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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:
03 December 2018 to 10 June 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of Inspection: 21 August 2018 Date of Issue: 19 November 2018
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Remarks on result:
not determinable
Remarks:
Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.
No.:
#1
Size:
<= 100 µm
Distribution:
7.49 %

The results of the sieving procedure are shown in the following table:

Table 1

Measurement

Result

Mass of test item transferred to sieve (W1)

12.02 g

Mass of test item passed through sieve (W3– W2)

0.90 g

Percentage of test item less than 100 µm

7.49 %

Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Conclusions:
The percentage of test item having an inhalable particle size of less than 100 µm was determined to be 7.49%. The test item has been considered to be essentially non-inhalable.
Executive summary:

The proportion of test item having an inhalable particle size of less than 100 µm was determined by a sieve method to be 7.49%, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002). In accordance with this guidance document, the screening procedure was followed. Since there was a very small percentage of particles found to have a particle size of <100 µm, further testing was not required.

Description of key information

7.49% of particles with a particle size < 100 µm; EUR 20268; Fox J M 2019

Additional information