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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:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Company data described in detail.
Lower sieve sizes were not considered necessary to demonstrate low dustiness.
Material typically manufactured and supplied in water
Hydrated material was used as impossible to remove all water
Qualifier:
no guideline followed
Principles of method if other than guideline:
Apparatus
Sieves of 250 and 63 µm
The sample was dried prior to testing

4.2 Analytical balance.



5. Procedure

5.1 Stack the sieves and place on the top sieve a weigh of the substance or material to be
tested.

5.2 Shake the sieves with a left to right motion for 5 minutes.

5.3 Weigh the material retained on each sieve to 2 decimal places



6. Calculation

6.1 The weight retained on each sieve if expressed as a % of the total initial weight of the substance being tested.


7. Report

7.1 Report each fraction retained by each sieve expressed as % of the total +/-
2 x SD.
GLP compliance:
no
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Batch number of test material: D-02-4057

Mass median aerodynamic diameter:
> 250 µm
Key result
Percentile:
D50
Mean:
> 250 µm
Remarks on result:
other: Statistical analysis not applied

The substance was dried at 60 °C for 24 hours. The amount of substance used for this particular test was = 25.00 g. As it can be observed, the most important part of the quantity used for this test has a particle size which demonstrates that the dried product can be categorized as a granular substance.

-      Retained by 250 µm = 99.80%

-      Retained by 63 µm = 0.10%

-      < 63 µm =0.10%

 
Conclusions:
< 0.1% w/w passed through a 63 µm seive.
The substance was dried at 60 °C for 24 hours. The amount of substance used for this particular test was = 25.00 g. As it can be observed, the most important part of the quantity used for this test has a particle size which demonstrates that the dried product can be categorized as a granular substance.

- Retained by 250 µm = 99.80%
- Retained by 63 µm = 0.10%
- < 63 µm =0.10%
Executive summary:

The amount by weight of particles of less than 63 microns (dust) was 0.1 %. The most important part of the quantity used for this test (99.8%) has a particle size of >63 µm, which means the dried product, is composed mainly of granules (clear crystals).

An assessment of the dust content was made on the basis of particles passing through a 63 micron sieve.

Description of key information

The substance was dried at 60 °C for 24 hours. The amount of substance used for this particular test was = 22.00 g. As it can be observed, the most important part of the quantity used for this test has a particle size which demonstrates that the dried product can be categorized as a granular substance.

 

 

-      Retained by 250 µm = 14.82%

-      Retained by 63 µm = 57.32%

-      < 63 µm = 27.86%

Additional information