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Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 18, 2017 to September 14, 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

other: ISO 2591-1

Version / remarks:

ISO 2591-1:1988, Test sieving -- Part 1: Methods using test sieves of woven wire cloth and perforated metal plate

Deviations:

not specified

Principles of method if other than guideline:

To characterise the particle size distribution of the test substance powder, the analysis was conducted initially using an optical microscope analysis and was then undertaken more formally using a manual sieve analysis.

GLP compliance:

yes

Type of method:

sieving

Remarks:

Microscopic examination also was performed

Type of particle tested:

other: Sample tested as received (white solid block)

Type of distribution:

mass based distribution

No.:

#1

Size:

> 2 000 µm

Distribution:

ca. 100 %

Remarks on result:

other: The test susbtance was found to be a solid block with few broken bits. During sieve analysis, only 3.3 g of the test substance poured into the sieve. The remaining portion of the test susbtance remained as a solid block.

Remarks:

All the particles that went into the sieve were greater than 2000 μm. Because these particles were greater than the upper limit of detection for the distribution analysis, no further testing was performed.

 1) Optical microscope analysis

In standard visual observation, test substance was observed to be a white block with few broken bits. All the particles were greater that 2000 μm. In observation using 3.2 objective lens, the particles were appeared to be irregular shaped crystals. Whereas in observation using 40 objective lens, all of the particles were greater than 2000 μm.

2) Manual sieve analysis

Full test results

Sieve size (μm)	Sieve weight (g)	Sieve + powder weight (g)	Powder weight (g)		% by weight
> 2000	325.88	326.65	0.8		100.0
< 2000	352.25	352.25	0.0		0.0
Total				0.8	100.0

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

Conclusions:

Under the study conditions, the particle size of the test substance was considered to be >2000 µm.

Executive summary:

A study was conducted to determine particle size distribution of the test substance, by optical microscopic and manual sieve analysis according to ISO 2591 -1 Method, in compliance with GLP. The test susbtance was found to be a solid block with few broken bits. During sieve analysis, only 3.3 g of the test substance was poured into the sieve. The remaining portion of the test susbtance remained as a solid block. All the particles that went into the sieve were greater than 2000 μm. Because test substance particles were greater than the upper limit of detection for the distribution analysis, the author concluded that no further testing was required. Under study conditions, the particle size of the test substance was considered to be >2000 µm (Chilworth, 2017).

Description of key information

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

Additional information

The particle size of the test substance was determined to be >2000 µm.