Registration Dossier
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EC number: 826-676-4 | CAS number: 521065-36-1
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
- Study period:
- From 2019-11-04 to 2019-11-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- 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:
- Batch No.: 190722
Purity: > 99 wt% - Mass median aerodynamic diameter:
- 47.3 µm
- Geometric standard deviation:
- 2.559
- Remarks on result:
- other: Mean of five runs
- Percentile:
- D10
- Mean:
- 7.92 µm
- St. dev.:
- 0.159
- Percentile:
- D50
- Mean:
- 30.6 µm
- St. dev.:
- 0.68
- Percentile:
- D90
- Mean:
- 90.6 µm
- St. dev.:
- 3.82
- Conclusions:
- The D50 of the test item was determined to be 30.6 μm, the D10 was 7.92 μm and the D90 was 90.6 μm. The MMAD of the test item, for the relative density and the mean d50, was calculated to be 47.3 μm.
- Executive summary:
The particle size distribution of the test item was determined by means of Laser Diffraction Analysis using the medium volume (wet) module (MVM) based on the method as described in ISO 13320:2009.
The D50 of the test item was determined to be 30.6 μm, the D10 was 7.92 μm and the D90 was 90.6 μm. The MMAD of the test item, for the relative density and the mean d50, was calculated to be 47.3 μm.
Reference
The coefficient of variation for d50 is less than 3%, and for d10 and d90 is less than 5%. It can be concluded that the repeatability of the measured particle size distributions is within the acceptable limits.
Description of key information
The particle size distribution of the test item was determined by means of Laser Diffraction Analysis using the medium volume (wet) module (MVM) based on the method as described in ISO 13320:2009.
The D50 of the test item was determined to be 30.6 μm, the D10 was 7.92 μm and the D90 was 90.6 μm. The MMAD of the test item, for the relative density and the mean d50, was calculated to be 47.3 μm.
Additional information
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