Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was conducted between 29 September 2015 and 24 February 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of particle tested:
other: Information not available
Type of distribution:
volumetric distribution
Key result
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Remarks:
No qualitative results determined
No.:
#1
Size:
< 100 µm
Distribution:
96.3 %
Remarks on result:
other: Percentage of test item with an inhable particle size < 100 µm.
No.:
#1
Size:
< 10 µm
Distribution:
<= 4.17 %
Remarks on result:
other: Percentage of test item with a thoracic particle size < 10 µm.
No.:
#1
Size:
< 5.5 µm
Distribution:
<= 0.647 %
Remarks on result:
other: Percentage of test item with a respirable particle size < 5.5 µm.

Sieve Screening Test

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

Measurement

Result

Mass of test item transferred to sieve

16.67 g

Mass of test item passed through sieve

16.05 g

Percentage of test item less than 100 µm

96.3 %

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

1.06

0.19

0.04

Cup 1

>10.0

2.0913

2.7972

2.9121

Cup 2

5.5 to 10.0

0.0069

0.0249

0.0206

Cup 3

2.4 to 5.5

0.0027

0.0103

0.0075

Cup 4

1.61 to 2.4

0.0012

0.0037

0.0033

Cup 5

0.307 to 1.61

0.0009

0.0026

0.0025

Final filter

<0.307

0.0009

0.0030

0.0026

Total mass of collected test item

3.16

3.03

2.99

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

0.0126

0.0445

0.0365

0.398

1.47

1.22

<5.5

0.0057

0.0196

0.0159

0.180

0.647

0.532

<2.4

0.0030

0.0093

0.0084

0.095

0.307

0.281

<1.61

0.0018

0.0056

0.0051

0.057

0.185

0.171

<0.307

0.0009

0.0030

0.0026

0.028

0.099

0.087

Mean cumulative percentage with a particle size less than 10.0 µm: ≤ 1.47

Mean cumulative percentage with a particle size less than 5.5 µm: ≤ 0.647

Conclusions:
Particle size data acquired for the test item is:
Percentage of test item with an inhalable particle size <100 µm (sieve method): 96.3 %
Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor):≤ 1.47 %
Percentage of test item with a respirable particle size <5.5 µm (cascade impactor): ≤ 0.647 %
Executive summary:

Particle Size Distribution. Particle size data was acquired, 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). The results are as follows:

Percentage of test item with an inhalable particle size <100 µm (sieve method): 96.3 %

Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor): ≤ 1.47 %

Percentage of test item with a respirable particle size <5.5 µm (cascade impactor): ≤ 0.647 %

Description of key information

Particle Size Distribution. 

Percentage of test item with an inhalable particle size <100 µm (sieve method): 96.3 %

Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor): ≤ 1.47 %

Percentage of test item with a respirable particle size <5.5 µm (cascade impactor): ≤ 0.647 %

Additional information

Percentage of test item with an inhalable particle size <100 µm (sieve method): 96.3 %

Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor): ≤ 1.47 %

Percentage of test item with a respirable particle size <5.5 µm (cascade impactor): ≤ 0.647 %