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Physical & Chemical properties

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:
2010-08-03 to 2010-11-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2010-03-22
Type of method:
microscopic examination
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Appearance: solid
Storage conditions: room temperature
Remarks on result:
not measured/tested
No.:
#1
Size:
>= 105 - <= 130 µm
Distribution:
0 %
Remarks on result:
other: Mean of six replicates
No.:
#2
Size:
>= 60 - <= 105 µm
Distribution:
0 %
Remarks on result:
other: Mean of six replicates
No.:
#3
Size:
>= 30 - <= 60 µm
Distribution:
0 %
Remarks on result:
other: Mean of six replicates
No.:
#4
Size:
>= 10.4 - <= 30 µm
Distribution:
69.4 %
Remarks on result:
other: Mean of six replicates
No.:
#5
Size:
>= 0.5 - <= 10.4 µm
Distribution:
30.6 %
Remarks on result:
other: Mean of six replicates

Results
The reported results were prepared from at least fifty fields from each slide. The mean
projected area data were used to calculate spherical particle volumes in each range, which,
when combined with the particle number distribution, gives a volume or mass distribution.
The observed particles were predominantly dark and irregularly shaped.

Description of key information

The observed particles were predominantly dark and irregularly shaped. All particles were smaller than 30 µm, with ca. 70% (w/w) in the range 10.4-30 µm, and 30%(w/w) in the range 0.5-10.4 µm.

Additional information

A particle size distribution determination was performed as part of a set of tests for physico-chemical properties (Huntingdon Life Sciences, 2011, Study FGE0002). The particle size distribution was determined according to OECD Method 110, and the study was conducted in compliance with GLP. An initial sieve analysis was followed by an automated microscopic image analysis.


The observed particles were predominantly dark and irregularly shaped. All particles were smaller than 30 µm, with ca. 70% (w/w) in the range 10.4-30 µm, and 30%(w/w) in the range 0.5-10.4 µm.