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EC number: 204-327-1 | CAS number: 119-47-1
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:
- weight of evidence
- Study period:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The particle size distribution of Ralox 46 ZF (chemically equivalent to Vulkanox) was determined experimentally without indication of the guideline and method used, hence the results are reliable with restrictions.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- The particle size distribution was indicated in micrometer related to per cent by weight. No details on materials and methods used are provided.
- GLP compliance:
- not specified
- Type of distribution:
- other: per cent by weight
- Percentile:
- D50
- Mean:
- 23 µm
- Remarks on result:
- other: no source field for standard deviation
- No.:
- #1
- Size:
- < 20 µm
- Distribution:
- 40 %
- No.:
- #2
- Size:
- < 32 µm
- Distribution:
- 79 %
- No.:
- #3
- Size:
- < 63 µm
- Distribution:
- 100 %
- Conclusions:
- The mean particle size of Ralox 46 ZF is 23 micrometer.
- Executive summary:
The particle size of Ralox 46 ZF is determined twice and the mean particle size is 23 micrometer.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The particle size distribution of DBMC was determined experimentally according to an in-house method from Chemtura. As it is not indicated which guideline was followed, the results are reliable with restrictions.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- The particle size distribution of DBMC was determined by a dry sieve analysis according to the in-house method no.: 01900 from Chemtura.
- GLP compliance:
- no
- Type of distribution:
- volumetric distribution
- No.:
- #1
- Size:
- < 25 µm
- Distribution:
- ca. 20 %
- No.:
- #2
- Size:
- > 25 - < 45 µm
- Distribution:
- ca. 75 %
- No.:
- #3
- Size:
- > 45 - < 63 µm
- Distribution:
- ca. 2.8 %
- No.:
- #4
- Size:
- > 63 - < 150 µm
- Distribution:
- ca. 1.9 %
- No.:
- #5
- Size:
- > 150 µm
- Distribution:
- ca. 0.3 %
- Conclusions:
- For the non-milled DBMC, 72.5 % of the material possess a particle size > 45 micrometer, for the milled DBMC, 75.0 % of the material possess a particle size of 25 - 45 micrometer and 20.0 % a particle size of < 25 micrometer.
- Executive summary:
The particle size distribution was experimentally determined for two test batches of DBMC, i. e. a non-milled and a milled test material. For the non-milled DBMC, 72.5 % of the material possess a particle size > 45 micrometer, for the milled DBMC, 75.0 % of the material possess a particle size of 25 - 45 micrometer and 20.0 % a particle size of < 25 micrometer.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out according to a SOP of H. C. Starck testing laboratory using IONOL 46 as test material. The guideline used is not indicated in the study report.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- The grain size distribution of IONOL 46 was determined three times with the instrument Mastersizer 2000 Ver. 5.22 (type of measurement: laser diffraction). The guideline followed is not indicated in the study report.
- GLP compliance:
- not specified
- Type of distribution:
- volumetric distribution
- Percentile:
- D10
- Mean:
- 0.86 µm
- St. dev.:
- 0.01
- Percentile:
- D50
- Mean:
- 5.91 µm
- St. dev.:
- 0.17
- Percentile:
- D90
- Mean:
- 14.94 µm
- St. dev.:
- 0.08
- Conclusions:
- The mean particle size of IONOL 46 is approximately 6 micrometer.
- Executive summary:
The particle size of IONOL 46 is determined threefold at different percentile levels. The experimental results indicate that the mean particle size is approximately 6 micrometer.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The particle size distribution of Vulkanox BKF is determined without indication of the method or guideline used, thus the results are reliable with restrictions.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- The guideline used is not indicated, the particle size distribution was determined with a COULTER LS particle size measuring apparatus.
- GLP compliance:
- not specified
- Type of distribution:
- volumetric distribution
- Percentile:
- D10
- Mean:
- 0.68 µm
- Remarks on result:
- other: No source field for Standard deviation.
- Percentile:
- D50
- Mean:
- 15.41 µm
- Remarks on result:
- other: No source field for Standard deviation.
- Percentile:
- D90
- Mean:
- 49.49 µm
- Remarks on result:
- other: No source field for Standard deviation.
- Conclusions:
- The mean particle size of Vulkanox BKF powdered is 15.41 micrometer.
- Executive summary:
The particle size of Vulkanox BKF is determined threefold and the experimental results indicate that the mean particle size is 15.41 micrometer.
Referenceopen allclose all
No remarks
For the non-milled substance batch, Lot W225F0054, the following particle size distribution was obtained:
% |
µm |
23.6 |
< 25 |
3.9 |
25 – 45 |
33.9 |
45 – 63 |
26.6 |
63 – 150 |
12.0 |
> 150 |
For the milled substance batch, Lot W225K0019, the following particle size distribution was obtained:
% |
µm |
20.0 |
< 25 |
75.0 |
25 – 45 |
2.8 |
45 – 63 |
1.9 |
63 – 150 |
0.3 |
> 150 |
Measured values for the particle size distribution at different passages:
a) Measurement 748871/0 IONOL 46, Partie: 02100060/016
Volumetric diameter D |
Particle size [micrometer] |
D(0.05) |
0.55 |
D(0.10) |
0.88 |
D(0.15) |
1.39 |
D(0.20) |
2.05 |
D(0.25) |
2.69 |
D(0.30) |
3.30 |
D(0.35) |
3.88 |
D(0.40) |
4.46 |
D(0.45) |
5.06 |
D(0.50) |
5.69 |
D(0.55) |
6.36 |
D(0.60) |
7.10 |
D(0.65) |
7.91 |
D(0.70) |
8.84 |
D(0.75) |
9.91 |
D(0.80) |
11.21 |
D(0.85) |
12.83 |
D(0.90) |
15.03 |
D(0.95) |
18.45 |
D(0.98) |
22.12 |
b) Measurement 748872/0 IONOL 46, Partie: 02100060/17
Volumetric diameter D |
Particle size [micrometer] |
D(0.05) |
0.54 |
D(0.10) |
0.84 |
D(0.15) |
1.30 |
D(0.20) |
2.03 |
D(0.25) |
2.80 |
D(0.30) |
3.49 |
D(0.35) |
4.11 |
D(0.40) |
4.72 |
D(0.45) |
5.33 |
D(0.50) |
5.95 |
D(0.55) |
6.62 |
D(0.60) |
7.33 |
D(0.65) |
8.12 |
D(0.70) |
9.01 |
D(0.75) |
10.03 |
D(0.80) |
11.25 |
D(0.85) |
12.78 |
D(0.90) |
14.84 |
D(0.95) |
18.02 |
D(0.98) |
21.40 |
c) Measurement 748873/0 IONOL 46, Partie: 02100060/18
Volumetric diameter D |
Particle size [micrometer] |
D(0.05) |
0.54 |
D(0.10) |
0.85 |
D(0.15) |
1.34 |
D(0.20) |
2.15 |
D(0.25) |
2.95 |
D(0.30) |
3.64 |
D(0.35) |
4.26 |
D(0.40) |
4.86 |
D(0.45) |
5.46 |
D(0.50) |
6.09 |
D(0.55) |
6.75 |
D(0.60) |
7.46 |
D(0.65) |
8.24 |
D(0.70) |
9.12 |
D(0.75) |
10.14 |
D(0.80) |
11.36 |
D(0.85) |
12.89 |
D(0.90) |
14.94 |
D(0.95) |
18.12 |
D(0.98) |
21.49 |
The following particle sizes were determined for the test substance Vulkanox BKF powdered:
% < |
micrometer |
10 |
0.680 |
25 |
5.883 |
50 |
15.41 |
75 |
29.95 |
90 |
49.49 |
Description of key information
Weight-of-evidence:
Vulkanox BKF (Lanxess): mean particle size 15.41 µm (SALTIGO, 2008), ca. 40% of particles < 10 µm
Ralox 46 ZF (Raschig): mean particle size 23 µm (BIA, 1993), no information on % particles < 10 µm, 40 % < 20 µm
IONOL 46 (Raschig): mean particle size 6 µm (Starck, 2010), ca. 75% of particles < 10 µm
Lowinox22M46 (Chemtura): information on mean particle size and % particles < 10 µm is not provided; 20 – 23.6 % of particles < 25 µm
Additional information
Up to 75 % of particles < 10 µm(particles below 10 µm are known to bear an inhalation risk of the test substance)
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