N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide

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:

As well as Cascade Impactor

Type of particle tested:

other:

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 12-45 (China)
- Expiration date of the lot/batch: 05 March 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark

Percentile:

D50

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

No.:

#1

Size:

< 100 µm

Distribution:

15 %

No.:

#2

Size:

< 10 µm

Distribution:

1.16 %

No.:

#3

Size:

< 5.5 µm

Distribution:

0.18 %

Sieve Screening Test

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

 

Measurement	Result
Mass of test item transferred to sieve	11.62 g
Mass of test item passed through sieve	1.74 g
Percentage of test item less than 100 µm	15.0 %

 

 

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	1.09	0.27	0.26
Cup 1	>10.0	4.6710	2.6222	2.6426
Cup 2	5.5 to 10.0	0.0321	0.0321	0.0388
Cup 3	2.4 to 5.5	0.0012	0.0031	0.0052
Cup 4	1.61 to 2.4	0.0000	0.0000	0.0015
Cup 5	0.307 to 1.61	0.0000	0.0000	0.0011
Final Filter	<0.307	0.0015	0.0014	0.0019
Total mass of collected test item		5.7958	2.9288	2.9511

*Taken from cumulative weights of two determinations from the top layer.

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	0.0348	0.0366	0.0485	0.60	1.25	1.64
<5.5	0.0027	0.0045	0.0097	0.05	0.15	0.33
<2.4	0.0015	0.0014	0.0045	0.03	0.05	0.15
<1.61	0.0015	0.0014	0.0030	0.03	0.05	0.10
<0.307	0.0015	0.0014	0.0019	0.03	0.05	0.06

Mean cumulative percentage with a particle size less than 10.0 µm: 1.16%

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

*Taken from cumulative weights of two determinations from the top layer.

Conclusions:

Particle size data acquired for FAT 36034/H is as follows:
Percentage of test item with an inhalable particle size <100 µm (sieve method) is 15.0 %
Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor method) is 1.16 %
Percentage of test item with a respirable particle size <5.5 µm (cascade impactor method) is 0.18 %

Executive summary:

The particle size distribution of FAT36034/H TE has been determined, 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). 

Particle size data acquired for FAT 36034/H TE is as follows:

Percentage of test item with an inhalable particle size <100 µm (sieve method) is 15.0 %

Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor method) is 1.16 %

Percentage of test item with a respirable particle size <5.5 µm (cascade impactor method) is 0.18 %

 

Description of key information

Particle size data acquired for FAT 36034/H is as follows:
Percentage of test item with an inhalable particle size <100 µm (sieve method) is 15.0 %
Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor method) is 1.16 %
Percentage of test item with a respirable particle size <5.5 µm (cascade impactor method) is 0.18 %