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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 May 2010-13 May 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: BS ISO 13320-1:1999
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Remarks:
Preceded by manual sieve analysis (2000 µm)
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
248.9 µm
Key result
Percentile:
D50
Mean:
248.911 µm
Remarks on result:
other: St. dev not available
Percentile:
D10
Mean:
< 8.529 µm
St. dev.:
0.27
Percentile:
D50
Mean:
< 160.337 µm
St. dev.:
4.5
Percentile:
D90
Mean:
< 545.484 µm
St. dev.:
30
No.:
#1
Size:
< 2 000 µm
Distribution:
48.3 %
Remarks on result:
other: Manual sieve analysis prior to the laser diffraction test indicated that 48.3% by weight of the sample had a particle size of < 2000 µm.
No.:
#2
Size:
< 10 µm
Distribution:
11.247 %
Remarks on result:
other: Result is for the < 2000 µm fraction

The laser diffraction test was performed on the < 2000 µm sample and 11.247% was determined to be < 10 µm. From this it was calculated that 5.43% (11.247 x 48.3/100) of the test material is < 10 µm.

Conclusions:
The particle size distribution of the substance was determined by manual sieve analysis (2000 µm) followed by laser diffraction analysis-dry powder module (GLP-compliant study in accordance with OECD 110, ISO 13320 and CIPAC MT 187). Manual sieve analysis result: 48.3% by weight is < 2000 µm. Laser diffraction analysis result for the < 2000 µm fraction: MMAD= 248.9 µm, 10% is < 8.5 µm, 11.247% is < 10.00 µm, 50% is < 160.3 µm and 90% is < 545.48 µm.

Taken into account the percentage of test material that passed the 2000 µm sieve, 5.43% (11.247 x 48.3/100) of the test material is < 10 µm.

Description of key information

The particle size distribution of the substance was determined by manual sieve analysis (2000 µm) followed by laser diffraction analysis-dry powder module (GLP-compliant study in accordance with OECD 110, ISO 13320 and CIPAC MT 187). Manual sieve analysis result: 48.3% by weight is < 2000 µm. Laser diffraction analysis result for the < 2000 µm fraction: MMAD= 248.9 µm, 10% is < 8.5 µm,  11.247% is < 10.00 µm, 50% is < 160.3 µm and  90% is < 545.48 µm.

Additional information

The laser diffraction test was performed on the < 2000 µm sample and 11.247% was determined to be < 10 µm. From this it was calculated that 5.43% (11.247 x 48.3/100) of the test material is < 10 µm.