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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:
23 January - 22 April, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method, and under GLP. No deviation was reported. Test substance is adequately specified with isomer purity. Therefore full validation applies.
Qualifier:
equivalent or similar to
Guideline:
other: EUR 20268 EN: Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances (European Commission, 2002)
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP compliance programme (inspected on 05 February 2014 / signed on 07 October 2015)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Percentile:
D10
Mean:
84.5 µm
St. dev.:
0.7
Percentile:
D50
Mean:
330 µm
St. dev.:
3
Percentile:
D90
Mean:
783 µm
St. dev.:
3
No.:
#1
Size:
< 500 µm
Distribution:
70 %
No.:
#2
Size:
< 100 µm
Distribution:
13 %
No.:
#3
Size:
< 10 µm
Distribution:
0 %
No.:
#4
Size:
< 4 µm
Distribution:
0 %

The overall mean values for the 10%, 50% and 90% quantile results are presented in the following table:

 

Parameter

Size (μm)

d(0.1)

84 (mean of 85 and 84)

d(0.5)

330 (mean of 332 and 328)

d(0.9)

783 (mean of 781 and 785)

 

The cumulative percentages of fractions below specific sizes were also determined to be as follows:

 

Fraction

Cumulative volume %

< 500 μm

70 (mean of 70 and 70)

< 100 μm

13 (mean of 13 and 13)

< 10 μm

0

< 4 μm

0

The curves show a Gaussian-type distribution, non-symetric (wider on the low-size edge).

Conclusions:
The test substance contains a limited fraction of particles fine enough to be inhaled, but they are not anticipated to reach the thoracic fraction.
Dust explosion potential should be considered.
Executive summary:

The size distribution of particles present in the test substance was assessed using particle size apparatus based on laser diffraction (cited in EUR 20268 EN Guidance Document).

Measurement was performed in duplicate.

The mean median diameter is 330 µm.

With regard to inhalation potential, about 13% of total particles are smaller than 100 µm, and 0% could reach the thoracic fraction (<10 µm).

Fine particles relevant to dust explosion hazard (<500 µm) account for 70%.

Description of key information

Median diameter = 330 µm
Inhalable fraction (<100µm) = 13%, Thoracic fraction (<10µm) = 0%.
Dust particles (<500µm) = 70% (dust explosion potential)

Additional information

A fully reliable experimental study, conducted according to a method cited in EU guidance, and under GLP, is available. It is considered as a key study.