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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:
2013-01-29 to 2013-02-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 59
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of distribution:
mass based distribution
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

The different sieving fractions were as follows:

over        3150µm                 0.00 %

fraction  1400 - 3150 µm    67.78 %

fraction    1000 - 1400µm   14.53 %

fraction      710 - 1000µm    4.55 %

fraction      500 - 710µm     6.06 %

fraction       300 - 500µm     5.63 %

fraction       125 - 300µm     3.64 %

fraction         45 - 125 µm    0.80 %

under                   45µm        0.00 % Most oft the particles had a size between 1400 and 3150 µm. There were no particles smaller than 45 µm. Thus, all particles are larger than the small respirable fraction (< 2 µm).

Conclusions:
Most of the particles had a size between 1400 and 3150 µm. There were no particles smaller than 45 µm. Thus, all particles are larger than the small respirable fraction (< 2 µm).
Executive summary:

The particle size distribution of TC was determined using the dry sieve test in accordance with the guideline CIPAC MT 59. The tested material was sieved using a set of sieves with different size exclusion sizes (45µm, 300 µm, 500 µm, 710 µm, 1000µm,1400 µm and 3150µm). At the end of the sieving procedure for 5 minutes, the content of each sieve was weighed. Two replicates were performed and the result was given as an average of these two. Most of the particles had a size between 1400 and 3150 µm. There were no particles smaller than 45 µm. Thus, all particles are larger than the small respirable fraction (< 2 µm).

This study is considered not relevant in the evaluation of the marketed substance because the substance is marketed as a wet press cake containing water.

Description of key information

The particle size distribution of 6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid (TC) was determined using the dry sieve test in accordance with the guideline CIPAC MT 59. The tested material was sieved using a set of sieves with different size exclusion sizes (45µm, 300 µm, 500 µm, 710 µm, 1000µm, 1400 µm and 3150µm). At the end of the sieving procedure for 5 minutes, the content of each sieve was weighed. Two replicates were performed and the result was given as an average of these two. Most of the particles had a size between 1400 and 3150 µm. There were no particles smaller than 45 µm. Thus, all particles are larger than the small respirable fraction (< 2 µm).

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