α-phenyl-1H-benzimidazole-2-methanol

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:

07 June 2018 to 10 July 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of Inspection: 18 July 2017 - 20 July 2017 Date on Certfiicate: 28 November 2017

Type of method:

cascade impaction

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Remarks on result:

not measured/tested

Remarks:

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

No.:

#1

Size:

< 100 µm

Distribution:

60.5 %

No.:

#2

Size:

< 10 µm

Distribution:

1.48 %

No.:

#3

Size:

< 5.5 µm

Distribution:

0.11 %

Sieve Screening Test

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

Table 2

Measurement	Result
Mass of test item transferred to sieve (W1)	15.12
Mass of test item passed through sieve (W3– W2)	9.14
Percentage of test item less than 100 µm	60.5%

Cascade Impactor

The results of the cascade impactor procedure are shown in the following table:

Table 3

Collection Stage	Particle Size Range Collected (µm)	Collected Mass (g)
		Determination 1	Determination 2	Determination 3
Artificial Throat	n/a	0.35	0.28	0.44
Sample Cup 1	>10.0	2.6174	2.7692	2.5517
Sample Cup 2	5.5 to 10.0	0.0665	0.0300	0.0285
Sample Cup 3	2.4 to 5.5	0.0044	0.0003	0.0026
Sample Cup 4	1.61 to 2.4	0.0000	0.0000	0.0000
Sample Cup 5	0.307 to 1.61	0.0000	0.0000	0.0001
Final Filter	<0.307	0.0013	0.0005	0.0008
Total mass of collected test item		3.0396	3.0800	3.0287
Mass of test item added		3.1138	3.1174	3.0661

The cumulative amounts of test item collected in the three determinations for the individual particle size cut-points are shown in the following table.

Table 4

Particle Size Cut Points (µm)	Cumulative Mass (g)			Cumulative Percentage (%)
	Determination 1	Determination 2	Determination 3	Determination 1	Determination 2	Determination 3
<10.0	0.0722	0.0308	0.0320	2.38	1.00	1.06
<5.5	0.0057	0.0008	0.0035	0.19	0.03	0.12
<2.4	0.0013	0.0005	0.0009	0.04	0.02	0.03
<1.61	0.0013	0.0005	0.0009	0.04	0.02	0.03
<0.307	0.0013	0.0005	0.0008	0.04	0.02	0.03

Mean cumulative percentage with a particle size less than 10.0 μm : 1.48

Mean cumulative percentage with a particle size less than 5.5 μm : 0.11

Discussion

Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes, allowed to stand for 2 minutes and then sampled from the top, middle and bottom.

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Conclusions:

60.5% of the test item was determined to have an inhalable particle size <100µm, 1.48% of the test item was determined to have a thoracic particle size <10.0µm and 0.11% of the test item was determined to have a respirable particle size <5.5µm.

Executive summary:

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:

Measurement	Method	Result
Proportion of test item having an inhalable particle size <100 µm	Sieve	60.5%
Proportion of test item having a thoracic particle size <10.0 µm	Cascade Impactor	1.48%
Proportion of test item having a thoracic particle size <5.5 µm	Cascade Impactor	0.11%

Description of key information

60.5% of the test item was determined to have an inhalable particle size <100µm, 1.48% of the test item was determined to have a thoracic particle size <10.0µm  and 0.11% of the test item was determined to have a respirable particle size <5.5µm.

Additional information

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:

Measurement	Method	Result
Proportion of test item having an inhalable particle size <100 µm	Sieve	60.5%
Proportion of test item having a thoracic particle size <10.0 µm	Cascade Impactor	1.48%
Proportion of test item having a thoracic particle size <5.5 µm	Cascade Impactor	0.11%