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Diss Factsheets
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EC number: 234-963-5 | CAS number: 12045-64-6
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2016-04-27 to 2016-05-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Zirconium diboride
- EC Number:
- 234-963-5
- EC Name:
- Zirconium diboride
- Cas Number:
- 12045-64-6
- Molecular formula:
- ZrB2
- IUPAC Name:
- zirconium diboride
- Test material form:
- solid: particulate/powder
- Details on test material:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ZrB2-3.2/14
- Expiration date of the lot/batch: 04 March 2017
- Purity: 99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25 ºC, below 70% relative humidity), protected from light and humidity
OTHER SPECIFICS:
Description: Grey powder (the colour was determined by visual inspection upon arrival at test facility)
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personal health and safety.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:(WI) rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Sandhofer Weg 7, D97633 Sulzfeld, Germany
- Age at study initiation: 9 weeks old
- Weight at study initiation: 201 – 213 g
- Fasting period before study: The night before treatment the animals were fasted for a maximum of 16 hours. Food, but not water, was withheld overnight.
- Housing: Group housing of 3 animals per cage. Cage type: Type II. polypropylene/polycarbonate. Bedding: “Lignocel 3/4-S Hygienic Animal Bedding” and “Arbocel crinklets natural” nest building material produced by J. Rettenmaier & Söhne GmbH & Co.KG (D-73494 Rosenberg, Germany).
- Diet (e.g. ad libitum): ad libitum, free access to rodent diet
- Water (e.g. ad libitum): ad libitum, free access to tap water
- Acclimation period: 13-14 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6-23.9 °C
- Humidity (%): 26-70%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 1% in distilled water
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: The selection of the vehicle was based on trial formulations with the test item. In order of preference, the recommended vehicles were the following: distilled water, 0.5 or 1% methyl cellulose or carboxymethylcellulose, PEG 400, corn oil, sunflower oil or DMSO. Trial formulations with distilled water caused a noticeably rapidly settling formulation, therefore it was considered as not suitable for treatments. Consequently, 1% methyl cellulose was also tried as a vehicle, which resulted in an acceptably stable formulation, suitable for treatments.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION:
Test item was freshly formulated at a concentration of 200 mg/mL in the vehicle in the Pharmacy of CiToxLAB Hungary Ltd. on the day of administration. The stability and concentration in the vehicle was not determined.
However, to limit the impact, the formulations were used within 4 hours after adding the vehicle to the test item and the test item preparation was performed with approved procedures and documented in detail. The formulation was homogenised to visually acceptable levels and was stirred up to finishing the treatment to ensure sufficient homogeneity. No correction was made for the purity/composition of the test item.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
The initial dose level was selected by the Study Director to be that which is 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. The limit dose (= starting dose level) for this study was 2000 mg/kg bw. - Doses:
- 2000 mg/kg (single dosage). A second test at the same dose level was perfomed.
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (dosing on day 0)
- Frequency of observations and weighing:
* mortality/viability: not explicitly mentioned
* body weights: on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter
* clinical signs: after dosing at 30 minutes, then 1, 2, 3, 4 and 6 hours after the treatment and once each day in the morning for 14 consecutive days thereafter
* individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern; particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma
- Necropsy of survivors performed: Yes, all animals were subjected to a necropsy and a macroscopic examination. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All gross macroscopic changes were recorded for each animal. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Zirconium diboride did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: All animals were symptom free during the study.
- Gross pathology:
- There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.
Any other information on results incl. tables
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group. Therefore, no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.
Deviations from the study plan:
Due to technical reasons, a relative humidity value (minimum of 26%) outside the expected range of 30-70% was once recorded during the acclimatisation period of the study. However, this minor difference of the environmental parameter was considered not to adversely affect the results or integrity of the study as confirmed by the clinical veterinarian.
During the formulation, the test item was weighed and the formulations were prepared on a weight:volume basis (as (w/v)%) in the Pharmacy, therefore adjustment for specific gravity of the vehicle was not made.
These deviations are considered not to have had an impact on the outcome of the study and interpretation of the results.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the acute oral LD50 value of the test item zirconium diboride was found to be above 2000 mg/kg bw in female Crl:(WI) rats. The study result does not trigger classification under CLP or GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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