Registration Dossier
Registration Dossier
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EC number: 215-145-7 | CAS number: 1306-06-5
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-03-03 to 2016-03-10
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
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
- Specific details on test material used for the study:
- Name Hydroxyapatite
Batch no. D25X014
CAS 1306-06-5
EINECS 215-145-7
Appearance white powder
Composition >99% Hydroxylapatite
Purity >99%
Homogeneity homogeneous
Stability stable at room temperature
Water solubility poorly water soluble, but a transformation and dissolution
of ions included is possible
Volatility not volatile
Expiry date Aug. 2018
Storage Room Temperature (20 ± 5°C), keep away from humidity
Results and discussion
Water solubilityopen allclose all
- Key result
- Water solubility:
- ca. 36.23 mg/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 50 g/L
- Temp.:
- 20 °C
- Remarks on result:
- other: concentration of calcium in water
- Key result
- Water solubility:
- ca. 0.296 mg/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 50 g/L
- Temp.:
- 20 °C
- Remarks on result:
- other: concentration of phosphorus in water
- Details on results:
- At the plateau, the concentration of Calcium in water had reached
36.23 ± 0.36 mg/L Ca at 20.0 ± 0.5 °C
= 3.623 ± 0.036 * 10-2 kg/m3 (SI units)
(mean value ± standard deviation of six individual vessels 1A-1C and 2-4)
The concentration of Phosphorous in water had reached
0.296 ± 0.018 mg/L P at 20.0 ± 0.5 °C
= 0.296 ± 0.018 * 10-3 kg/m3 (SI units)
(mean value ± standard deviation of four individual vessels 1A-1C and 4)
A partial solubility of the test item was observed due to the release of different ions from the test item (0.07 % Ca and 0.0006% P, calculated from the nominal load of 50 g/L)
No Tyndall effect (i.e. a laser beam was not scattered when transmitted through the liquid) could be observed indicating that no colloidal dispersed particles are present.
The measured aluminium and sulphur concentrations showed good correspondence in all flasks. Therefore, all replicates were used in the calculation of the mean.
Applicant's summary and conclusion
- Conclusions:
- Test item is poorly soluble: Calcium reached 36 mg/L and phosphorus 0.30 mg/L (at 20°C)
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