Registration Dossier
Registration Dossier
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EC number: 260-086-2 | CAS number: 56271-94-4
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- 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:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- Principles of method if other than guideline:
- The sample was observed under 3 conditions: Direct observation, under a microscope with 100 x magnification, under a microscope with 400 x magnification. The physical characteristics of the material were recorded, noting such items as shape and size distribution.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and G316533
- Expiration date of the lot/batch: 25 March 2018
- Purity test date: 22 August 2017 - Remarks on result:
- other: 12.52 % by volume of sample was seen to be < 10.00 µm.
- Key result
- Percentile:
- D10
- Mean:
- 53.005 µm
- St. dev.:
- 0.195
- Remarks on result:
- other: % STDVP 0.4
- Key result
- Percentile:
- D50
- Mean:
- 130.126 µm
- St. dev.:
- 0.166
- Remarks on result:
- other: % STDVP 0.1
- Key result
- Percentile:
- D90
- Mean:
- 227.605 µm
- St. dev.:
- 0.45
- Remarks on result:
- other: %STDVP 0.2
- Conclusions:
- The particle sizes were distributed (D10-D90) between 53 and 227.6µm with the median particle size (50th %tile) 130.126 µm. 12.5% of the particles were <10µm and 31% of particles were <100µm.
Reference
Standard visual observation
Sample observed to be a fine and medium size, light brown powder with clusters.
Observation at 100 x magnification
The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately < 10 µm and the largest individual size was approximately 259 µm.
Observation at 400 x magnification
The sample was observed to be made up of single crystalline particles.
Description of key information
The particle sizes were distributed (D10-D90) between 53 and 227.6µm with the median particle size (50th %tile) 130.126 µm. 12.5% of the particles were <10µm and 31% of particles were <100µm.
Additional information
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