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EC number: 910-388-1 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Apr 2010 - 14 Apr 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (07 Sep 2009)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of silicon dioxide and zirconium dioxide
- EC Number:
- 910-388-1
- Molecular formula:
- not applicable (multi-constituent substance)
- IUPAC Name:
- Reaction mass of silicon dioxide and zirconium dioxide
- Details on test material:
- - Name of test material (as cited in study report): Silica-Zirkonia Filler
- Physical state: White powder
- Batch: IT-253
- Analytical purity of components: 72.4% silicon dioxide (CAS No. 7631-86-9) and 26.0% zirconium dioxide (CAS No. 1314-23-4) and a not stated percentage of disodium oxide (CAS No. 1313-59-3)
- Storage: at room temperature in the dark
- Stability: stable under storage conditions
- Expiry date: 20 Nov 2010
- not soluble in water
Constituent 1
Test animals / tissue source
- Species:
- other: bovine eye
- Strain:
- not specified
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 750 µL of a 20% (w/w) suspension (in saline from Merck, Germany) of the test material, the vehicle control or the positive control were introduced onto the epithelium of the cornea and uniformously distributed over the entire cornea.
Negative control: physiological saline (Merck, Germany)
Positive control: 20% (w/w) Imidazole (Merck Schuchardt DHG, Germany, CAS No. 288-32-4) solution prepared in physiological saline - Duration of treatment / exposure:
- Corneas were incubated in a horizontal position for 240 +/- 10 min at 32 ºC.
- Observation period (in vivo):
- Measurement directly after incubation
- Number of animals or in vitro replicates:
- Not applicable, in vitro testing in triplicate
- Details on study design:
- Bovine eyes were used as soon as possible after slaughter on the same day (slaughterhouse Vitelco, 's Hertogenbosch, The Netherlands). Eyes were transported in physiological saline. Only intact eyes were used. The corneas were isolated and stored at 32 ºC in cell culture medium (cMEM). Each isolated cornea was mounted in a corneal holder of MC2 (Clermont, France) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM and incubated for at least 1 hour at 32 ºC. Thereafter the initial opacity of each cornea was measured with an opacitometer (OP-KIT, MC2, Clermont, France) and recorded. Corneas with an initial opacity > 3 were not used.
After the incubation the solutions were removed and the epithelium was washed at least three times with cMEM. The anterior and the posterior compartement were refilled with fresh cMEM and an opacity determination was performed without any further incubation. After the completion of the incubation period each cornea were inspected visually for dissimilar opacity patterns and the opacity determination was performed. Permeability of the cornea was evaluated using 5 mg/mL sodium fluorescein in the anterior compartment. After 90 minutes incubation time the amount of fluorescein that crosses into the posterior compartment was measured by UV/VIS spectrophotomerty as optical density at 490 nm (OD490).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: mean in vitro irritation score (IVIS)
- Basis:
- other:
- Time point:
- other: negative control (physiol. saline)
- Score:
- 0
- Remarks on result:
- other: mean opacity value + (15 x mean OD490 value)
- Irritation parameter:
- other: mean in vitro irritation score
- Basis:
- other:
- Time point:
- other: test substance (20% solution in physiol. saline)
- Score:
- 2
- Remarks on result:
- other: mean opacity value + (15 x mean OD490 value)
- Irritation parameter:
- other: mean in vitro irritation score
- Basis:
- other:
- Time point:
- other: positive control (20% imidazole)
- Score:
- 106
- Remarks on result:
- other: mean opacity value + (15 x mean OD490 value)
- Irritant / corrosive response data:
- The treated corneas showed opacity values ranging from 1 to 3 and permeability values ranging from 0 to 0.009. The corneas were clear after the 240 minutes exposure. Hence, the in vitro irritancy scores ranged from 1 to 3 after 240 minutes of treatment.
The laboratories historical control values collected in a period of July 2008 to October 2009 ranged from 0 to 1 for opacity, from -0.007 to 0.009 for permeability and from -0.1 to 1.1 for In vitro Irritancy Score. The values for the test material (tested as 20% solution) were slightly outside the historical control range.
Any other information on results incl. tables
Table 1: Summary of opacity, permeability and in vitro scores
|
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score1,2 |
Negative control (physiol. saline) |
0 |
0.000 |
0 |
Test material (20% (w/w) suspension in physiol. saline |
2 |
0.003 |
2 |
Positive control (20% (w/w) Imidazole in physiol. saline)
|
76 |
1.998 |
106 |
1Calculated using the negative control mean opacity and mean permeability values.
2In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490value).
Applicant's summary and conclusion
- Interpretation of results:
- other: Since the mean in vitro irritancy score for the test substance was below 55.1 after 240 minutes treatment, the test substance is considered to be neither corrosive nor severely irritating.
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- According to OECD Guideline 437, the tested substance was neither corrosive nor severely irritating, as the IVIS was found to be < 55.1.
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