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Diss Factsheets
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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- November 1982 - February 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD TG 404-compliant study
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:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Roucher, Couhé France - EGAV, Passais-la-Conception France - Elevage Scientifique des Dombes, Châtillon-sur-Chalaronne France - Gwen Meur, Trégonneau France
- Age at study initiation: not specified
- Weight at study initiation: 2.5 kg +/- 200 g
- Housing: individual polystyrene cages (54 x 36 x 31.5 cm)
- Diet: 150 g pelleted diet/animal/day
- Water: ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12 (7.30 am - 7.30 pm)
IN-LIFE DATES: 23 November 1982 (application)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistening with 0.1 mL water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm² skin surface
- Type of wrap: semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- Erythema and Eschar Formation:
No erythema -> 0
Very slight erythema (barely perceptible) ->1
Well defined erythema -> 2
Moderate to severe erythema -> 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema -> 4
- Oedema Formation:
No oedema -> 0
Very slight oedema (barely perceptible) -> 1
Slight oedema (edges of area well defined by definite raising) -> 2
Moderate oedema (raised approximately 1 mm) -> 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) -> 4
- Primary Dermal Irritation Index = (Sum of individual Erythema scores + Sum of individual Edema scores) / 12
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Summary table of individual irritation scores:
Rabbit number |
445 |
446 |
447 |
Total |
Mean |
|
Erythema score |
||||||
Timepoints (h) |
1 |
0 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
|
Edema score |
||||||
Timepoints (h) |
1 |
0 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC or UN/EU GHS
- Conclusions:
- Cerium dioxide is not considered to be a skin irritant.
- Executive summary:
In a primary dermal irritation study (Institut Français de Toxicologie report No. 302314), 3 male New Zealand White rabbits were dermally exposed to 0.5 g of Cerium dioxide moistened with 0.1 mL water applied on a ~6 cm² skin area maintained under semi-occlusive dressing for 4 hours. Animals then were observed for up to 72 hours. Irritation was scored 1, 24, 48 and 72 h after removal of the dressing by calculating dermal irritation scores, based on the grading of cutaneous erythema and edema.
No signs of cutaneous erythema or edema were observed. The dermal irritation scores were equal to 0.
The test substance was therefore considered as non-irritant to the skin. No classification for skin irritation is warranted based on the absence of cutaneous reactions following a 4 -hour exposure, according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
This study is classified as acceptable. It satisfies the OECD 404 guideline requirements for acute dermal irritation or corrosion.
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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