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EC number: 941-788-4 | 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:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE Experimental Toxicology and Ecology 67056 Ludwigshafen, Germany
Test material
- Reference substance name:
- Calcination product of titanium dioxide, tin monoxide, zinc oxide and dihydrogen wolframate
- EC Number:
- 941-788-4
- Molecular formula:
- Ti 1 Sn 0,6 Zn 0,5 W 0,15 O 4
- IUPAC Name:
- Calcination product of titanium dioxide, tin monoxide, zinc oxide and dihydrogen wolframate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Solid / red
stored at room temperature
The test substance was homogeneous by visual inspection.
The test item is not surface-treated or otherwise coated.
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- not applicable
The EpiOcularTM model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinozytes used to model the human corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and are commercially available as kits (EpiOcular™ 200), containing 24 tissues on shipping agarose.
To assess the ability of the test material to directly reduce MTT a pretest was performed.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes (tissue incubations for positive and negative controls included)
- Amount / concentration applied:
- 0.05 mL
- Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18h
- Number of animals or in vitro replicates:
- Two tissue samples were used per group.
- Details on study design:
- Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The
quotient of the values indicates the relative tissue viability.
As the substance showed a potency for direct reduction of MTT by the test substance, the OD570 values were also measured in freeze-killed control tissues (KC) to calculate the mean OD570 of the test substance treated tissues (mean OD570 KC corrected). Since killed tissue might still have a residual enzyme activity that is able to produce some formazan net OD570 KC is calculated by subtracting the OD570 KC of the NC from the OD570 KC of the test substance. In case the net OD570 KC is greater than zero it is subtracted from the respective mean OD570 to result in the
mean OD570 KC corrected. The mean OD570 KC corrected represents the formazan production linked to the tissue viability and therefore indicates the cytotoxic potency of the test substance.
The color of a test substance may interfere with the color density produced by metabolic capacity of the tissue and would falsify the test results when residues of the test substance remain on the tissues after washing and are extracted by the isopropanol.
Due to the pink to red color of the test substance a pretest was performed as follows: the test substance was applied to killed cell tissues, incubated and removed by washing. Thereafter extraction in isopropanol was performed and the OD570 of the extract was determined spectrophotometrically. Based on the pretest it was judged that no color control (CC) was necessary (details are available with the raw data).
Results and discussion
In vitro
Results
- Irritation parameter:
- other: viability (%)
- Run / experiment:
- mean of both tissues
- Value:
- 85.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: none
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
In vivo
- Other effects:
- Slight red discoloration of the test-substance treated tissues and slight compound residues were observed after the washing procedure.
Any other information on results incl. tables
Table 1: Results
tissue 1 | tissue 2 | mean | Inter-tissue variability (%) | ||
Negative control (water) | mean OD570 | 1.806 | 1.784 | 1.795 | |
viability (% of NC) | 100.6 | 99.4 | 100 | 1.2 | |
test substance | mean OD570 | 1.535 | 1.525 | 1.53 | |
viability (% of NC) | 85.5 | 85 | 85.3 | 0.6 | |
Positive control (methyl acetate) | mean OD570 | 0.432 | 0.486 | 0.46 | |
viability (% of NC) | 24.3 | 27.1 | 25.6 | 2.8 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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