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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:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: European Commission Technical 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
Remarks:
Additionally Cascade Impactor method
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: MH-12/2014 (China)
- Expiration date of the lot/batch: 13 November 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Frozen in the dark
Percentile:
D50
Remarks on result:
not measured/tested
No.:
#1
Size:
< 10 µm
Distribution:
2.89 %
Remarks on result:
other: Mean cumulative percentage
No.:
#2
Size:
< 5.5 µm
Distribution:
0.5 %
Remarks on result:
other: Mean cumulative percentage
No.:
#3
Size:
< 100 µm
Distribution:
53.6 %
Remarks on result:
other: Mean cumulative percentage

Sieve Screening Test

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

 

Measurement

Result

Mass of test item transferred to sieve

10.79 g

Mass of test item passed through sieve

5.78 g

Percentage of test item less than 100 µm

53.6 %

 

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

0.35

0.50

0.54

Cup 1

>10.0

2.4883

2.4210

2.2304

Cup 2

5.5 to 10.0

0.0628

0.0762

0.0710

Cup 3

2.4 to 5.5

0.0078

0.0107

0.0127

Cup 4

1.61 to 2.4

0.0014

0.0013

0.0001

Cup 5

0.307 to 1.61

0.0005

0.0011

0.0016

Final Filter

<0.307

0.0011

0.0006

0.0050

Total mass of collected test item

2.9119

3.0109

2.8608

 

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

0.0736

0.0899

0.0904

2.53

2.99

3.16

<5.5

0.0108

0.0137

0.0194

0.37

0.46

0.68

<2.4

0.0030

0.0030

0.0067

0.10

0.10

0.23

<1.61

0.0016

0.0017

0.0066

0.06

0.06

0.23

<0.307

0.0011

0.0006

0.0050

0.04

0.02

0.18

 

Mean cumulative percentage with a particle size less than 10.0 µm: 2.89

Mean cumulative percentage with a particle size less than 5.5 µm: 0.50

Conclusions:
The percentage of test item with an inhalable particle size <100 µm (sieve method) was 53.4 %.
The percentage of test item with a thoracic particle size <10.0 µm (cascade impactor) was 2.89 %.
The percentage of test item with a respirable particle size <5.5 µm (cascade impactor) was 0.50 %.
Executive summary:

The particle size distribution of FAT 40069/D was determined according to 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 study was conducted by using Sieve Screening Test and Cascade Impactor methods and the study results are as follows:

 

The percentage of test item with

- an inhalable particle size <100 µm (sieve method) was 53.4 %.

- a thoracic particle size <10.0 µm (cascade impactor) was 2.89 %.

- a respirable particle size <5.5 µm (cascade impactor) was 0.50 %.

Description of key information

The particle size distribution of FAT 40069/D was determined according to 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 study conducted by using Sieve Screening TestandCascade Impactor methods. The following results have been obtained:

The percentage of test item with

- an inhalable particle size <100 µm (sieve method) was 53.4 %.

- a thoracic particle size <10.0 µm (cascade impactor) was 2.89 %.

- a respirable particle size <5.5 µm (cascade impactor) was 0.50 %.

Additional information

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