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Particle size distribution (Granulometry)

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particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2013-03-12 to 2013-03-18
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
The study was conducted according to a recommended EU method, and under GLP. No deviation affected the quality of the study, however a limit test was performed rather than a complete distribution. The substance is considered to be adequately characterised with its purity. Therefore validation applies with restrictions.
according to guideline
other: European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002)
GLP compliance:
yes (incl. QA statement)
Inspected on 10 July 2012 / Signed on 30 November 2012
Type of method:
Limit test: sieving through 100 µm mesh, with mechanical shaking.
Type of distribution:
mass based distribution
100 µm
2.8 %
Remarks on result:
other: passing

Mass of test item transferred to sieve = 14.23 g

Mass of test item passed through sieve = 0.40 g

Low inhalation exposure potential is anticipated from dust.
Executive summary:

Particle size distribution of the test substance was determined by sieving of a single sample on a 100 µm mesh, corresponding to the cut-off size for inhalable particles.

Particles larger than 100 µm represent 97.2%.

Description of key information

With 97.2% of particles larger than 100 µm (i.e. not inhalable), low exposure potential is anticipated from dust.

Additional information

A reliable experimental study, conducted according to EC Guidance, is available. Despite restrictions as a limit test was performed rather than a complete distribution, it is considered reliable and sufficient for purpose, and therefore a key study.