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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: - | 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:
- From February 2022 to March 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
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)
Test material
- Reference substance name:
- Anatase, rutile, disodium hexatitanate and sodium tetratitanate
- IUPAC Name:
- Anatase, rutile, disodium hexatitanate and sodium tetratitanate
Constituent 1
- Specific details on test material used for the study:
- Batch No.: OP.1501019
Test animals / tissue source
- Species:
- human
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Amount of sample tested in two replicates: Rep 1 = 50.3 mg, Rep.2 = 50.9 mg
- Duration of treatment / exposure:
- Tissues were exposed for 6 hours to the raw substance by direct contact.
- Duration of post- treatment incubation (in vitro):
- The exposure is followed by washing with DPBS and an 18-hour post-incubation. and an incubation with MTT medium for 3 hours.
- Number of animals or in vitro replicates:
- Two replicates were tested
- Details on study design:
- In vitro "EpiOcular Eye Irritation Test" was used:
the tissues are conditioned by pre-incubation (1 hour or overnight) to release compounds related to transport stress and debris. Then they undergo a further pre-incubation phase for 18 hours. After the pre-incubation phase, the tissues are transferred to a fresh culture medium and exposed for 6 hours to the raw substance by direct contact. The exposure is followed by washing with DPBS and an 18-hour post-incubation. Two tissues are used respectively for the sample, for the negative control (C-) and for the positive control (C+). After exposure, the tissues are rinsed and dried, the test medium is replaced with the MTT medium. After 3 hours of incubation, the tissues are washed with DPBS and dried, then the blue formazan salts are extracted with isopropanol. The optical density (OD) of the formazan extract is determined by a spectrophotometer set at λ = 570 nm and the cell viability is calculated for each tissue as the percentage of the mean of the negative control tissues. The potential eye irritation caused by the test substance is determined according to the residual cell viability obtained after exposure.
Results and discussion
In vitro
Results
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- The result is an average of two measurements derived by two replicates.
- Value:
- ca. 94.9
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under test conditions, the test item was not irritant to eyes.
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.
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