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EC number: 274-499-0 | CAS number: 70247-70-0
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:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008 (as amended) of 30 May 2008.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- sieving
- Remarks:
- Along with Cascade Impactor method
- Type of distribution:
- mass based distribution
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: MC-20/2014 (China)
- Expiration date of the lot/batch: 28 October 2019
- Storage conditions: Frozen in the dark - Mass median aerodynamic diameter:
- > 10 µm
- Percentile:
- D50
- Mean:
- > 10 µm
- Remarks on result:
- other: 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:
- 95.9 %
- Remarks on result:
- other: Percentage of test item with an inhalable particle size <100 μm
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- 0.27 %
- Remarks on result:
- other: Percentage of test item with a thoracic particle size <10.0 μm
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- 0.17 %
- Remarks on result:
- other: Percentage of test item with a respirable particle size <5.5 μm
- Conclusions:
- Particle size data acquired for the test item is as follows:
Percentage with an inhalable particle size <100 µm (Sieve Method): 95.9 %
Percentage with a thoracic particle size <10.0 µm (Cascade Impactor): 0.27 %
Percentage with a respirable particle size <5.5 µm (Cascade Impactor): 0.17 % - Executive summary:
The particle size distribution of FAT 40061/F was according to European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002). The study included a screening test which was performed using a sieving apparatus with a 100 µm stainless steel mesh used as sieve to find out the the percentage of test item with a particle size less than 100 µm. In the second stage, cascade impactor was used to find out the percentage of test with a particle size range of nominally 0.3 to 10 µm. Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes 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.
Particle size data acquired for the FAT 40067/F is:
Percentage with an inhalable particle size <100 µm (Sieve Method): 95.9 %
Percentage with a thoracic particle size <10.0 µm (Cascade Impactor): 0.27 %
Percentage with a respirable particle size <5.5 µm (Cascade Impactor): 0.17 %
Reference
The results of the sieving procedure are shown in the following table:
Measurement |
Result |
Mass of test item transferred to sieve |
10.1 g |
Mass of test item passed through sieve |
9.7 g |
Percentage of test item less than 100 µm |
95.9 % |
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 |
0.45 |
0.32 |
0.25 |
Cup 1 |
>10.0 |
2.5985 |
2.7823 |
2.7263 |
Cup 2 |
5.5 to 10.0 |
0.0035 |
0.0037 |
0.0019 |
Cup 3 |
2.4 to 5.5 |
0.0041 |
0.0011 |
0.0000 |
Cup 4 |
1.61 to 2.4 |
0.0032 |
0.0000 |
0.0000 |
Cup 5 |
0.307 to 1.61 |
0.0015 |
0.0003 |
0.0000 |
Final Filter |
<0.307 |
0.0052 |
0.0005 |
0.0000 |
Total mass of collected test item |
3.0660 |
3.1079 |
2.9782 |
|
Mass of test item added |
3.0782 |
3.0696 |
2.9661 |
|
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 |
0.0175 |
0.0056 |
0.0019 |
0.57 |
0.18 |
0.064 |
<5.5 |
0.0140 |
0.0019 |
0.0000 |
0.46 |
0.06 |
0.00 |
<2.4 |
0.0099 |
0.0008 |
0.0000 |
0.32 |
0.03 |
0.00 |
<1.61 |
0.0067 |
0.0008 |
0.0000 |
0.22 |
0.03 |
0.00 |
<0.307 |
0.0052 |
0.0005 |
0.0000 |
0.17 |
0.02 |
0.00 |
Mean cumulative percentage with a particle size less than 10.0 µm: 0.27%
Mean cumulative percentage with a particle size less than 5.5 µm: 0.17%
Description of key information
Particle size data acquired for the FAT 40067/F was determined as follows:
Percentage with an inhalable particle size <100 µm (Sieve Method): 95.9 %
Percentage with a thoracic particle size <10.0 µm (Cascade Impactor): 0.27 %
Percentage with a respirable particle size <5.5 µm (Cascade Impactor): 0.17 %
Additional information
The particle size distribution of FAT 40061/F was determined according to European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002). The study included a screening test which was performed using a sieving apparatus with a 100 µm stainless steel mesh used as sieve to find out the percentage of test item with a particle size less than 100 µm. In the second stage, cascade impactor was used to find out the percentage of test with a particle size range of nominally 0.3 to 10 µm. Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes 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.
Particle size data acquired for the FAT 40067/F is:
Percentage with an inhalable particle size <100 µm (Sieve Method): 95.9 %
Percentage with a thoracic particle size <10.0 µm (Cascade Impactor): 0.27 %
Percentage with a respirable particle size <5.5 µm (Cascade Impactor): 0.17 %
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