Bis-O-(benzylidene)-D-glucitol

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:

Experimental starting date: 01 June 2017; Experimental completion date: 13 September 2017

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

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Remarks on result:

other: not determined

No.:

#1

Size:

< 100 µm

Distribution:

47.2 %

No.:

#2

Size:

< 10 µm

Distribution:

<= 1.8 %

No.:

#3

Size:

< 5.5 µm

Distribution:

< 0.7 %

Sieve Screening Test:

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

Measurement	Result
Mass of test item transferred to sieve	14.61 g
Mass of test item passed through sieve	6.89 g
Percentage of test item less than 100 µm	47.2 %

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	0.10	0.13	0.14
Cup 1	>10.0	2.9233	2.8442	2.9071
Cup 2	5.5 to 10.0	0.0226	0.0275	0.0361
Cup 3	2.4 to 5.5	<0.0050	<0.0050	<0.0050
Cup 4	1.61 to 2.4	<0.0050	<0.0050	<0.0050
Cup 5	0.307 to 1.61	<0.0050	<0.0050	<0.0050
Final filter	<0.307	<0.0050	<0.0050	<0.0050
Total mass of collected test item[1]		3.0463	3.0035	3.0875
Mass of test item added		3.0637	3.0391	3.1130

[1]Calculated based on actual weight increases as opposed to limit values applied.

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 point (µm)	Cumulative mass (g)			Cumulative percentage (%)
	Det 1	Det 2	Det 3	Det 1	Det 2	Det 3
<10.0	≤0.0426	≤0.0475	≤0.0561	≤1.4	≤1.6	≤1.8
<5.5	<0.0200	<0.0200	<0.0200	<0.7%	<0.7%	<0.6%
<2.4	<0.0150	<0.0150	<0.0150	<0.5%	<0.5%	<0.5%
<1.61	<0.0100	<0.0100	<0.0100	<0.3%	<0.3%	<0.3%
<0.307	<0.0050	<0.0050	<0.0050	<0.2%	<0.2%	<0.2%

Overallcumulative percentage with a particle size less than 10.0 µm:         ≤1.8%

Overall cumulative percentage with a particle size less than 5.5 µm:           <0.7%

Conclusions:

Particle size data acquired for the test item is as follows:
Percentage of test item with an inhalable particle size <100 µm: 47.2%
Percentage of test item with a thoracic particle size <10.0 µm: ≤1.8%
Percentage of test item with a respirable particle size <5.5 µm: <0.7%

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	47.2%
Proportion of test item having a thoracic particle size <10.0 µm	Cascade Impactor	≤1.8%
Proportion of test item having a respirable particle size <5.5 µm	Cascade Impactor	<0.7%

Description of key 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	47.2%
Proportion of test item having a thoracic particle size <10.0 µm	Cascade Impactor	≤1.8%
Proportion of test item having a respirable particle size <5.5 µm	Cascade Impactor	<0.7%