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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:
The study was conducted between 23 October 2014 and 01 July 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002.
Deviations:
no
Principles of method if other than guideline:
As per the above mentioned guideline
GLP compliance:
yes
Type of method:
cascade impaction
Type of distribution:
mass based distribution
Specific details on test material used for the study:
None
Mass median aerodynamic diameter:
other: Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
Key result
Percentile:
D50
Mean:
other: Can not be determined as too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
Remarks on result:
other: standard deviation not specified
No.:
#1
Size:
< 100 µm
Distribution:
92.2 %
No.:
#2
Size:
< 10 µm
Distribution:
0.231 %
No.:
#3
Size:
< 5.5 µm
Distribution:
0.161 %

Sieve Screening Test

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

Measurement

Results

Mass of test item transferred to sieve

14.69 g

Mass of test item passed through sieve

13.55 g

Percentage of test item less than 100 µm

92.2 %

Cascade Impactor

The results of the cascade impactor procedure are shown in the following table:

Collection Stage

Particle Size Range Collected (µm)

Collected Mass (g)

Determination 1

Determination 2

Determination 3

Artificial throat

n/a

0.67

0.17

0.41

Cup 1

>10.0

2.3362

2.8224

2.5858

Cup 2

5.5 to 10.0

0.0025

0.0025

0.0013

Cup 3

2.4 to 5.5

0.0020

0.0018

0.0007

Cup 4

1.61 to 2.4

0.0018

0.0016

0.0006

Cup 5

0.307 to 1.61

0.0017

0.0015

0.0007

Final Filter

<0.307

0.0007

0.0008

0.0006

Total mass of collected test item

3.0149

3.0006

2.9997

The cumulative amounts of test item collected in the three determinations for the individual particle size cut-points are shown in the following table:

Particle Size Cut Points (µm)

Cumulative Mass (g)

Cumulative Percentage (%)

Determination 1

Determination 2

Determination 3

Determination 1

Determination 2

Determination 3

<10.0

0.0087

0.0082

0.0039

0.289

0.273

0.130

<5.5

0.0062

0.0057

0.0026

0.206

0.190

0.087

<2.4

0.0042

0.0039

0.0019

0.139

0.130

0.063

<1.61

0.0024

0.0023

0.0013

0.080

0.077

0.043

<0.307

0.0007

0.0008

0.0006

0.023

0.027

0.020

Mean cumulative percentage with a particle size less than 10.0 µm: 0.231

Mean cumulative percentage with a particle size less than 5.5 µm: 0.161

Conclusions:
Percentage of test item with an inhalable particle size < 100 µm (sieve method) was 92.2 %
Percentage of test item with a thoracic particle size <10.0 μm (cascade impactor) was 0.231 %
Percentage of test item with a respirable particle size <5.5 μm (cascade impactor) was 0.161 %
Executive summary:

Particle size data was acquired, using a procedure designed to be compatible with European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’, 2002. The results are as follows:

Proportion of test item having an inhalable particle size <100 μm (Sieve) 92.2 %

Proportion of test item having a thoracic particle size <10.0 μm (Cascade Impactor) 0.231 %

Proportion of test item having a respirable particle size <5.5 μm (Cascade Impactor) 0.161 %

Description of key information

Proportion of test item having an inhalable particle size <100 μm (Sieve) 92.2 %
Proportion of test item having a thoracic particle size <10.0 μm (Cascade Impactor) 0.231 %
Proportion of test item having a respirable particle size <5.5 μm (Cascade Impactor) 0.161 %

Additional information

The particle size distribution was assessed using a procedure designed to be compatible with European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’, 2002.

The proportion of test item having an inhalable particle size < 100 μm was 92.2 %.

The proportion of test item having a thoracic particle size < 10 μm was 0.231 %

The proportion of test item having a respirable particle size < 5.5 μm was 0.161 %