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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:
06 Dec 2018 to 18 Dec 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”
Version / remarks:
Handbook K, 2007
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
agglomerate
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
Appearance: White crystals
EC number: 214-507-1
CAS number: 1137-42-4
Purity: 99.72%
Test item storage: At room temperature, desiccated
Relative density: 1.30 (supplied by Charles River Laboratories)
Mass median aerodynamic diameter:
73 µm
Geometric standard deviation:
2.747
Key result
Percentile:
other: Volume Weighted Mean
Mean:
83.7 µm
Remarks on result:
other: VWM
Remarks:
Using the identified parameters, the particle size was analysed over the range 0.01 µm to 3500 µm.
Key result
Percentile:
other: Mode
Mean:
101 µm
Remarks on result:
other: Mode
Remarks:
Using the identified parameters, the particle size was analysed over the range 0.01 µm to 3500 µm.
Key result
Percentile:
D10
Mean:
13.2 µm
St. dev.:
0.194
Key result
Percentile:
D50
Mean:
64 µm
St. dev.:
1.26
Key result
Percentile:
D90
Mean:
185 µm
St. dev.:
4.86

During the method development phase of the analysis trials were conducted using both the dry powder module and the small volume (wet) module. The small volume module trials were conducted using silicone oil as the dispersant. The small volume module trials did not give reproducible results and the dry powder module was therefore used in the final analysis. The results of the trials indicated that the most appropriate test and material parameters to obtain the optimum measurements were:

Module : Dry powder module

Dispersant : Air

Dispersion pressure : 0.0 barg

Refractive index (sample) : 1.500 n

Absorption : 0.010 AU

Analysis Model : General Purpose

Using the identified parameters, the particle size was analysed over the range 0.01 µm to 3500 µm. The results of the formal analysis are presented in Table 9:1. In addition, a graph of volume (%) versus Particle Diameter (µm), and full particle size distribution, is provided in Graph 9.A (Average of 5 runs).

The full table of results can be found attached below.

Conclusions:
The D50 of this substance was shown to be 64 µm.
Executive summary:

In this guideline study, performed with GLP certification, the test item 4 -hydroxybenzophenone was shown to have a particle size distribution D50 of 64 µm.

Description of key information

Study conducted to recognised testing guidelines with GLP certification.

Additional information