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Particle size distribution (Granulometry)

Link to relevant study record(s)

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 %.