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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:
From July 18, 2017 to August 24, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to guideline
Guideline:
other: Microscopic and manual sieve analysis method
Deviations:
not specified
GLP compliance:
yes
Type of method:
other: Microscopic and manual sieve analysis
Type of particle tested:
other: Sample tested as received
Type of distribution:
mass based distribution
Mass median aerodynamic diameter:
> 2 000 µm
No.:
#1
Size:
> 2 000 µm
Distribution:
ca. 100 other: % by weight
No.:
#2
Size:
< 2 000 µm
Distribution:
ca. 0 other: % by weight

Results

a) Standard visual observation

Sample observed to be an amorphous non-dusting off-white solid.

b) Observation using 3.2 objective lens

The particles appeared to be irregular shaped particles. All particles were > 2000 μm.

c) Observation using 40 objective lens

The sample was observed to be a solid block with some broken bits. All particles were > 2000 μm.

Full test results

Sieve size (μm)

Sieve weight (g)

Sieve + powder weight (g)

Powder weight (g)

% by weight

< 2000

352.25

352.25

0

0

> 2000

325.88

329.14

3.3

100

Total

3.3

100

Comments

The sample was found to be a solid block with a few broken bits. During the sieve analysis, only 3.3 g of the sample poured into the sieve. The remaining portion of the sample remained as a solid block. All the particles that went into the sieve were > 2000 μm. Because these particles were greater than the upper limit of detection for the distribution analysis, no further testing was performed.

Conclusions:
Under the study conditions, the test substance particles were determined to be > 2000 μm.
Executive summary:

A study was conducted to determine the particle size distribution of the test substance, using microscopic examination and manual sieve analysis, in compliance with GLP. In the microscopic visual examination, the test substance was observed to be an amorphous non-dusting off-white solid. While using 3.2 objective lens, the particles appeared to be irregular shaped particles, in which all particles were > 2000 μm. Observation using 40 objective lens, the sample was observed to be a solid block with some broken bits, with all particles were > 2000 μm. During the sieve analysis, only 3.3 g of the sample poured into the sieve. The remaining portion of the sample remained as a solid block. All the particles that went into the sieve were > 2000 μm. Because these particles were greater than the upper limit of detection for the distribution analysis, no further testing was performed. Under the study conditions, the test substance particles were determined to be > 2000 μm (Chilworth, 2017).

Description of key information

The particle size distribution of the test substance was determined using microscopic examination and manual sieve analysis (Chilworth, 2017).

Additional information

> 2000 μm