Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 211-560-2 | CAS number: 665-66-7
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Principles of method if other than guideline:
- Laser diffraction according to ISO 13320-1, with evaluation according to Fraunhofer
- GLP compliance:
- yes (incl. QA statement)
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- Amantadine hydrochloride
- EC Number:
- 211-560-2
- EC Name:
- Amantadine hydrochloride
- Cas Number:
- 665-66-7
- Molecular formula:
- C10H17N.ClH
- IUPAC Name:
- adamantan-1-amine hydrochloride
- Test material form:
- other: solid
- Details on test material:
- Name of test material (as cited in study report): 1-Aminoadamantanhydrochlrid
Analytical purity: 99.7 g/100g by 1H-NMR spectroscopy using the internal standard method (determined during the GLP-study No.
11 L00389 from Competence Center Analytics, BASF SE)
Lot/batch No.: 20110315
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- other: d(0,1)
- Mean:
- 179 µm
- Percentile:
- other: d(0,5)
- Mean:
- 478 µm
- Percentile:
- other: d(0,9)
- Mean:
- 1 074 µm
- Percentile:
- other: D[3,2]
- Mean:
- 261 µm
- Percentile:
- other: D[4,3]
- Mean:
- 561 µm
Particle size distribution at different passagesopen allclose all
- Size:
- < 100 µm
- Distribution:
- 4.8 %
- Size:
- < 10 µm
- Distribution:
- 0.3 %
- Size:
- < 4 µm
- Distribution:
- 0 %
Any other information on results incl. tables
Results in detail:
| Measurement | d(0.1) [µm] |
d(0.5) [µm] |
d(0.9) [µm] |
D[3,2] [µm] |
D[4,3] [µm] |
| 1 | 183.105 | 483.874 | 1083.714 | 270.836 | 567.448 |
| 2 | 175.448 | 472.009 | 1063.978 | 252.699 | 555.121 |
| Mean* | 179 | 478 | 1074 | 261 | 561 |
*Using all single measuring points from the distributions 1 and 2, a new distribution was calculated, giving the mean values for each parameter.
< 100 µm: 4,8%; < 10 µm: 0,3%; < 4 µm: 0,0%
Applicant's summary and conclusion
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.
