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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: DIN 66165
GLP compliance:
no
Type of method:
sieving
Type of distribution:
other: diameter
Key result
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:
2.9 %
No.:
#2
Size:
> 125 - <= 500 µm
Distribution:
3.5 %
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:
2.1 %
No.:
#6
Size:
> 2 000 - <= 3 150 µm
Distribution:
5.2 %
No.:
#7
Size:
> 3 150 - <= 4 000 µm
Distribution:
6 %
No.:
#8
Size:
> 4 000 - <= 5 000 µm
Distribution:
9.8 %
No.:
#9
Size:
> 5 000 µm
Distribution:
67.7 %

X10: 1671 µm

X50: > 5000 µm

X90: > 5000 µm

Conclusions:
The mass median diameter (MMD) of the test item was calculated to be > 5000 µm.
Executive summary:

In the non-GLP Klimisch 1 study from Bütfering (2012) the particle size distribution of the test item Reaction products of ricinoleic acid with 2-aminoethanol and maleic acid and sodium hydrogensulfite was determined using the sieving method according to DIN 66165 with sieve sizes ranging from 125 to 5000 µm. The mass median diameter (MMD) of the test item was calculated to be > 5000 µm.

This result is considered relevant and reliable for the risk assessment.

Description of key information

mass median diameter (MMD):  > 5000 µm.

Additional information

In the non-GLP Klimisch 1 key study from Bütfering (2012) the particle size distribution of the test item Reaction products of ricinoleic acid with 2-aminoethanol and maleic acid and sodium hydrogensulfite was determined using the sieving method according to DIN 66165 with sieve sizes ranging from 125 to 5000 µm. The mass median diameter (MMD) of the test item was calculated to be > 5000 µm.

This result is considered relevant and reliable for the risk assessment.