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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: European Commission, ECB/TM/February 1996
Deviations:
no
GLP compliance:
yes
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
35.9 µm
Geometric standard deviation:
4.995
Percentile:
other: D5
Mean:
< 7.28 µm
St. dev.:
3.227
Percentile:
D10
Mean:
< 13.11 µm
St. dev.:
2.77
Percentile:
D50
Mean:
< 35.93 µm
St. dev.:
4.995
Percentile:
D90
Mean:
< 97.95 µm
St. dev.:
19.157
Conclusions:
The mass median diameter was determined to be 35.9 microns and the particle size distribution was found to range from approximately 0.5 microns to 275 microns.
Executive summary:

The particle size distribution of the test material was investigated in accordance with the European Commission, ECB/TM/February 1996 guideline under GLP conditions.

The particle size distribution was determined using the laser diffraction method. A solubility test showed that the test material was both sparingly soluble and well dispersed in water. Therefore, for the particle size distribution measurement, the test material was dispersed four times in pre-saturated water. Using the laser diffraction apparatus to study the particle size in the range between 0.3 microns and 300 microns, the particle size distribution and the mass median diameter were determined.

The mass median diameter was determined to be 35.9 microns and the particle size distribution was found to range from approximately 0.5 microns to 275 microns.

Description of key information

The particle size distribution was found to range from approximately 0.5 to 275 µm and the mass median diameter was determined to be 35.9 µm.

Additional information

The particle size distribution of the test material was investigated in accordance with the European Commission, ECB/TM/February 1996 guideline under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The particle size distribution was determined using the laser diffraction method. A solubility test showed that the test material was both sparingly soluble and well dispersed in water. Therefore, for the particle size distribution measurement, the test material was dispersed four times in pre-saturated water. Using the laser diffraction apparatus to study the particle size in the range between 0.3 microns and 300 microns, the particle size distribution and the mass median diameter were determined.

The mass median diameter was determined to be 35.9 microns and the particle size distribution was found to range from approximately 0.5 microns to 275 microns.