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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
Additional ecotoxological information
Administrative data
- Endpoint:
- additional ecotoxicological information
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Exposure of primary trout hepatocytes to nano-CeO2 or bulk CeO2 suspensions
- Cytotoxicity: Lactate dehydrogenase (LDH) assay - GLP compliance:
- not specified
- Type of study / information:
- Cytotoxicity of nanometric cerium dioxide (nano-CeO2) and micrometric CeO2 (bulk) in primary trout hepatocytes
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: nanoform
- Details on test material:
- - Name of test material: Nanometric cerium oxide (nano-CeO2)
- Supplier: None (in-house synthesis using wet chemistry method)
- Substance type: Monoconstituent substance
- Substance form: Nanoparticulate substance
- Primary particle size (SEM, XRD): Average diameter of 16-22 nm (data from De Marzi et al., 2013)
- Particle size distribution (SEM): Presence of ~40-nm clusters (data from De Marzi et al., 2013)
- Stability: Slight agglomeration/aggregation based on SEM observations (data from De Marzi et al., 2013)
- Specific surface area: No data available
- Surface charge (DLS): Zeta potential of -46.2 mV in water at pH 7.4 (data from De Marzi et al., 2013)
- Isoelectric point: No data available
- Shape (SEM): No data available
- Crystallinity (XRD): No data available
- Analytical purity / impurities: No data available
- Number density of nano-CeO2 in the suspension: No data available
- Cerium content in nano-CeO2 suspension: No data available
- Solubility: No data available
- Oxidation degree: No data available
- Surface properties (SEM, FTIR): Smoothed and non-porous surface; detection of Ce-O bond, O-H bond in water adsorbed on the sample surface and residual surfactant (CH2) (data from De Marzi et al., 2013)
- Lot/batch No.: No data available
- Expiration date of the lot/batch: No data available
Further explanations on the physico-chemical characterisation of CeO2 nanoparticles are presented below in "any other information on materials and methods incl. tables".
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Nanometric cerium dioxide (nano-CeO2)
- Supplier: Sigma-Aldrich
- Substance type: Monoconstituent substance
- Substance form: Nanoparticulate substance / nanomaterial in suspension
- Primary particle size (XRD): 11.5 ± 0.2 nm (< 25 nm according to the supplier)
- Particle size distribution (AFM, DLS, HRTEM): From 14.9 to 411 nm in Caco-2 medium (see in Table 1 below)
- Stability: Aggregation based on particle size distribution
- Specific surface area (BET): 60 m²/g
- Surface charge (electrophoretic mobility): Zeta potential of -7 mV in Caco-2 cell medium
- Isoelectric point: No data available
- Shape: No data available
- Crystallinity: No data available
- Analytical purity / impurities: No impurities detected for nano-CeO2 powder
- Number density of nano-CeO2 in the suspension: No data available
- Cerium content in nano-CeO2 suspension: No data available
- Solubility: Essentially insoluble in solution
- Oxidation degree (EELS): 62% Ce(III) and 38% Ce(IV) as a raw powder; 100% Ce(IV) in Caco-2 cell medium
- Surface properties: No data available
- Lot/batch No.: No data available
- Expiration date of the lot/batch: no data available
Futher explanations on the physico-chemical characterisation of CeO2 nanoparticles are presented below in "any other information on materials and methods incl. tables".
A non-nano (bulk) CeO2 was also tested in this study:
- Supplier: Sigma
- Substance type: Monoconstituent substance
- Substance form: Microparticulate substance / bulk material in suspension
- Primary particle size (XRD): > 1000 nm (< 5 µm according to the supplier)
- Particle size distribution (AFM, DLS, HRTEM): From 62.1 to 1666 nm in Caco-2 medium (see in Table 1 below)
- Stability: Aggregation based on particle size distribution
- Specific surface area (BET): 0.4 m²/g
- Surface charge(zeta potentiometry): Zeta potential of -5 mV in Caco-2 cell medium
- Isoelectric point: No data available
- Shape: No data available
- Crystallinity: No data available
- Analytical purity / impurities: No data available
- Number density of nano-CeO2 in the suspension: No data available
- Cerium content in nano-CeO2 suspension: No data available
- Solubility (UF-ICP-MS): Essentially insoluble
- Oxidation degree (EELS): Mainly Ce(IV) with a very thin layer of Ce(III) on the surface (1 to 10 nm) as a raw powder; no data in Caco-2 cell medium
- Surface properties: No data available
- Lot/batch No.: No data available
- Expiration date of the lot/batch: No data available
Results and discussion
Any other information on results incl. tables
- CYTOTOXICTY ASSESSMENT:
Treatment of primary trout hepatocytes with CeO2 particles of either size for 24 h did not cause significant LDH release up to and including the concentration of 1000 mg/mL. Thus, this result demonstrated that CeO2 induced no alteration of membrane integrity and consequently no cytotoxicity, despite evidence of direct spatial contact and even uptake.
Applicant's summary and conclusion
- Conclusions:
- Nano-CeO2 and bulk CeO2 did not cause cytotoxicity in the primary fish hepatocytes.
- Executive summary:
Gaiser BK et al. (2012) performed an in vitro test to assess the cytotoxicity of nanometric cerium dioxide (nano-CeO2) and micrometric CeO2 (bulk) to primary trout hepatocytes.
Primary trout hepatocytes were cultured in Sigma Medium 199 supplemented with 344 mg/L NaHCO3, 500 mg/L CaCl2 x 2H2O, 10 % foetal calf serum (FCS), 834 mg/L N-(2-Hydroxyethyl)piperazine-N’-(2 -ethane sulfonic acid), 344 mg/L NaHCO3, 500 g/L CaCl2 and 100 U/mL penicillin/0.1 mg/mL streptomycin, and incubated at 12°C. For the purpose of the experiment, hepatocytes were seeded at 100 000 cells/well in a 96-well plate, incubated overnight, and treated with particles concentrations ranging from 0 to 1000 mg/L for 24 h in the appropriate medium. Plates were centrifuged at 25 g to remove cell debris and particles, and cytotoxicity was measured immediately as supernatant lactate dehydrogenase content. Indeed, the release of this molecule is indicative of the alteration of membrane integrity.
In parallel, nano-CeO2 and bulk CeO2 were characterised for several physico-chemical parameters. However, the results obtained in cell culture medium of primary trout hepatocytes are not provided in the publication as the authors indicated that these data were not obviously different from those obtained on another cell medium tested in the publication:
Parameters
Results
Methods
Nano-CeO2
Bulk CeO2
Primary particle size (raw powder)
< 25 nm
11.5 ± 0.2 nm
< 5 µm
> 1000 nm
Supplier’s data
XRD
Particle size distribution
in Caco-2 cell medium supplemented with 10% FCS
14.9 ± 7.4 nm
411 ± 33 nm
14.9 ± 6.3 nm
62.1 ± 48.4 nm
1666 ± 1554 nm
387 ± 82 nm
AFM
DLS
HRTEM
in Daphnia magna medium
3958 ± 1955 nm
2729 ± 1858 nm
DLS
Specific surface area (raw powder)
60 m²/g
0.4 m²/g
BET
Surface charge
in Caco-2 cell medium supplemented with 10% FCS
Zeta potential of -7 mV
-5 mV
Zeta potentiometry charge
in Daphnia magna medium
Zeta potential of -10 mV
-4 mV
Zeta potentiometry charge
Dissolution
Essentially insoluble in Caco-2 cell and D. magna media
Essentially insoluble in Caco-2 cell and D. magna media
UF-ICP-MS
Surface speciation / oxidation degree
raw powder
62% Ce(III) and 38%Ce(IV)
Mainly Ce(IV) with a very thin layer of Ce(III) on the surface (1 to 10 nm)
EELS / XPS
in Caco-2 cell medium
100% Ce(IV)
No data
EDX / XPS
Purity (raw powder)
No impurities detected
No data
EDX / XPS
Treatment of primary trout hepatocytes with CeO2 of either size for 24 h did not cause significant release of lactate dehydrogenase up to and including the concentration of 1000 mg/L; thus implying no alteration of membrane integrity and consequently no cytotoxicity.
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