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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:
other: European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002).
Deviations:
no
Qualifier:
according to
Guideline:
other: Commission Regulation (EC) No 440/2008 (as amended) of 30 May 2008.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
sieving
Remarks:
Along with Cascade Impactor method
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: MC-20/2014 (China)
- Expiration date of the lot/batch: 28 October 2019
- Storage conditions: Frozen in the dark
Mass median aerodynamic diameter:
> 10 µm
Percentile:
D50
Mean:
> 10 µm
Remarks on result:
other: 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:
95.9 %
Remarks on result:
other: Percentage of test item with an inhalable particle size <100 μm
No.:
#2
Size:
< 10 µm
Distribution:
0.27 %
Remarks on result:
other: Percentage of test item with a thoracic particle size <10.0 μm
No.:
#3
Size:
< 5.5 µm
Distribution:
0.17 %
Remarks on result:
other: Percentage of test item with a respirable particle size <5.5 μm

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

 

Measurement

Result

Mass of test item transferred to sieve

10.1 g

Mass of test item passed through sieve

9.7 g

Percentage of test item less than 100 µm

95.9 %

 

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

0.45

0.32

0.25

Cup 1

>10.0

2.5985

2.7823

2.7263

Cup 2

5.5 to 10.0

0.0035

0.0037

0.0019

Cup 3

2.4 to 5.5

0.0041

0.0011

0.0000

Cup 4

1.61 to 2.4

0.0032

0.0000

0.0000

Cup 5

0.307 to 1.61

0.0015

0.0003

0.0000

Final Filter

<0.307

0.0052

0.0005

0.0000

Total mass of collected test item

3.0660

3.1079

2.9782

Mass of test item added

3.0782

3.0696

2.9661


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

0.0175

0.0056

0.0019

0.57

0.18

0.064

<5.5

0.0140

0.0019

0.0000

0.46

0.06

0.00

<2.4

0.0099

0.0008

0.0000

0.32

0.03

0.00

<1.61

0.0067

0.0008

0.0000

0.22

0.03

0.00

<0.307

0.0052

0.0005

0.0000

0.17

0.02

0.00

 

Mean cumulative percentage with a particle size less than 10.0 µm: 0.27%

Mean cumulative percentage with a particle size less than 5.5 µm: 0.17%

Conclusions:
Particle size data acquired for the test item is as follows:
Percentage with an inhalable particle size <100 µm (Sieve Method): 95.9 %
Percentage with a thoracic particle size <10.0 µm (Cascade Impactor): 0.27 %
Percentage with a respirable particle size <5.5 µm (Cascade Impactor): 0.17 %
Executive summary:

The particle size distribution of FAT 40061/F was according to European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002). The study included a screening test which was performed using a sieving apparatus with a 100 µm stainless steel mesh used as sieve to find out the the percentage of test item with a particle size less than 100 µm. In the second stage, cascade impactor was used to find out the percentage of test with a particle size range of nominally 0.3 to 10 µm. Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes then sampled from the top, middle and bottom. Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.

Particle size data acquired for the FAT 40067/F is:

Percentage with an inhalable particle size <100 µm (Sieve Method): 95.9 %

Percentage with a thoracic particle size <10.0 µm (Cascade Impactor): 0.27 %

Percentage with a respirable particle size <5.5 µm (Cascade Impactor): 0.17 %

Description of key information

Particle size data acquired for the FAT 40067/F was determined as follows:

Percentage with an inhalable particle size <100 µm (Sieve Method): 95.9 %

Percentage with a thoracic particle size <10.0 µm (Cascade Impactor): 0.27 %

Percentage with a respirable particle size <5.5 µm (Cascade Impactor): 0.17 %

Additional information

The particle size distribution of FAT 40061/F was determined according to European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002). The study included a screening test which was performed using a sieving apparatus with a 100 µm stainless steel mesh used as sieve to find out the percentage of test item with a particle size less than 100 µm. In the second stage, cascade impactor was used to find out the percentage of test with a particle size range of nominally 0.3 to 10 µm. Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes then sampled from the top, middle and bottom. Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.

Particle size data acquired for the FAT 40067/F is:

Percentage with an inhalable particle size <100 µm (Sieve Method): 95.9 %

Percentage with a thoracic particle size <10.0 µm (Cascade Impactor): 0.27 %

Percentage with a respirable particle size <5.5 µm (Cascade Impactor): 0.17 %