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EC number: 203-657-3 | CAS number: 109-23-9
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Jun 2018 to 12 Sep 2018
- 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’
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- cascade impaction
- Type of distribution:
- mass based distribution
- Remarks on result:
- not determinable
- Remarks:
- See 'Any other information on results incl. tables'
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- ca. 32.9 %
- Remarks on result:
- other: method: sieve
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- ca. 2.33 %
- Remarks on result:
- other: method: cascade impactor
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- ca. 0.24 %
- Remarks on result:
- other: method: cascade impactor
- Conclusions:
- Percentage of item less than 100 μm: 32.9 %
Mean cumulative percentage with a particle size less than 10.0 μm: 2.33 %
Mean cumulative percentage with a particle size less than 5.5 μm: 0.24 % - Executive summary:
The particle size distribution of test substance was determined using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002). The results of the sieving procedure showed that the percentage of test item which was less than 100 μm was 32.9 % while the Mean cumulative percentage with a particle size less than 10.0 and 5.5 μm was found to be 2.33 % and 0.24 % respectively.
Reference
SIEVE SCREENING TEST
The results of the sieving procedure are shown in the following table:
Measurement |
Result |
Mass of test item transferred to sieve |
10.77 |
Mass of test item passed through sieve |
3.54 |
Percentage of test item less than 100 μm |
32.9 % |
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 |
0.46 |
0.24 |
0.71 |
Sample Cup 1 |
> 10.0 |
2.4668 |
2.6005 |
2.2927 |
Sample Cup 2 |
5.5 to 10.0 |
0.1037 |
0.0610 |
0.0450 |
Sample Cup 3 |
2.4 to 5.5 |
0.0099 |
0.0044 |
0.0038 |
Sample Cup 4 |
1.61 to 2.4 |
0.0015 |
0.0004 |
0.0005 |
Sample Cup 5 |
0.307 to 1.61 |
0 |
0 |
0.0001 |
Final Filter |
< 0.307 |
0.0007 |
0 |
0.0005 |
Total mass of collected test item |
3.0426 |
2.9063 |
3.0526 |
|
Mass of test item added |
3.2235 |
3.0259 |
3.1482 |
|
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 |
0.1158 |
0.0658 |
0.0499 |
3.81 |
2.26 |
1.64 |
< 5.5 |
0.0121 |
0.0048 |
0.0049 |
0.40 |
0.17 |
0.16 |
< 2.4 |
0.0022 |
0.0004 |
0.0011 |
0.07 |
0.01 |
0.04 |
< 1.61 |
0.0007 |
0 |
0.0006 |
0.02 |
0 |
0.02 |
< 0.307 |
0.0007 |
0 |
0.0005 |
0.02 |
0 |
0.02 |
Mean cumulative percentage with a particle size less than 10.0 μm : 2.33 %
Mean cumulative percentage with a particle size less than 5.5 μm : 0.24 %
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. Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter. 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.
Description of key information
according to EC Guidance Document EUR 20268, cascade impaction, Butler 2018
Percentage of item less than 100 μm: 32.9 %
Mean cumulative percentage with a particle size less than 10.0 μm: 2.33 %
Mean cumulative percentage with a particle size less than 5.5 μm: 0.24 %
Additional information
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