Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

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:
other: Full study report conducted in compliance with GLP, including a GLP statement and certificate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: DIN 53734
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of distribution:
other: Air jet sieve method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: white solid
- Purity test date: Not stated
- Lot/batch No.: A105333
- Expiration date of the lot/batch: Not stated
- Stability under test conditions: Considered stable
- Storage condition of test material: Room temperature
- Other: Container: Clear plastic bag

Results and discussion

Particle size
Percentile:
D50
Mean:
1 - < 45 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all
No.:
#3
Size:
125 µm
Distribution:
70.2 %
No.:
#4
Size:
150 µm
Distribution:
94.2 %
No.:
#5
Size:
250 µm
Distribution:
97.6 %

Applicant's summary and conclusion

Conclusions:
Based on the study data, <1% of the substance has a particle size below 45 microns. 0% of the sample had a particle size below 10 microns.
Executive summary:

The particle size distribution was determined by placing an aliquot of sample on a series of sieves. Air was drawn through the sieves and the sieves weighed at the end of a 5 minute period to determine the weight of sample that pased through the sieve. <1% of the substance had a particle size below 45 microns and 0% had a particle size below 10 microns.