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Diss Factsheets

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:
2014-03-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted using a relevant test method, but not in compliance with GLP.
Principles of method if other than guideline:
The granulometry of the substance was determined using the screening method (light microscopic examination).
GLP compliance:
no
Type of method:
microscopic examination
Type of particle tested:
aggregate
Type of distribution:
mass based distribution
Key result
Percentile:
D50
Remarks on result:
other: No particles smaller than 100 µm are present in the substance, the size of the granules ranges from 1-10 mm.

Size of test substance granules was examined by light microscope several times.

As the sample was extracted at random, and no factor is known to generate bias towards particle size distribution within the batch in the production, the sample is representative of the batch and accordingly the examination is expected to demonstrate the representative particle size distribution of the batch.

The smallest size is about 1 mm, and the largest is less than 10 mm. In all examinations, no particles smaller than 100 μm were seen.

Conclusions:
The particle size of the substance was determined using a light microscopic examination. No particles smaller than 100 µm were present in the substance; the size of the granules ranged from 1-10 mm. The result is reliable.

Description of key information

Granulometry: No particles smaller than 100 µm are present in the substance; the size of the granules ranges from 1-10 mm

Additional information

The particle size of the substance was determined using a light microscopic examination. No particles smaller than 100 µm were present in the substance; the size of the granules ranged from 1-10 mm. The result is considered to be reliable.