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EC number: - | CAS number: -
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:
- Experiment completion date - 19 April 2010; Experiment completion date - 21 April 2010; Study completion date - 31 May 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Europen Commission, Directorate General XII-JRC, Science Research and Development-Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document, ECB/TM/February 1996.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission, Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction”.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Specific details on test material used for the study:
- Identification: FAT 40851/A TE
Batch Number: TZ 5891 / BOP 02-09
Purity: 69.9 % all coloured components
Appearance: Orange powder
Expiry Date: July 31, 2014
Storage Conditions: At room temperature at about 20 °C - Percentile:
- D50
- Mean:
- < 3.3 µm
- St. dev.:
- 0.192
- Remarks on result:
- other: The MMD of the test item indicates that 50 % (by mass) of the particles are smaller than 3.3 μm.
- Size:
- >= 0.3 - < 1 µm
- Distribution:
- >= 11.7 - <= 13.4 %
- Remarks on result:
- other: mean 12.63 ± 0.81 %
- No.:
- #1
- Size:
- >= 0.3 - < 3 µm
- Distribution:
- >= 42.9 - <= 47.8 %
- Remarks on result:
- other: mean 45.60 ± 2.38 %
- No.:
- #2
- Size:
- >= 0.3 - < 4 µm
- Distribution:
- >= 55.7 - <= 62.4 %
- Remarks on result:
- other: PM4, mean value 59.38 ± 3.43 %
- No.:
- #3
- Size:
- >= 0.3 - < 10 µm
- Distribution:
- >= 93.5 - <= 98.9 %
- Remarks on result:
- other: PM10, mean value 96.45 ± 2.81 %
- No.:
- #4
- Size:
- >= 0.3 - < 20 µm
- Distribution:
- >= 100 %
- Remarks on result:
- other: PM100, mean value 100 ± 0.00 %
- Conclusions:
- The mass median diameter (MMD) was determined to be 3.3 μm. The particle size distribution was found to range from approximately 0.3 μm to 20.0 μm.
- Executive summary:
The determination of the particle size distribution of test substance was performed under GLP according to the European Commission, Document ECB/TM/February 1996: ”Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document and the EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction” using the laser diffraction method. The test substance is a powder. Under the microscope (with a magnification of 100), small-sized particles were observed. A solubility test showed, that the test item is both: sparingly soluble and well dispersible in 2- propanol. The particle size distribution of test substance was performed with two samples of the stock dispersion each measured in duplicate. The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary. The mass median diameter (MMD) of test substance was determined to be 3.3 μm. The particle size distribution was found to range from approximately 0.3 μm to 20.0 μm.
Reference
Table 1: Particle Size Distribution of test substance
[%] | Particle Size [µm] | Stand. Dev. | ||||
1st Run | 2nd Run | 3rd Run
| 4th Run
| Mean | ||
5 | <0.54 | <0.56 | <0.50 | <0.50 | <0.5 | 0.027 |
10 | <0.87 | <0.89 | <0.80 | <0.81 | <0.8 | 0.044 |
50 | <3.42 | <3.54 | <3.14 | <3.17 | <3.3* | 0.192 |
90 | <8.42 | <8.77 | <6.91 | <6.89 | <7.7 | 0.987 |
* The MMD of the test item indicates that 50 % (by mass) of the particles are smaller than 3.3 µm
Table 2: Particle Size Distribution of test substance in [%] at the relevant Particle Size
[µm] | 1st Run | 2nd Run | 3rd Run | 4th Run | Mean | Stand. [%] |
<0.3 | ***** | ***** | ***** | ***** |
|
|
<0.5 | 4.30 | 4.10 | 5.00 | 4.90 | 4.58 | 0.44 |
<1.0 | 12.20 | 11.70 | 13.40 | 13.20 | 12.63 | 0.81 |
<2.0 | 29.20 | 28.20 | 31.50 | 31.10 | 30.00 | 1.56 |
<3.0 | 44.30 | 42.90 | 47.80 | 47.40 | 45.60 | 2.38 |
<4.0 | 57.20 | 55.70 | 62.40 | 62.20 | 59.38 | 3.43 |
<5.0 | 68.10 | 66.40 | 74.70 | 74.60 | 70.95 | 4.33 |
<6.0 | 76.70 | 75.00 | 83.90 | 83.90 | 79.88 | 4.70 |
<7.0 | 83.40 | 81.90 | 90.50 | 90.60 | 86.60 | 4.60 |
<8.0 | 88.30 | 86.90 | 94.60 | 94.80 | 91.15 | 4.14 |
<9.0 | 91.90 | 90.70 | 97.20 | 97.40 | 94.30 | 3.50 |
<10.0 | 94.60 | 93.50 | 98.80 | 98.90 | 96.45 | 2.81 |
<20.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<30.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<40.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<50.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<60.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<70.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<80.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<90.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<100.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<125.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<150.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<175.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<200.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<225.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<250.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<275.0 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 0.00 |
<300.0 | ***** | ***** | ***** | ***** |
|
|
Description of key information
The mass median diameter (MMD) of test substance was determined to be 3.3 μm. The particle size distribution was found to range from approximately 0.3 μm to 20.0 μm.
Additional information
The determination of the particle size distribution of test substance was performed under GLP according to the European Commission, Document ECB/TM/February 1996: ”Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document and the European Commission, Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction” using the laser diffraction method. The test substance is a powder. Under the microscope (with a magnification of 100), small-sized particles were observed. A solubility test showed, that the test item is both sparingly soluble and well dispersible in 2-propanol. The particle size distribution of test substance was performed with two samples of the stock dispersion each measured in duplicate. The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary. The mass median diameter (MMD) of test substance was determined to be 3.3 μm. The particle size distribution was found to range from approximately 0.3 μm to 20.0 μm.
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