data
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks:
- anhydrous zirconium dinitrate oxide
- Mortality:
- Mortality was observed in all animals receiving a single dose of 2000 mg/kg bw (3/3) on Day 1 or 2 or 4. No mortality was observed at the dose level of 300 mg/kg bw.
- Clinical signs:
- other: At 2000 mg/kg bw (expressed as anhydrous zirconium dinitrate oxide), the test item caused decreased activity (3/3), hunched back (3/3), incoordination (2/3), piloerection (2/3), dyspnoea (1/3), red discharge from the eye and around the nose (1/3). At 300
- Gross pathology:
- - In animals found dead (from 2000 mg/kg bw group): Diffuse red coloration of the glandular stomach mucosa found in 2/3 found dead females, was considered to be potentially test item-related. However, definitive attribution of this change to the test item cannot be made in absence of histopathological examination. The changes in the lungs were typical for found dead animals.
- In surviving animals: No macroscopic observations were seen at a dose level of 300 mg/kg bw. - Other findings:
- - Deviation from the study plan: Due to a typographical error, the pH value of the test item was reported to be 1.73 for the 7.35 mg/mL concentration in distilled water and 1.21 for the 294 mg/mL concentration in PBS in the Study plan. The correct values are 1.79 and 0.68, respectively. This deviation is considered to have no impact on the outcome of the study and interpretation of the results.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of zirconium dinitrate oxide was found to be between 300 and 2000 mg/kg bw in female CRL:(WI) rats. According to the GHS and CLP criteria, zirconium dinitrate oxide can be ranked as Category 4 for acute oral exposure.
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