4,11-diamino-2-(3-methoxypropyl)-1H-naphth[2,3-f]isoindol-1,3,5,10(2H)-tetrone

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: ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, given in European Commission Guidance Document EUR 20268, 2002

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

yes

Type of method:

cascade impaction

Type of distribution:

mass based distribution

Mass median aerodynamic diameter:

> 100 µm

Percentile:

D50

Mean:

> 100 µm

Remarks on result:

other: Std deviation not specified

No.:

#1

Size:

< 100 µm

Distribution:

24.3 %

Remarks on result:

other: Sieve method

No.:

#2

Size:

< 10 µm

Distribution:

0.64 %

Remarks on result:

other: Cascade Impactor

No.:

#3

Size:

< 5.5 µm

Distribution:

0.18 %

Remarks on result:

other: Cascade Impactor

Sieve Screening Test

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

 

Measurement	Result
Mass of test item transferred to sieve	11.06 g
Mass of test item passed through sieve	2.69 g
Percentage of test item less than 100 µm	24.3%

 

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	0.50	0.77	0.05
Cup 1	>10.0	2.3648	1.9971	2.6209
Cup 2	5.5 to 10.0	0.0102	0.0123	0.0158
Cup 3	2.4 to 5.5	0.0013	0.0016	0.0057
Cup 4	1.61 to 2.4	0.0004	0.0010	0.0009
Cup 5	0.307 to 1.61	0.0009	0.0006	0.0011
Final Filter	<0.307	0.0004	0.0004	0.0004
Total mass of collected test item		2.8780	2.7830	2.6948

 

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	0.0132	0.0159	0.0239	0.46	0.57	0.89
<5.5	0.0030	0.0036	0.0081	0.10	0.13	0.30
<2.4	0.0017	0.0020	0.0024	0.06	0.07	0.09
<1.61	0.0013	0.0010	0.0015	0.05	0.04	0.06
<0.307	0.0004	0.0004	0.0004	0.01	0.01	0.02

 

Mean cumulative percentage with a particle size less than 10.0 µm: 0.64

Mean cumulative percentage with a particle size less than 5.5 µm: 0.18

Conclusions:

Particle size data acquired for the test item is:
Percentage of test item with an inhalable particle size <100 µm (Sieve Method) was 24.3 %.
Percentage of test item with a thoracic particle size <10.0 µm (Cascade Impactor) was 0.64 %
Percentage of test item with a respirable particle size <5.5 µm (Cascade Impactor) was 0.18 %

Executive summary:

Particle size distribution of FAT 36152/M was investigated using the 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:

 

Measurement	Method	Result
Proportion of test item having an inhalable particle size <100 µm	Sieve	24.3%
Proportion of test item having a thoracic particle size <10.0 µm	Cascade Impactor	0.64%
Proportion of test item having a respirable particle size <5.5 µm	Cascade Impactor	0.18%

 

Description of key information

Particle size data acquired for FAT 36152/M is:
Percentage of test item with an inhalable particle size <100 µm (Sieve Method) was 24.3 %.
Percentage of test item with a thoracic particle size <10.0 µm (Cascade Impactor) was 0.64 %
Percentage of test item with a respirable particle size <5.5 µm (Cascade Impactor) was 0.18 %

Additional information

Particle size distribution of FAT 36152/M was investigated using the 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:

 

Measurement	Method	Result
Proportion of test item having an inhalable particle size <100 µm	Sieve	24.3%
Proportion of test item having a thoracic particle size <10.0 µm	Cascade Impactor	0.64%
Proportion of test item having a respirable particle size <5.5 µm	Cascade Impactor	0.18%