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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
Study period:
2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail; however, non-GLP
Qualifier:
no guideline followed
Principles of method if other than guideline:
Laser diffraction
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Percentile:
D10
Mean:
1.82 µm
Remarks on result:
other: standard deviation not available
Percentile:
other: D25
Mean:
4.08 µm
Remarks on result:
other: standard deviation not available
Percentile:
D50
Mean:
9.05 µm
Remarks on result:
other: standard deviation not available
Percentile:
D90
Mean:
64.58 µm
Remarks on result:
other: standard deviation not available
Conclusions:
Average size of particles = 24.657 μm
D10 = 1.82 μm
D25 = 4.08 µm
D50 = 9.05 μm
D90 = 64.58 μm
The study was performed in accordance with generally accepted scientific standards and described in sufficient detail and therefore reliability of Klimisch 2 has been assigned.
Executive summary:

The particle size distribution of the test substance was investigated by laser diffraction based on Mie Scattering (non-GLP, 2014) and the average size of particles has been determined to be 24.657 µm (D10 = 1.82 µm, D25 = 4.08µm, D50 = 9.05 µm, D90 = 64.58 µm).

According to the results, the inhalation of particles has to be regarded:

- ~ 92% are <100 µm (inhalable fraction)

- ~ 55% are <10 µm (thoracic fraction)

- ~25% are < 4µm (respirable fraction)

Description of key information

Specific surface area: 1.45 m2/g, Surface weighted mean D [3,2]: 4.151 µm, Vol. weighted mean D [4,3]: 24.657 μm

D（0.10): 1.82 μm; D (0.25): 4.08 µm, D（0.50): 9.05 μm, D (0.55): 10.54 µm, D（0.90): 64.58 μm, D (0.95): 121.58 µm

(laser diffractometry)

Additional information