2-[(octadecylcarbamoyl)oxy]ethyl acrylate

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:

2016

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 distribution:

mass based distribution

Specific details on test material used for the study:

Appearance/Physical state: White solid
Purity: >98%
Storage conditions: Room temperature in the dark

No.:

#1

Size:

< 100 µm

Distribution:

13.5 %

No.:

#2

Size:

< 10 µm

Distribution:

< 1 %

No.:

#3

Size:

< 5.5 µm

Distribution:

< 0.8 %

Sieve Screening Test

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

Measurement	Result
Mass of test item transferred to sieve	11.58 g
Mass of test item passed through sieve	1.56 g
Percentage of test item less than 100 µm	13.5 %

 

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	0.43	0.53	0.32
Cup 1	>10.0	2.3304	2.3674	2.6860
Cup 2	5.5 to 10.0	<0.0050	<0.0050	<0.0050
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		2.7614	2.9019	3.0087
Mass of test item added		2.9137	2.9198	3.0470

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 (%)
	Determination 1	Determination 2	Determination 3	Determination 1	Determination 2	Determination 3
<10.0	<0.0250	<0.0250	<0.0250	<1.0	<1.0	<1.0
<5.5	<0.0200	<0.0200	<0.0200	<0.8	<0.8	<0.8
<2.4	<0.0150	<0.0150	<0.0150	<0.6	<0.6	<0.6
<1.61	<0.0100	<0.0100	<0.0100	<0.4	<0.4	<0.4
<0.307	<0.0050	<0.0050	<0.0050	<0.2	<0.2	<0.2

Mean cumulative percentage with a particle size less than 10.0 µm  : <1.0 %         

Mean cumulative percentage with a particle size less than 5.5 µm    : <0.8%          

Conclusions:

Particle size data acquired for the test item is:
Percentage of test item with an inhalable particle size <100 µm (Sieve method): 13.5%
Percentage of test item with a thoracic particle size <10.0 µm (Cascade impactor method): <1.0%
Percentage of test item with a respirable particle size <5.5 µm (Cascade impactor method) <0.8%

Description of key information

In an European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002) study, under GLP conditions, the particle size of 2-Propenoic acid, 2‑[[(octadecylamino)carbonyl]oxy]ethyl ester is <100 µm (Sieve method): 13.5%, <10.0 µm (Cascade impactor method): <1.0% and <5.5 µm (Cascade impactor method) <0.8% (Envigo, 2016a).