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EC number: 482-150-0 | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 18 July 2007 and 29 August 2007.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- cascade impaction
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- Magenta T-43
- IUPAC Name:
- Magenta T-43
- Test material form:
- solid: particulate/powder
- Details on test material:
- Sponsor's identification: MAGENTA T-43
Description: dark red solid
Storage conditions: room temperature, in the dark
Lot number: H186-5
Constituent 1
Results and discussion
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- 100 µm
- Distribution:
- 60.5 %
- Remarks on result:
- other: Proportion of test material having an inhalable particle size, sieve method
- No.:
- #2
- Size:
- 10 µm
- Distribution:
- 1.77 %
- Remarks on result:
- other: Proportion of test material having a thoracic particle size, cascade impactor method
- No.:
- #3
- Size:
- 5.5 µm
- Distribution:
- 0.21 %
- Remarks on result:
- other: Proportion of test material having a respirable particle, cascade impactor method
Any other information on results incl. tables
Results
Definitive test (cascade impactor method)
The results of the cascade impactor method were tabulated.
Cascade Impactor: Determination 1
Cup Number |
Particle Size Range Collected (µM) |
Cup Masses (g) |
||
Pre-Sampling |
Post-Sampling |
Difference |
||
1 |
>10.0 |
86.1398 |
89.1390 |
2.9992 |
2 |
5.5-10.0 |
85.4742 |
85.5283 |
0.0541 |
3 |
2.4-5.5 |
85.8849 |
85.8896 |
0.0047 |
4 |
1.61-2.4 |
85.6339 |
85.6346 |
0.0007 |
5 |
0.307-1.61 |
85.7772 |
85.7774 |
0.0002 |
Filter |
<0.307 |
75.1904 |
75.1916 |
0.0012 |
Amount of test material found in artificial throat: 0.03 g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 3.0901 g.
The cumulative amounts found for the individual particle size cut-points (µm) were tabulated.
Particle size cut-points: Determination 1
Cup number |
Particle Size Cut-Points (µm) |
Cumulative Mass of Test Material (g) |
Cumulative Amount of Test Material (%) |
2 |
10.0 |
0.0609 |
1.97 |
3 |
5.5 |
0.0068 |
0.220 |
4 |
2.4 |
0.0021 |
6.80 x 10-2 |
5 |
1.61 |
0.0014 |
4.53 x 10-2 |
Filter |
0.307 |
0.0012 |
3.88 x 10-2 |
Cascade Impactor: Determination 2
The results of the cascade impactor method were tabulated.
Cup Number |
Particle Size Range Collected (µM) |
Cup Masses (g) |
||
Pre-Sampling |
Post-Sampling |
Difference |
||
1 |
>10.0 |
86.1400 |
89.1299 |
2.9899 |
2 |
5.5-10.0 |
85.4741 |
85.5111 |
0.0370 |
3 |
2.4-5.5 |
85.8848 |
85.8884 |
0.0036 |
4 |
1.61-2.4 |
85.6339 |
85.6351 |
0.0012 |
5 |
0.307-1.61 |
85.7770 |
85.7774 |
0.0004 |
Filter |
<0.307 |
75.1877 |
75.1881 |
0.0004 |
Amount of test material found in artificial throat: 0.01 g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 3.0425 g.
The cumulative amounts found for the individual particle size cut-points (µm) were tabulated.
Particle size cut-points: Determination 2
Cup number |
Particle Size Cut-Points (µm) |
Cumulative Mass of Test Material (g) |
Cumulative Amount of Test Material (%) |
2 |
10.0 |
0.0426 |
1.40 |
3 |
5.5 |
0.0056 |
0.184 |
4 |
2.4 |
0.0020 |
6.57 x 10-2 |
5 |
1.61 |
0.0008 |
2.63 x 10-2 |
Filter |
0.307 |
0.0004 |
1.32 x 10-2 |
Cascade Impactor: Determination 3
The results of the cascade impactor method were tabulated.
Cup Number |
Particle Size Range Collected (µM) |
Cup Masses (g) |
||
Pre-Sampling |
Post-Sampling |
Differencei |
||
1 |
>10.0 |
86.1408 |
89.1298 |
2.9890 |
2 |
5.5-10.0 |
85.4746 |
85.5273 |
0.0527 |
3 |
2.4-5.5 |
85.8854 |
85.8893 |
0.0039 |
4 |
1.61-2.4 |
85.6339 |
85.6346 |
0.0007 |
5 |
0.307-1.61 |
85.7775 |
85.7776 |
0.0001 |
Filter |
<0.307 |
75.1845 |
75.1867 |
0.0022 |
Amount of test material found in artificial throat: 0.01 g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 3.0586 g.
The cumulative amounts found for the individual particle size cut-points (µm) were tabulated.
Particle size cut-points: Determination 3
Cup number |
Particle Size Cut-Points (µm) |
Cumulative Mass of Test Material (g) |
Cumulative Amount of Test Material (%) |
2 |
10.0 |
0.0596 |
1.95 |
3 |
5.5 |
0.0069 |
0.226 |
4 |
2.4 |
0.0030 |
9.81 x 10-2 |
5 |
1.61 |
0.0023 |
7.52 x 10-2 |
Filter |
0.307 |
0.0022 |
7.19 x 10-2 |
The overall cumulative amounts of test material with a particle size less than 10.0 µm (%)from Determinations 1 to 3 were tabulated.
Determination |
Cumulative Amount of Test Material Less Than 10.0 µm (%) |
Mean Cumulative Amount of Test Material Less Than 10.0 µm (%) |
1 |
1.97 |
1.77 |
2 |
1.40 |
|
3 |
1.95 |
The overall cumulative amounts of test material with a particle size less than 5.5 µm (%) from Determinations 1 to 3 were tabulated.
Determination |
Cumulative Amount of Test Material Less Than 5.5 µm (%) |
Mean Cumulative Amount of Test Material Less Than 5.5 µm (%) |
1 |
0.220 |
0.210 |
2 |
0.184 |
|
3 |
0.226 |
Concluding Particle Size Data
Measurement |
Method |
Result |
Proportion of test material having an inhalable particle size < 100µm |
Sieve |
60.5% |
Proportion of test material having a thoracic particle size < 10.0 µrn |
Cascade Impactor |
1.77% |
Proportion of test material having a respirable particle size < 5.5 µm |
Cascade Impactor |
0.210% |
Applicant's summary and conclusion
- Conclusions:
- The proportion of test material having an inhalable particle size less than 100 µm = 60.5% by the sieve method.
The proportion of test material having a thoracic particle size less than 10 µm = 1.77% by the cascade impactor method.
The proportion of test material having a respirable particle size less than 5.5 µm = 0.210% by the cascade impactor method.
Mass Median Diameter: Too few particles were of a size less than 10 µm to allow accurate assessment of mass median aerodynamic diameter. - Executive summary:
The particle size distribution of substance Magenta T-43 was determined to have 60.5% inhalable particle size < 100 µm by the sieve method; 1.77 % thoracic particle size < 10 µm by the cascade impactor method and 0.210% respirable particle size < 5.5 µm by the cascade impactor method, according to the OECD Test Guideline 110.
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