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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:
18 September 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A non-GLP study conducted to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.
Qualifier:
no guideline followed
Principles of method if other than guideline:
A standard method using a Coulter LS particle size analyser was used. The model was an optical model Fraunhofer (PIDS included). The pre-treatment consisted of agitation of the sample with 30 ml TPPS (5%) for 2 minutes at 500 rpm. The run length was 65 seconds with pump speed set to 51, obscuration 25% and PIDS obscuration at 97%. The fluid used was water.
GLP compliance:
not specified
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Percentile:
D50
Mean:
ca. 2.068 µm
Remarks on result:
other: No source field for Standard deviation.
No.:
#1
Size:
< 100 µm
Distribution:
> 100 %
No.:
#2
Size:
< 8 µm
Distribution:
> 75 %

Please see attached report for tabulated results.

Conclusions:
The particle size distribution test indicates that 100% of the substance has particles with a diameter up to 64.0 µm; the median particle size of the substance was determined to be 2.068 µm. More specifically, 83.4 % of particles were up to 12.00 µm, 75.1 % of particles were up to 8.00 µm, and 61.0 % of particles were up to 4.00 µm in diameter.
Executive summary:

The particle size distribution of the test material was investigated following a standard method using a Coulter LS particle size analyser . The model was an optical model Fraunhofer (PIDS included). The pre-treatment consisted of agitation of the sample with 30 mL TPPS (5%) for 2 minutes at 550 rpm. The run length was 65 seconds with pump speed set to 51, obscuration 8% and PIDS obscur at 59%. The fluid used was water.

The particle size distribution test indicates that 100% of the substance has particles with a diameter up to 64.0 µm; the median particle size of the substance was determined to be 2.068 µm. More specifically, 83.4 % of particles were up to 12.00 µm, 75.1 % of particles were up to 8.00 µm, and 61.0 % of particles were up to 4.00 µm in diameter.

Description of key information

61% of particles ≤ 4.0 µm, 75.1% of particles ≤ 8.0 µm; 83.4% of particles ≤ 12.0 µm; 100% of particles ≤ 64.0 µm; Coulter LS particle size analyser (volumteric distribution) (2008)

Additional information

The particle size distribution test indicates that 100% of the substance has particles with a diameter up to 64.0 µm; the median particle size of the substance was determined to be 2.068 µm. More specifically, 83.4 % of particles were up to 12.00 µm, 75.1 % of particles were up to 8.00 µm, and 61.0 % of particles were up to 4.00 µm in diameter.