Potassium sodium amino-hydroxy-[(3-{[2-(substituted)ethyl]sulfonyl}phenyl)diazenyl]-[(2-sulfonato-4-{[2-(substituted)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-disulfonate

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 23 October 2014 and 01 July 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Principles of method if other than guideline:

As per the above mentioned guideline

GLP compliance:

yes

Type of method:

cascade impaction

Type of distribution:

mass based distribution

Specific details on test material used for the study:

None

Mass median aerodynamic diameter:

other: Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.

Key result

Percentile:

D50

Mean:

other: Can not be determined as too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.

Remarks on result:

other: standard deviation not specified

No.:

#1

Size:

< 100 µm

Distribution:

92.2 %

No.:

#2

Size:

< 10 µm

Distribution:

0.231 %

No.:

#3

Size:

< 5.5 µm

Distribution:

0.161 %

Sieve Screening Test

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

Measurement	Results
Mass of test item transferred to sieve	14.69 g
Mass of test item passed through sieve	13.55 g
Percentage of test item less than 100 µm	92.2 %

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	0.67	0.17	0.41
Cup 1	>10.0	2.3362	2.8224	2.5858
Cup 2	5.5 to 10.0	0.0025	0.0025	0.0013
Cup 3	2.4 to 5.5	0.0020	0.0018	0.0007
Cup 4	1.61 to 2.4	0.0018	0.0016	0.0006
Cup 5	0.307 to 1.61	0.0017	0.0015	0.0007
Final Filter	<0.307	0.0007	0.0008	0.0006
Total mass of collected test item		3.0149	3.0006	2.9997

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	0.0087	0.0082	0.0039	0.289	0.273	0.130
<5.5	0.0062	0.0057	0.0026	0.206	0.190	0.087
<2.4	0.0042	0.0039	0.0019	0.139	0.130	0.063
<1.61	0.0024	0.0023	0.0013	0.080	0.077	0.043
<0.307	0.0007	0.0008	0.0006	0.023	0.027	0.020

Mean cumulative percentage with a particle size less than 10.0 µm: 0.231

Mean cumulative percentage with a particle size less than 5.5 µm: 0.161

Conclusions:

Percentage of test item with an inhalable particle size < 100 µm (sieve method) was 92.2 %
Percentage of test item with a thoracic particle size <10.0 μm (cascade impactor) was 0.231 %
Percentage of test item with a respirable particle size <5.5 μm (cascade impactor) was 0.161 %

Executive summary:

Particle size data was acquired, using a procedure designed to be compatible with European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’, 2002. The results are as follows:

Proportion of test item having an inhalable particle size <100 μm (Sieve) 92.2 %

Proportion of test item having a thoracic particle size <10.0 μm (Cascade Impactor) 0.231 %

Proportion of test item having a respirable particle size <5.5 μm (Cascade Impactor) 0.161 %

Description of key information

Proportion of test item having an inhalable particle size <100 μm (Sieve) 92.2 %
Proportion of test item having a thoracic particle size <10.0 μm (Cascade Impactor) 0.231 %
Proportion of test item having a respirable particle size <5.5 μm (Cascade Impactor) 0.161 %

Additional information

The particle size distribution was assessed using a procedure designed to be compatible with European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’, 2002.

The proportion of test item having an inhalable particle size < 100 μm was 92.2 %.

The proportion of test item having a thoracic particle size < 10 μm was 0.231 %

The proportion of test item having a respirable particle size < 5.5 μm was 0.161 %