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EC number: 221-800-8 | CAS number: 3238-40-2
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:
- 24 July 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline followed and only 1 run was conducted. Still considered reliable as the study is performed with a commonly used apparatus and as the results are well described.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The analysis is conducted using Laser Diffraction Particle Size Analysis.
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Mass median aerodynamic diameter:
- 509.639 µm
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- D10
- Mean:
- 150.468 µm
- Remarks on result:
- other: (based on 1 run)
- Percentile:
- D50
- Mean:
- 387.471 µm
- Remarks on result:
- other: (based on 1 run)
- Percentile:
- D90
- Mean:
- 945.203 µm
- Remarks on result:
- other: (based on 1 run)
- Size:
- < 10 µm
- Distribution:
- 0.34 %
- Remarks on result:
- other: (based on 1 run)
- Conclusions:
- The particle size distribution of a sample of the substance was determined by laser diffraction analysis-dry powder module; 0.34% is < 10 µm; < 10% is < 150 µm; 50% is < 387 µm and 90% is < 945 µm. The MMAD was determined to be 510 µm.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 July 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline followed and only 1 run was conducted. Still considered reliable as the study is performed with a commonly used apparatus and as the results are well described.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The analysis is conducted using Laser Diffraction Particle Size Analysis.
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Mass median aerodynamic diameter:
- 637.354 µm
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- D10
- Mean:
- 187.384 µm
- Remarks on result:
- other: (based on 1 run)
- Percentile:
- D50
- Mean:
- 484.571 µm
- Remarks on result:
- other: (based on 1 run)
- Percentile:
- D90
- Mean:
- 1 032.097 µm
- Remarks on result:
- other: (based on 1 run)
- Size:
- < 10 µm
- Distribution:
- 0 %
- Remarks on result:
- other: (based on 1 run)
- Conclusions:
- The particle size distribution of a sample of the substance was determined by laser diffraction analysis-dry powder module; 0% is < 10 µm; 10% is < 187 µm; 50% is < 485 µm and 90% is < 1032 µm. The MMAD was determined to be 637 µm.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 July 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline followed and only 1 run was conducted. Still considered reliable as the study is performed with a commonly used apparatus and as the results are well described.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The analysis is conducted using Laser Diffraction Particle Size Analysis.
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Mass median aerodynamic diameter:
- 533.69 µm
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- D10
- Mean:
- 142.674 µm
- Remarks on result:
- other: (based on 1 run)
- Percentile:
- D50
- Mean:
- 405.757 µm
- Remarks on result:
- other: (based on 1 run)
- Percentile:
- D90
- Mean:
- 868.098 µm
- Remarks on result:
- other: (based on 1 run)
- Size:
- < 10 µm
- Distribution:
- 0.3 %
- Remarks on result:
- other: (based on 1 run)
- Conclusions:
- The particle size distribution of a sample of the substance was determined by laser diffraction analysis-dry powder module; 0.3% is < 10 µm; 10% is < 143 µm; 50% is < 406 µm and 90% is < 868 µm. The MMAD was determined to be 534 µm.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 July 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline followed and only 1 run was conducted. Still considered reliable as the study is performed with a commonly used apparatus and as the results are well described.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The analysis is conducted using Laser Diffraction Particle Size Analysis.
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Mass median aerodynamic diameter:
- 629.175 µm
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- D10
- Mean:
- 177.485 µm
- Remarks on result:
- other: (based on 1 run)
- Percentile:
- D50
- Mean:
- 478.353 µm
- Remarks on result:
- other: (based on 1 run)
- Percentile:
- D90
- Mean:
- 998.676 µm
- Remarks on result:
- other: (based on 1 run)
- Size:
- < 10 µm
- Distribution:
- 0.13 %
- Remarks on result:
- other: (based on 1 run)
- Conclusions:
- The particle size distribution of a sample of the substance was determined by laser diffraction analysis-dry powder module; 0.13% is µm < 10 µm; 10% is < 177 µm; 50% is < 478 µm and 90% is < 999 µm. The MMAD was determined to be 629 µm.
Referenceopen allclose all
Span: 2.051
Span: 1.743
Span: 1.788
Span: 1.717
Description of key information
The MMAD was determined to be 577 µm. D10= 164.5 µm; D50= 439 µm and D90= 961 µm; < 0.2% by volume is < 10 µm.
Additional information
Average of 4 analyses, on 4 different batches, determined by Laser diffraction analysis-dry powder module.
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