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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 11. Nov. 2015 to 01.Dec. 2015
- 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Mainzer Str. 80, D-65189 Wiesbaden, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- females (non-pregnant and nulliparous), healthy (checked 5 days prior to the experiment)
environment: temperature 22+/-2°C, trel. humidity. approx. 45-65%, artificial light from 6.00a.m. - 6.00p.m.
Cage with wire mesh top, granulated soft bedding, certified rodent diet and tap water ad libitum
pre-test. 2 animals identified by cage number, test: 16 animals identified by tail tags. All animals belonging to the same experimental group were kept together in one cage.
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Remarks:
- 25% suspension (highest level achieved)
- Concentration:
- 25µl for the dorsal surface of each ear on 3 consecutive days
pre-test: 10% and 25%
test: 5%, 10%, 25%, negative control: vehicle, - No. of animals per dose:
- 4
- Details on study design:
- clinical signs checked dayly,
body weights, ear thickness and ear weights were reported - Statistics:
- no, poole lymph node assay
Results and discussion
- Positive control results:
- historical data from Oct. 2015 (with a-hexyl cinnamaldehyde in acetone/olive oil (4+1, v/v) reported
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Remarks:
- EC3 values not calculated because all Si under 3
- Value:
- > 2
- Variability:
- 1.43 - 1.26 - 1.71
- Test group / Remarks:
- negative control group: SI = 1, positive control group (hist.): SI = 17.56 (25%)
- Remarks on result:
- other: no skin irritation
- Cellular proliferation data / Observations:
- no clinical signs (systemic or local on the ears) or uncommon changes in body weights were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not a skin sensitizer under the conditions of this experiment.
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.