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EC number: 236-007-2 | CAS number: 13093-17-9
- 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:
- Between 6 November 2012 and 6 December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study performed according to OECD Guideline 420 and EU Method B.1 bis.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Cerium tetranitrate
- EC Number:
- 236-007-2
- EC Name:
- Cerium tetranitrate
- Cas Number:
- 13093-17-9
- Molecular formula:
- Ce.4HNO3
- IUPAC Name:
- cerium tetranitrate
- Test material form:
- other: liquid substance in its solvent (i.e. water), as it cannot be obtained without it
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: range: 149 - 159 grams
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70% respectively
- Air changes (per hr): at least fifteen air changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- VEHICLE
The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration. - Doses:
- Following a sighting test at dose levels of 338 mg/kg and 2248 mg/kg (equivalent to 300 and 2000 mg/kg active ingredient/kg bodyweight, respectively), a further group of four fasted females was given a single oral dose of test item, as a solution in distilled water, at a dose level of 2248 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).
- No. of animals per sex per dose:
- Fixed dose method:
In the absence of data regarding the toxicity of the test item, 338 mg/kg (equivalent to 300 mg active ingredient/kg bodyweight) was chosen as the starting dose using one animal.
In the absence of toxicity at a dose level of 338 mg/kg, an additional animal was treated at a dose level of 2248 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight).
In the absence of toxicity at a dose level of 2248 mg/kg, an additional group of four animals was treated at a dose level of 2248 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight). - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were made 1/2, 1, 2, and 4 hours after dosing and then daily for fourteen days.
Morbidity and mortality checks were made twice daily.
Individual bodyweights were recorded on day 0 (the day of dosing) and on days 7 and 14.
- Necropsy of survivors performed: yes: at the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: LD50 > 2248 mg/kg bodyweight
- Mortality:
- At 338 mg/kg (equivalent to 300 mg active ingredient/kg bodyweight) and 2248 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight) there was no mortality.
- Clinical signs:
- other: At 338 mg/kg (equivalent to 300 mg active ingredient/kg bodyweight) no signs of systemic toxicity were noted during the observation period (1 animal). At 2248 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight) no signs of systemic toxicity were
- Gross pathology:
- At 338 mg/kg (equivalent to 300 mg active ingredient/kg bodyweight) and 2248 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight) no abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in female Wistar strain rat was estimated to be greater than 2248 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/20008, relating to the Classification, Labeling and Packacing of Dangerous Substances.
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