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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance document, European Commission, ECB/TM/Feb 1996
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Key result
Percentile:
D10
Mean:
ca. 7.82 µm
St. dev.:
0.157
Key result
Percentile:
D50
Mean:
ca. 33.23 µm
St. dev.:
0.395
Key result
Percentile:
D90
Mean:
ca. 66.82 µm
St. dev.:
1.178
Conclusions:
With a median mass diameter of about 33.23 µm, more than 98% of the particles were smaller than 100µm.
Executive summary:

The particle size distribution of the test item was performed according to the EC Guidance Document ECB/TM/February 1996 "Particle Size Distribution, Fibre Length and Diameter Distribution" using laser diffraction.

Water was used as solvent. Two solutions were prepared, both measured in duplicate.

With a median mass diameter of about 33.23 µm, more than 98% of the particles were smaller than 100µm.

Description of key information

D10: ca. 7.82 µm
D50: ca. 33.23 µm
D90: ca. 66.82 µm
Test item is produced and used in its dissolved form: there is no chance of inhalative exposure during entiry life cycle

Additional information

With a median mass diameter of about 33.23 µm, more than 98% of the particles were smaller than 100µm.