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
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Principles of method if other than guideline:
- Principle of test: laser diffraction to measure particle size distribution
- Apparatus: Malvern Mastersizer 2000; Unit: Scirocco 2000
- Parameters analysed / observed: particle size distribution
GLP compliance:
not specified
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Batch: Lot 13-08-01g
date of expiry: 04-10-2026

Results and discussion

Particle sizeopen allclose all
Percentile:
D10
Mean:
35 µm
St. dev.:
1.4
Percentile:
D50
Mean:
281.4 µm
St. dev.:
36.6
Percentile:
D90
Mean:
790.6 µm
St. dev.:
147.4

Applicant's summary and conclusion

Conclusions:
Particle size distribution of the substance is the following: D10 = 35 μm; D50 = 281.4 μm; D90 = 790.6 μm.
Executive summary:

Particle size distribution of the test item was determined by laser diffraction method. Distribution was the following: D10 = 35 μm; D50 = 281.4 μm; D90 = 790.6 μm.