Reaction products of 1-(substitutedphenyl)urea coupled with diazotated potassium sodium substituted-5-{[2-(substituted)ethyl]sulfonyl}benzenesulfonate, further condensed with 2,4,6-trichloro-1,3,5-triazine, further converted with disubstituted benzene-1,4-disulfonic acid in aq. sodium hydroxide

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:

The study was conducted between 29 September 2015 and 24 February 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

other: European Commission 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

Type of particle tested:

other: Information not available

Type of distribution:

volumetric distribution

Key result

Percentile:

D50

Remarks on result:

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

Remarks:

No qualitative results determined

No.:

#1

Size:

< 100 µm

Distribution:

96.3 %

Remarks on result:

other: Percentage of test item with an inhable particle size < 100 µm.

No.:

#1

Size:

< 10 µm

Distribution:

<= 4.17 %

Remarks on result:

other: Percentage of test item with a thoracic particle size < 10 µm.

No.:

#1

Size:

< 5.5 µm

Distribution:

<= 0.647 %

Remarks on result:

other: Percentage of test item with a respirable particle size < 5.5 µm.

Sieve Screening Test

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

Measurement	Result
Mass of test item transferred to sieve	16.67 g
Mass of test item passed through sieve	16.05 g
Percentage of test item less than 100 µm	96.3 %

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	1.06	0.19	0.04
Cup 1	>10.0	2.0913	2.7972	2.9121
Cup 2	5.5 to 10.0	0.0069	0.0249	0.0206
Cup 3	2.4 to 5.5	0.0027	0.0103	0.0075
Cup 4	1.61 to 2.4	0.0012	0.0037	0.0033
Cup 5	0.307 to 1.61	0.0009	0.0026	0.0025
Final filter	<0.307	0.0009	0.0030	0.0026
Total mass of collected test item		3.16	3.03	2.99

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	0.0126	0.0445	0.0365	0.398	1.47	1.22
<5.5	0.0057	0.0196	0.0159	0.180	0.647	0.532
<2.4	0.0030	0.0093	0.0084	0.095	0.307	0.281
<1.61	0.0018	0.0056	0.0051	0.057	0.185	0.171
<0.307	0.0009	0.0030	0.0026	0.028	0.099	0.087

Mean cumulative percentage with a particle size less than 10.0 µm: ≤ 1.47

Mean cumulative percentage with a particle size less than 5.5 µm: ≤ 0.647

Conclusions:

Particle size data acquired for the test item is:
Percentage of test item with an inhalable particle size <100 µm (sieve method): 96.3 %
Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor):≤ 1.47 %
Percentage of test item with a respirable particle size <5.5 µm (cascade impactor): ≤ 0.647 %

Executive summary:

Particle Size Distribution. Particle size data was acquired, 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). The results are as follows:

Percentage of test item with an inhalable particle size <100 µm (sieve method): 96.3 %

Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor): ≤ 1.47 %

Percentage of test item with a respirable particle size <5.5 µm (cascade impactor): ≤ 0.647 %

Description of key information

Particle Size Distribution. 

Percentage of test item with an inhalable particle size <100 µm (sieve method): 96.3 %

Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor): ≤ 1.47 %

Percentage of test item with a respirable particle size <5.5 µm (cascade impactor): ≤ 0.647 %

Additional information

Percentage of test item with an inhalable particle size <100 µm (sieve method): 96.3 %

Percentage of test item with a thoracic particle size <10.0 µm (cascade impactor): ≤ 1.47 %

Percentage of test item with a respirable particle size <5.5 µm (cascade impactor): ≤ 0.647 %