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EC number: 248-383-5 | CAS number: 27277-00-5
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out in a laboratory accredited under GLP, however the study itself was not subject to GLP audit. The study was designed to be compatible with European Commission Guidance Document EUR 20268 (2002).
- 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
- Principles of method if other than guideline:
- By sieve analysis, the percentage of test item having an inhalable particle size of less than 100 μm was determined. By cascade impactor analysis (artificial throat), the percentage of test item having a thoracic particle size of less than 10.0 μm and respirable particle size of less than 5.5 μm was determined.
- GLP compliance:
- no
- Type of method:
- other: Sieve analysis and cascade impactor analysis
- Type of distribution:
- other: inhalable and thoracic fractions
- Remarks on result:
- not determinable
- Remarks:
- See 'Overall remarks'
- Percentile:
- other: 16.2%
- Mean:
- < 100 µm
- Remarks on result:
- other: inhalable particle size
- Percentile:
- other: 6.8%
- Mean:
- < 10 µm
- Remarks on result:
- other: thoracic particle size
- Percentile:
- other: 2.1%
- Mean:
- < 5.5 µm
- Remarks on result:
- other: respirable particle size
- Percentile:
- D50
- Remarks on result:
- not determinable
- Remarks:
- See 'Overall remarks'
- Conclusions:
- The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 16.2 %. The percentage of test item having a thoracic particle size of less than 10.0 μm and respirable particle size of less than 5.5 μm is 6.8 % and 2.1 % respectively.
- Executive summary:
To determine the particle size distribution of the test item a study was performed accoring to European Commission Guidance Document EUR 20268 (2002). By sieve analysis, the percentage of test item having an inhalable particle size of less than 100 μm was determined to be 16.2 %. By cascade impactor analysis, the percentage of test item having a thoracic particle size of less than 10.0 μm and respirable particle size of less than 5.5 μm was determined to be 6.8 % and 2.1 % respectively.
Reference
Sieve analysis results
Measurement |
Result |
Mass of test item transferred to sieve |
11.64 g |
Mass of test item passed through sieve |
1.89 g |
Percentage of test item less than 100μm |
16.2% |
Cascade impactor collected masses
Collection stage |
Particle size range Collected (µm) |
Collected mass (g) |
||
Run 1 |
Run 2 |
Run 3 |
||
Artificial throat |
n/a |
0.19 |
0.34 |
0.19 |
Cup 1 |
>10.0 |
2.6542 |
2.3719 |
2.5778 |
Cup 2 |
5.5 to 10.0 |
0.1220 |
0.1402 |
0.1592 |
Cup 3 |
2.4 to 5.5 |
0.0225 |
0.0210 |
0.0179 |
Cup 4 |
1.61 to 2.4 |
0.0076 |
0.0105 |
0.0092 |
Cup 5 |
0.307 to 1.61 |
0.0062 |
0.0088 |
0.0072 |
Final filter |
<0.307 |
0.0155 |
0.0311 |
0.0266 |
Total mass of collected item |
3.0180 |
2.9235 |
2.9879 |
|
Cascade impactor calculated results
Particle size cut points (µm) |
Cumulative mass (g) |
Cumulative percentage (%) |
||||
Run 1 |
Run 2 |
Run 3 |
Run 1 |
Run 2 |
Run 3 |
|
<10.0 |
0.1738 |
0.2116 |
0.2201 |
5.76 |
7.24 |
7.37 |
<5.5 |
0..0518 |
0.0714 |
0.0609 |
1.72 |
2.44 |
2.04 |
<2.4 |
0.0293 |
0.0504 |
0.0430 |
0.97 |
1.72 |
1.44 |
<1.61 |
0.0217 |
0.0399 |
0.0338 |
0.72 |
1.37 |
1.13 |
<0.307 |
0.0155 |
0.0311 |
0.0266 |
0.51 |
1.06 |
0.89 |
Mean cumulative percentage with a particle size less than 10.0 μm : 6.8%
Mean cumulative percentage with a particle size less than 5.5 μm : 2.1%
Description of key information
16.2% less than 100 µm, EUR 20268, Sieve analysis and cascade impactor analysis, O'Connor 2015
Additional information
The percentage of test item having an inhalable particle size of less than 100 µm was determined to be 16.2%. The percentage of test item having a thoracic particle size of less than 10.0 µm and respirable particle size of less than 5.5 µm is 6.8% and 2.1% respectively.
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