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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:
24 August 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: DIN 66165
GLP compliance:
no
Type of method:
sieving
Type of distribution:
other: diameter
Percentile:
D50
Mean:
> 5 000 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
No.:
#1
Size:
> 125 µm
Distribution:
4.5 %
No.:
#2
Size:
>= 125 - < 500 µm
Distribution:
7.3 %
No.:
#3
Size:
>= 500 - < 1 000 µm
Distribution:
1.7 %
No.:
#4
Size:
>= 1 000 - < 1 400 µm
Distribution:
1 %
No.:
#5
Size:
>= 1 400 - < 2 000 µm
Distribution:
2 %
No.:
#6
Size:
>= 2 000 - < 3 150 µm
Distribution:
4.7 %
No.:
#7
Size:
>= 3 150 - 4 000 µm
Distribution:
9.45 %
No.:
#8
Size:
>= 4 000 - < 5 000 µm
Distribution:
10.89 %
No.:
#9
Size:
> 5 000 µm
Distribution:
68.4 %

X10 : 408 µm

X50 : > 5000 µm

X90 : > 5000 µm

Executive summary:

In the non-GLP Klimisch 1 study from Bütfering (2012) the particle size distribution of Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-18 (even numbered), C18 unsaturated alkyl) tetrasodium salts was determined using sieving method with mesh sizes ranging from 125 to 5000 µm. In total 135.18 g of the test item was sieved through meshes. The mass median diameter (MMD) of the test item is calculated as > 5000 µm.

This study is considered relevant for the risk assessment.

Description of key information

mass median diameter (MMD) :  > 5000 µm

Additional information

In the non-GLP Klimisch 1 study from Bütfering (2012) the particle size distribution of Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-18 (even numbered), C18 unsaturated alkyl) tetrasodium salts was determined using sieving method with mesh sizes ranging from 125 to 5000 µm. In total 135.18 g of the test item was sieved through meshes. The mass median diameter (MMD) of the test item is calculated as > 5000 µm. This study is considered relevant for the risk assessment.