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Diss Factsheets
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EC number: 943-098-9 | 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:
- 27 July 2016 - 29 July 2016
- Reliability:
- 1 (reliable without restriction)
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tin dioxide
- EC Number:
- 242-159-0
- EC Name:
- Tin dioxide
- Cas Number:
- 18282-10-5
- Molecular formula:
- O2Sn
- IUPAC Name:
- Tin Dioxide
- Test material form:
- solid: nanoform
- Details on test material:
- Sample Reference: W0167
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The EpiOcular™ tissues
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Approximately 50 mg of the test item (83.3 mg/cm2 according to guideline)
- Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- duplicate
- Details on study design:
- .
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % formazan production compared to negative control
- Run / experiment:
- 2 tissues
- Value:
- ca. 26.5
- Negative controls validity:
- valid
- Remarks:
- 0.8 - 2.5 %
- Positive controls validity:
- valid
- Remarks:
- 32.6 %
- Other effects / acceptance of results:
- The negative control OD is > 0.8 and < 2.5 (1.387 and 1.452).
The mean relative viability of the positive control is below 50% of the negative control viability (32.6%).
The difference of viability between the two relating tissues of a single item is < 20% (values between 0.9% to 2.8%) in the same run (for positive and negative control tissues and tissues of single test items). This did not apply to the killed controls (items and negative killed control) and the colorant controls which were calculated as percent values related to the viability of the relating negative control.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Irritating effects were observed following incubation with TUBALL®. Compared with the value of the negative control the relative mean absorption value corresponding to the viability of the tissues decreased below 60% (26.5%).
In conclusion, it can be stated that in this study and under the experimental conditions reported, TUBALL® possesses an eye irritating potential. - Executive summary:
This in vitro study was performed to assess the eye irritation potential of TUBALL® by means of the Human Cornea Model Test.
Because of the intense black colour of the test item additional tests with freeze killed tissues and with viable tissues were performed.
About 50 mg of the test item and each 50 µL of the controls, respectively, were applied to each of duplicate EpiOcular™ tissue for 6 hours.
Treatment with the positive control induced a decrease in the mean relative absorbance compared with the negative control to 32.6%, thus the validity of the test system is ensured.
The acceptance criteria were met.
Relevant irritating effects were observed following 6 hours incubation with TUBALL®. The mean relative absorption value of the tissues corresponding to the cornea viability decreased to 26.5% compared with the value of the negative control (threshold for irritancy: ≤ 60%).
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