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Diss Factsheets
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EC number: 231-166-4 | CAS number: 7440-58-6
- 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 vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted without any deviations to the guideline, but quoted with 2 because of the read across
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hafnium dioxide
- EC Number:
- 235-013-2
- EC Name:
- Hafnium dioxide
- IUPAC Name:
- hafnium dioxide
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- other: in vitro test using human skin model
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 10 mg (26.3 mg/cm²) of the crushed powder were applied to the epidermis surface
VEHICLE: 5µL distilled water were used as vehicle - Details on study design:
- The study was carried out with the Episkin SM tissues provided as a kit.
The tissues were exposed to the substance during 15 minutes and then post incubated 42h. The viability was determined by optical densimetry at 550nm to check the colouring potential of the substance (= reduction of MTT).
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: MTT reduction showed by optical density
- Value:
- 98.4
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean tissue viability. Reversibility: other: not applicable. (migrated information)
In vivo
- Irritant / corrosive response data:
- The mean relative tissues viability is ≥ 50% and then substance showed no irritant effects.
Any other information on results incl. tables
table of results:
|
Negative control : PBS |
Positive control : SDS 5% |
HfO2 |
||||||
Blank corrected mean OD at 550nm |
0.847 |
0.883 |
0.859 |
0.049 |
0.055 |
0.070 |
0.892 |
0.816 |
0.838 |
Blank corrected mean OD of the 3 replicates |
0.863 |
0.058 |
0.849 |
||||||
Standard deviation OD |
0.02 |
0.01 |
0.04 |
||||||
Relative tissue viabilities % |
98.1 |
102.4 |
99.5 |
5.7 |
6.3 |
8.1 |
103.4 |
94.6 |
97.1 |
Mean tissue viabilities % |
100 |
6.7 |
98.4 |
||||||
Standard deviation tissue viabilities % |
2.2 |
1.3 |
4.6 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: UN GHS and EU CLP
- Executive summary:
The potential of the test item to induce skin irritation was tested by using the three dimensional human skin model Episkin-SM. HfO2 was applied with water topically to the tissue for 15 minutes followed by a 42h post incubation period and immediate determination of cytotoxic effects via MTT reduction assay.
Irritant potential was predicted from the relative mean tissue viabilities obtained compared to the negative control treated with PBS.
HfO2 showed no irritant effects as the mean relative tissue viability was ≥ 50% (98.4%).
The controls confirmed the validity of the study:
- the mean optical density of the six blank values was < 0.1
- the mean absolute OD of the three negative control tissues was ≥0.6 and ≤ 1.5
- the mean relative tissue viability of the positive control (SDS 5%) was ≤ 40% (6.7%)
- the maximum standard deviation of viability of replicate tissues of all dose groups was ≤ 18% (1.3 - 4.5%).
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