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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Key result
Percentile:
D50
Mean:
87.6 µm
Remarks on result:
other: SD not determined
Percentile:
D10
Mean:
14.2 µm
Remarks on result:
other: SD not determined
Percentile:
D90
Mean:
294.8 µm
Remarks on result:
other: SD not determined

The particle size distribution was measured twice and the mean of the two replicates was calculated. The median particle size L50 of the test items deduced from the particle distributions is 87.6 µm. The particle size L10 of the test items deduced from the particle size distributions is 14.2 µm. The particle size L90 of the test items deduced from the particelel size distributions is 294.8 µm.

Conclusions:
The median particle size L50 of the test items deduced from the particle distributions is 87.6 µm.
Executive summary:

Tests on the granulometry of fumaric acid manufactured by DSM, ARKEMA, POLYNT, THIRUMALAI Chemicals Ltd., were carried out according to the same methodology and in the same laboratory in 2010 (GLP studies). The results show consistent distribution of particles. The results presented in this registration dossier are those obtained with the fumaric acid manufactured by DSM. The results on the fumaric acid manufactured by other companies can be obtained upon request at the other registrants.  

The median particle size L50 of the test items deduced from the particle distributions is 87.6 µm.
The particle size L10 of the test items deduced from the particle size distributions is 14.2 µm.
The particle size L90 of the test items deduced from the particle size distributions is 294.8 µm.

Description of key information

The median particle size L50 of fumaric acid deduced from the particle size distribution is 87.6 µm.

Additional information

Tests on the granulometry of fumaric acid manufactured by DSM, ARKEMA, POLYNT, THIRUMALAI Chemicals Ltd., were carried out according to the same methodology and in the same laboratory in 2010 (GLP studies). The results show consistent distribution of particles. The results presented in this registration dossier are those obtained with the fumaric acid manufactured by DSM. The results on the fumaric acid manufactured by other companies can be obtained upon request at the other registrants.  

The median particle size L50 of the test items deduced from the particle distributions is 87.6 µm.
The particle size L10 of the test items deduced from the particle size distributions is 14.2 µm.
The particle size L90 of the test items deduced from the particle size distributions is 294.8 µm.