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Particle size distribution (Granulometry)

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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:
reference to same study
Reason / purpose:
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 %

No remarks

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:
reference to same study
Reason / purpose:
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 %

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

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:
reference to same study
Reason / purpose:
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

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

 

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:
reference to same study
Reason / purpose:
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.

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

 

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.

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)