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EC number: 215-150-4 | CAS number: 1306-38-3
- 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:
- November 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November - December 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Remarks:
- study performed before the application of the OECD TG 402 but consistent with technical standards (number of animals used, duration of observation period, observations and measurements...)
- GLP compliance:
- no
- Remarks:
- The study was performed before the implementation of GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 180 - 190 g (males) / 150 - 160 g (females)
- Fasting period before study: no
- Housing: individually in 37.5 x 17 x 15 cm cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 5°C
- Humidity: 55 ± 15%
- Air changes: 10 per hr
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From 25 November 1982 To 2 December 1982 - Type of coverage:
- occlusive
- Vehicle:
- other: 10% aqueous gum arabic
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal skin
- % coverage: not specified
- Type of wrap if used: aluminium foil and tape
REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure (removal of dressing): 24 hours
TEST MATERIAL
- Suspension in vehicle applied
- No other details provided
VEHICLE
No details provided - Duration of exposure:
- 24 hours of occlusive dressing
- Doses:
- - Preliminary assay: 1000 and 2000 mg/kg
- Main assay: 0 (vehicle) and 2000 mg/kg - No. of animals per sex per dose:
- - Preliminary assay: 2/sex
- Main assay: 5/sex - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality, clinical signs and local tolerance: just after dosing, 1, 2, 6 hours after dosing and daily for 14 days
Body weight: days 0, 1, 2, 4, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- Not included
- Preliminary study:
- Two groups of 2 rats per sex, clipped on the back 24 hours before, were applied a single cutaneous dose of 1000 or 2000 mg/kg kept under an occlusive dressing (adhesive tape and aluminium foil) for 24 hours, and observed for 14 days. No mortality was observed at either dose level.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the observation period
- Clinical signs:
- other: Slightly reduced activity was observed on day 1 in rats exposed to the test substance. No signs of cutaneous irritation were seen.
- Gross pathology:
- No relevant findings were seen at necropsy on day 14
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dermal LD50 higher than 2000 mg/kg for males and females
- Executive summary:
In an acute dermal toxicity study (Institut Français de Toxicologie report No. 301229), groups of 6 to 7-week old Sprague-Dawley rats (5/sex) were applied a single dermal dose of Cerium Oxide, as a suspension in 10% gum arabic, at doses of 0 (vehicle only) or 2000 mg/kg bw (limit test) under an occlusive dressing applied for 24 hours, and observed for 14 days. Mortality, clinical signs and local tolerance were checked just after application, at 1, 2, 6 hours after dosing, and daily for 14 days. Body weight was recorded on days 0, 1, 2, 4, 7 and 14.
No mortality occurred during the observation period. Slightly reduced activity was observed on day1 in rats exposed to the test substance. No signs of cutaneous irritation were seen. No significant changes in body weight were seen when compared to controls. No relevant findings were seen at necropsy on day 14.
Therefore, the dermal LD50 was higher than 2000 mg/kg for males and females. No classification for acute dermal toxicity is warranted based on the absence of mortality up to a limit dose level, according to UN/EU GHS regulations.
This study is classified as acceptable. Its design is compatible with the OECD 402 guideline requirements for acute dermal toxicity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Remarks:
- study performed before the application of the OECD TG 401 but consistent with technical standards (number of animals used, duration of observation period, observations and measurements...)
- GLP compliance:
- no
- Remarks:
- The study was performed before the implementation of GLP.
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cerium dioxide
- EC Number:
- 215-150-4
- EC Name:
- Cerium dioxide
- Cas Number:
- 1306-38-3
- Molecular formula:
- CeO2
- IUPAC Name:
- cerium dioxide
- Test material form:
- solid: bulk
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
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 180 - 190 g (males) / 150 - 160 g (females)
- Fasting period before study: approximately 18 hours
- Housing: by groups of 5 in 37.5 x 23.5 x 16 cm cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 5°C
- Humidity: 55 ± 15%
- Air changes: 10 per hr
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From 23 November 1982 To 30 November 1982
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 10% aqueous gum arabic
- Details on oral exposure:
- No details provided
- Doses:
- - Preliminary assay: 1000, 2500 and 5000 mg/kg
- Main assay: 0 (vehicle) and 5000 mg/kg - No. of animals per sex per dose:
- - Preliminary assay: 2/sex
- Main assay: 5/sex - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality and clinical signs: just after dosing, 1, 2, 6 hours after dosing and daily for 14 days
Body weight: days 0, 1, 2, 4, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- Not included
Results and discussion
- Preliminary study:
- Three groups of 2 rats per sex, fasted for 18 hours, were given a single oral dose of 1000, 2500 or 5000 mg/kg. During a subsequent 14-day observation period, no mortality was observed at any dose level.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the dosing and observation periods
- Clinical signs:
- other: Whitish discoloration of the feces was observed on day 1
- Gross pathology:
- No relevant findings were seen at necropsy on day 14
- Other findings:
- No other finding
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50 higher than 5000 mg/kg for males and females
- Executive summary:
In an acute oral toxicity study (Institut Français de Toxicologie report No. 301229), groups of fasted 6 to 7-week old Sprague-Dawley rats (5/sex) were given a single oral dose of Cerium Oxide, as a suspension in 10% aqueous gum arabic, at doses of 0 (vehicle only) or 5000 mg/kg bw (limit test) and observed for 14 days. Mortality and clinical signs were checked just after administration, at 1, 2, 6 hours after dosing, and daily for 14 days. Body weight was recorded on days 0, 1, 2, 4, 7 and 14.
No mortality occurred during the dosing and observation periods. Whitish discoloration of the feces was observed on day 1. No significant changes in body weight were seen when compared to controls. No relevant findings were seen at necropsy on day 14.
Therefore, the oral LD50 was higher than 5000 mg/kg for males and females. No classification for acute oral toxicity is warranted based on the absence of mortality up to a limit dose level, according to UN/EU GHS criteria.
This study is classified as acceptable. Its design is compatible with the OECD 401 guideline requirements for acute oral toxicity.
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