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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:
June 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method. The test substance is adequately characterised. Therefore, full validation applies.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Principles of method if other than guideline:
mechanical sieving
GLP compliance:
no
Type of method:
sieving
Remarks:
By mechanical sieving
Type of particle tested:
other: powder
Type of distribution:
mass based distribution
Specific details on test material used for the study:
8 batches were analyzed. Samples were collected at differents states of the packaging process.
Key result
Percentile:
other: D3
Mean:
< 40 µm
St. dev.:
1.9
Remarks on result:
other: mean of 20 determinations obtained on 8 batches
Key result
Percentile:
other: D17
Mean:
<= 80 µm
St. dev.:
11.1
Remarks on result:
other: mean of 20 determinations obtained on 8 batches
Key result
Percentile:
other: D36
Mean:
<= 100 µm
St. dev.:
8.7
Remarks on result:
other: mean of 20 determinations obtained on 8 batches
Key result
Percentile:
other: D77
Mean:
<= 150 µm
St. dev.:
10.4
Remarks on result:
other: mean of 20 determinations obtained on 8 batches
Key result
Percentile:
other: D92
Mean:
<= 200 µm
St. dev.:
13
Remarks on result:
other: mean of 20 determinations obtained on 8 batches
Key result
Percentile:
other: D97
Mean:
<= 250 µm
St. dev.:
6.3
Remarks on result:
other: mean of 20 determinations obtained on 8 batches

The results of each sample are given in annex II in the report attached.

The table below shows the average distribution for the test item :

Nominal sieve aperture size (µm)

base

40

80

100

150

200

250

Particle size (µm)

< 40

40 - 80

80 - 100

100 - 150

150 - 200

200 - 250

> 250

Percentage of residue (%w/w)

3

14

19

41

15

5

3

Cumulative percentage (%w/w)

3

17

36

77

92

97

100

Conclusions:
The test substance contains particles <100 µm.
Executive summary:

By mechanical sieving, the particle size distribution of the test item was mainly found to range between 40 μm and 200 μm.

64% w/w of particles have a size higher than 100 μm. Among the 35% w/w of particles having a size below 100 μm, 2% w/w have a size below 40 μm (mean of 20 determinations obtained on 8 batches).

89% w/w of particles of the test item have a size between 40 μm and 200 μm.

After tests, it was shown that the particle size distribution of the test item was mainly found from 40 μm to 200 μm.

Description of key information

By mechanical sieving, the particle size distribution of the test item was mainly found to range between 40 μm and 200 μm.

64% w/w of particles have a size higher than 100 μm.

Among the 35% w/w of particles having a size below 100 μm : 2% w/w have a size below 40 μm. (mean of 20 determinations obtained on 8 batches)

89% w/w of particles of the test item have a size between 40 μm and 200 μm.

Additional information