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Physical & Chemical properties

Particle size distribution (Granulometry)

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Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-03-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented technique which meets scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Principles of method if other than guideline:
The particle size distribution was analysed by laser diffraction using the instrument Malvern Mastersizer X. Isobutanol was poured into the dispersing unit, and pumped trough the system. It was made sure that no air bubbles were present. A concentrated slurry of the sample in dispersant was made in a beaker with vigorous stirring. Alignment was performed and the background was measured. The sample was added from the slurry into the dispersing unit with a cut-off plastic Pasteur pipette. The sample was adjusted until an acceptable obscuration (15-25%) of the laser beam was obtained.
The dispersion was homogenized after 5 minutes and the particle size distribution was measured
GLP compliance:
no
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Analytical purity: 96% GC purity
- Impurities (identity and concentrations): < 1% pentaerythritol (CAS 115-77-5), < 1% Tri-Pentaerythritol
- Purity test date: 2007-06-06
- Lot/batch No.: 3514035
- Storage condition of test material: room temperature

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
69 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
12 µm
Percentile:
D50
Mean:
69 µm
Percentile:
D90
Mean:
292 µm
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 10 µm
Distribution:
23.9 %
No.:
#2
Size:
< 50 µm
Distribution:
73.2 %
No.:
#3
Size:
< 100 µm
Distribution:
93.2 %

Applicant's summary and conclusion

Conclusions:
93% of Di-Pentaerythritol is in the inhalable fraction (<100 µm)
Executive summary:

93% of Di-Pentaerythritol is in the inhalable fraction (<100 µm)