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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:
19-23 November 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test performed at a GLP accredited laboratory.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Principles of method if other than guideline:
By Laser Diffraction Analyser
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Key result
Percentile:
D50
Mean:
388.3 µm
St. dev.:
2.13
Remarks on result:
other: mean value
Percentile:
D50
Mean:
479 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Remarks:
median value
No.:
#1
Size:
< 140.6 µm
Distribution:
10 %
No.:
#2
Size:
< 270.6 µm
Distribution:
25 %
No.:
#3
Size:
< 479.1 µm
Distribution:
50 %
No.:
#4
Size:
< 686.7 µm
Distribution:
75 %
No.:
#5
Size:
< 810 µm
Distribution:
90 %

Particles appear to be crystalline powder formed from agglomerated , sharp edged irregular shaped particles that was observed under amicroscope at 100x magnification. At 400x magnification, the sample was made up of agglomerated small particles.

Executive summary:

The particle size distribution has been determined in accordance with OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) by a Laser Diffraction Analyser:

Mean (µm) : 388.3
Median (µm) : 479.1
95 % Conf. Limits (µm): 88.5-1700

Description of key information

The particle size distribution is determined with a Laser Diffraction Particle Size Analyser under GLP compliance, similarly to the OECD Guideline 110. The mean and median are 388.3 µm and 479.1 µm, respectively.

Additional information

The particle size has a mean of 388.3 µm and a median of 479.1 µm. However, it should be noted that the particle size distribution depends on the production process and could be subject to large variation. Less than 10% of the product has a particle of 100 µm, meaning that less than 10% accounts for the inhalable fraction. Particles are irregularly shaped.