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EC number: 909-701-4 | 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- November - December 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to OECD TG 402-compliant study, using a main constituent of the reaction mass for a read-across purpose
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Remarks:
- / Study performed before the application of the OECD test guideline 402 but consistent with technical standards (number of animals used, duration of observation period, observations and measurements...)
- GLP compliance:
- no
- 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
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: 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 (°C): 22 +/- 5
- Humidity (%): 55 +/- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From: 25 November 1982 To: 2 December 1982
Administration / exposure
- 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
Results and discussion
- 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.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- 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
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Annex VI Directive 67/548/EEC or UN/EU GHS
- 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 the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
This study is classified as acceptable. Its design is compatible with the OECD 402 guideline requirements for acute dermal toxicity.
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