Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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:
- 07 November 2011-17 November 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to appropriate guidelines and according to the principles of GLP.
- Qualifier:
- according to guideline
- Guideline:
- other: The test was conducted in accordance with ISO 13320:2009 and CIPAC MT 187 and took into consideration OECD guideline 110
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Mass median aerodynamic diameter:
- 126.568 µm
- Percentile:
- D10
- Mean:
- 7.401 µm
- St. dev.:
- 1.81
- Remarks on result:
- other: Average of 5 runs
- Percentile:
- D50
- Mean:
- 102.324 µm
- St. dev.:
- 2.65
- Remarks on result:
- other: Average of 5 runs
- Percentile:
- D90
- Mean:
- 351.112 µm
- St. dev.:
- 2.12
- Remarks on result:
- other: Average of 5 runs
- No.:
- #1
- Size:
- < 10 µm
- Distribution:
- 12.23 %
- Conclusions:
- Particle Size Analysis (laser diffraction-wet' small volume module) results for FAT 41043/A:
MMAD= 126.568 µm; 10 % is <7.401 µm; 12.23 % is <10 µm; 50 % is <102.324 µm and 90 % is <351.112 µm.
Reference
Volume weighted Mean: 146.039 µm (average of 5 runs)
Mode: 177.718 µm (average of 5 runs)
Coefficient of variation for d50 is less than 3 %; d10 and d90 are less than 5 %. Thus, repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.
Description of key information
MMAD= 126.568 µm; D50= 102.324 µm; D10= 7.401 µm and D90= 351.112 µm (Laser diffraction analysis-'wet' small volume dispersion method).
Additional information
12.23% by volume is < 10 µm
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