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EC number: 909-709-8 | CAS number: -
- 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:
- from 16-OCT-1995 to 08-MAR-1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of cerium dioxide and zirconium dioxide
- EC Number:
- 909-709-8
- Molecular formula:
- (Ce, Zr)O2
- IUPAC Name:
- Reaction mass of cerium dioxide and zirconium dioxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Poudre catalytique à base d'oxyde de cérium et d'oxyde de zirconium (OBD 30)
- Substance type: multi-constituent substance
- Physical state: yellow powder
- Further information on test material confidential
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, 69210 L'Arbresle, France
- Age at study initiation: 6 weeks old
- Weight at study initiation: 173 +/- 4 g for the males, 145 +/- 5 g for the females
- Fasting period before study: 18 hours, they were then given food 4 hours after treatment
- Housing: The animals were housed in groups of 4 to 7 animals of the same sex in polycarbonate cages (48x27x20 cm) during the acclimatisation period and groups of 5 animals of the same sex during the study.
- Diet (e.g. ad libitum): free access to AO4 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France) except in fasting period
- Water (e.g. ad libitum): drinking water filtered by a Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): about 12 cycles/hour of filtered, non recycled air
- Photoperiod (hrs dark / hrs light): 12hr/12hr
IN-LIFE DATES: From: 14 nov 1995 To: 28 nov 1995
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous solution of methylcellulose at 0.5%
- Details on oral exposure:
- VEHICLE
The vehicle used was an aqueous solution of methylcellulose at 0.5%:
- water for injections, batch N° 5842 (Laboratoire Fresenius, 92316 Sèvres, France)
- methylcellulose, batch N° 15H0241 (Sigma, 38297 Saint-Quentin-Fallavier, France)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION:
On the day of the treatment, the test substance was ground using a mortar and pestle, then was suspended in the vehicle. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- DETAILS ON STUDY DESIGN
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed frequently after administration of the test substance and at least once a day for clinical signs.
- Frequency of weighing: Animals were weighed just before administration of the test substance and then on days 1, 8 and 15.
- Necropsy of survivors performed: yes on day 15
- Other examinations performed: macroscopic examination at necropsy (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities) - Statistics:
- no data
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occurred during the observation period.
- Clinical signs:
- other: No clinical signs were observed during the study.
- Gross pathology:
- The macroscopic examination of the main organs of the animals sacrificed at the end of the study revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the oral LD50 of the reaction mass of cerium dioxide and zirconium dioxide was higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose.
- Executive summary:
The reaction mass of cerium dioxide and zirconium dioxide has been tested for acute oral toxicity in Sprague Dawley rats, according to OECD guideline No. 401 and in compliance with Good Laboratory Practices. The test article, suspended in 0.5% aqueous methylcellulose, was administered as a single dose of 2000 mg/kg to a group of 5 males and 5 females, at a dosing volume of 10 mL/kg. Following treatment, mortality, clinical signs and body weight were recorded for a two-week observation period. On day 15, the animals were euthanatised and necropsied.
No deaths occurred and no clinical signs were observed in this study. Body weight gain was not affected by treatment. At necropsy, a macroscopic examination revealed no abnormality .
As the minimal lethal dose was found to be higher than 2000 mg/kg, the reaction mass of cerium dioxide and zirconium dioxide is not classified according to the criteria of EU-CLP Regulation 1272/2008.
This acute oral study is classified as acceptable. It does satisfy the guideline requirements for an acute oral study (OECD 401) in rats.
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