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Diss Factsheets
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EC number: 215-145-7 | CAS number: 1306-06-5
- 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 26.Oct. 2015 to 29.Jan. 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)
- Version / remarks:
- EpiOcular(TM) kit
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, D-55116 Mainz, Germany
Test material
- Reference substance name:
- Hydroxylapatite (Ca5(OH)(PO4)3)
- EC Number:
- 215-145-7
- EC Name:
- Hydroxylapatite (Ca5(OH)(PO4)3)
- Cas Number:
- 1306-06-5
- Molecular formula:
- Ca5HO13P3
- IUPAC Name:
- pentacalcium hydroxide triphosphate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Commercially available EpiOcular(TM) kit (OCL-212-EIT, batch no. 21580), procured by MatTek In Vitro Life Science Laboratories, Mylnské Nivy 73, 82105 Bratislava, Slovakia.
The EpiOcular(TM) tissue consist of normal, human-derived keratinocytes cultured to form a stratified epithelium similar to the human cornea. These cells are not transformed or transfected with genes to induce an extenden life span. The tissues are cultured in specially prepared cell culture inserts with a porous membrane through which nutrients can pass. The surface is 0.6cm².
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Tissue 1: 49.4 mg/plate
Tissue 2: 46.0 mg/plate - Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18h at 37+/-1°C, 5+/-1% CO2 and 80-100% relative humidity
- Number of animals or in vitro replicates:
- 2 x 2
- Details on study design:
- In a pre-Test no direct reduction of MTT by the test substance or change of colour by test substance or medium was found. Before use all cell cultures were inspected for viability and the presence of air bubbles between agarose gel and insert.
After overnight incubation, pre-wetting and a further incubation for 30 minutes, the test substance and controls (50µl) were applied. The exposure time was controlled by a stop watch. The tissues were removed, rinsed immediately and transfered to new medium for pre-incubation. Then the tissues were incubated in freshly prepared MTT-reagent for 180 minutes. The living cells reduce MTT to a formazan salt, that is extracted by isopropanol and quatified by a plate spectral photometer at 570nm. Then the viability of the cells is calculated.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: viability (%) by absorbance values
- Run / experiment:
- tissue 1: 97.7% viability, tissue 2: 100.1% viability, mean: 98.9% viability
- Value:
- 1.566
- Vehicle controls validity:
- valid
- 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:
- The threshold for eye irritation potential in this test is = 60% viability. The result in this experimental study showed 98.9% viability of the cells. Therefore the test substance is considered to be not irritant to eyes in the EpiOcular(TM)-Test.
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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