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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From April 27th to April 29th, 2016.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
According to OECD 110 and CIPAC MT 187 (ISO13320-1), with GLP.
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
according to
Guideline:
other: ISO 13320-1
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Percentile:
D10
Mean:
0.53 µm
St. dev.:
0.008
Key result
Percentile:
D50
Mean:
7.45 µm
St. dev.:
0.062
Percentile:
D90
Mean:
51.59 µm
St. dev.:
0.993
Key result
Percentile:
other: Mean (D4,3)
Mean:
17.24 µm
St. dev.:
0.35
No.:
#1
Size:
< 2 µm
Distribution:
21.2 %
No.:
#2
Size:
< 5 µm
Distribution:
39.64 %
No.:
#3
Size:
< 10 µm
Distribution:
56.96 %
No.:
#4
Size:
< 20 µm
Distribution:
70.76 %

Table no. 4. Results of particle size distribution

Size

Test number and fraction size [%]

1

2

3

4

5

Average

less than2 µm

21.1

21.2

21.2

21.3

21.2

21.20

less than 5µm

39.4

39.5

39.6

39.8

39.9

39.64

less than10 µm

56.8

56.8

56.9

57.1

57.2

56.96

less than20 µm

70.4

70.5

70.7

71.0

71.2

70.76

[µm]

d10

0.54

0.54

0.53

0.53

0.52

0.53

d50

7.51

7.50

7.47

7.40

7.37

7.45

d90

52.80

52.20

51.70

50.95

50.29

51.59

*d4,3, [µm]

17.60

17.43

17.26

16.98

16.82

17.24

Average d43,[µm]

17.24

Standard deviation,[µm]

0.35

Relative Standard Deviation,[%]

2.03

*Average d43, [µm] – The mass moment mean (De Brouckere Mean Diameter)

 

 

Conclusions:
The average particle size for the test item is 17.24 µm; the mass median diameter is 7.45 µm.
Executive summary:

The particle size distribution for the test substance was determined according to OECD 100 / CIPAC MT 187 - Particle size analysis by laser diffraction (ISO 13320 -1) under GLP conditions. The average particle size for the test item is 17.24 µm; the mass median diameter is 7.45 µm.

Description of key information

Key study: Test method according to OECD 100 and CIPAC MT187 under GLP conditions. The average particle size for the test item is 17.24 µm; the mass median diameter is 7.45 µm.

Additional information

Key study: The particle size distribution for theobromine was determined according to OECD 100 and CIPAC MT 187 - Particle size analysis by laser diffraction (ISO 13320 -1) under GLP conditions. The average particle size for the test item is 17.24 µm; the mass median diameter is 7.45 µm.