Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

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:
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. certificate)
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).

Additional information