Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Apr 2010 - 16 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Principles of method if other than guideline:
- Skin corrosion ability was tested on a human three dimensional epidermal model (EpiDerm (EPI-200)).
- 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
- 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
- Batch: IT-253
- Stability: stable under storage conditions
- Expiry date: 20 Nov 2010
- not soluble in water
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: not applicable
Test system
- Type of coverage:
- other: not applicable, in vitro test
- Preparation of test site:
- other: moistened with water
- Vehicle:
- water
- Controls:
- other: not applicable, in vitro experiment
- Amount / concentration applied:
- Skin tissue was moistened with 25 µL of Milli-Q water.
25 mg test material was applied directly on top of the skin tissue and spread to match the size of the tissue. - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Observation period:
- After exposure cytotoxicity was immediately determined by MTT assay. (Cytotoxicity was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment.)
- Number of animals:
- not applicable, in vitro experiment
- Details on study design:
- TEST MODEL
EpiDerm Skin Model (EPI-200, Lot no.: 12971 kit K), surface 0.6 cm².
The model consisted of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues were cultured on polycarbonate membranes of 10 mm cell culture inserts placed on the surface of cell culture medium.
Source: MatTek Corporation, Ashland MA, U.S.A.
The test was performed on a total of 4 tissues per test substance together with negative and positive controls.
Negative control: Milli-Q water (Millipore Corp., Bedford, Mass., USA)
Positive control: 8.0 N Potassium hydroxide solution (KOH; Merck, Darmstadt, Germany)
Two tissues were used for a 3-minute exposure and two for a 1-hour exposure. After exposure, the tissues were washed with phosphate buffered saline (PBS) to remove residual test substance.
Cell viability was measured immediately after exposure by replacing the cell culture medium (DMEM) with MTT-medium (1 mg/mL) and incubation for 3 hours. After incubation the tissues were washed with PBS and formazan was extracted with 2 mL isopropanol. The amount of formazan was determined spectrophotometrically at 540 nm in triplicate with the Multiskan Spectrum (Thermo Labsystems). Cell viability was calculated for each tissue as percentage of the mean of the negative control tissues.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: mean tissue viability
- Value:
- ca. 95
- Remarks on result:
- other:
- Remarks:
- The relative mean tissue viability obtained after the 3-minute with the test substance compared to the negative control tissues was 95%. (migrated information)
- Irritation / corrosion parameter:
- other: other: mean tissue viability
- Value:
- ca. 101
- Remarks on result:
- other:
- Remarks:
- The relative mean tissue viability obtained after the 1-hour treatments with the test substance compared to the negative control tissues was 101%. (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test substance compared to the negative control tissues was 95% and 101%, respectively. Because the mean relative tissue viability was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment, the test material was considered to be not corrosive.
Any other information on results incl. tables
No direct MTT reduction was found in the pretesting of the test material.
The absolute mean OD 540 (optical density at 540 nm) of the negative control and positive control tissues was within the laboratory historical control data range (collected in 44 observations in the period of January 2007 - December 2009).
Table 1: Mean absorption (OD540) in the in vitro skin corrosion test
|
3-minute application |
1-hour application |
||||
|
A |
B |
Mean |
A |
B |
Mean |
Negative control (water) |
1.711 |
1.634 |
1.673 |
1.718 |
1.748 |
1.733 |
Test material |
1.618 |
1.564 |
1.591 |
1.763 |
1.754 |
1.758 |
Positive control (8.0 N KOH) |
0.107 |
0.111 |
0.109 |
0.101 |
0.100 |
0.101 |
Duplicate exposures are indicated by A and B.
OD540= Optical density at 540 nm.
Table 2: Mean tissue viability in the in vitro skin corrosion test
|
3-minute application (percentage of control) |
1-hour application (percentage of control) |
Negative control (water) |
100 |
100 |
Test material |
95 |
101 |
Positive control (8.0 N KOH) |
7 |
6 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.