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:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Two samples was measured :
Sample 1 :
FILBAB reference : 1803-136246
SPONSOR reference : Erythritol E5118098 - 06/03/18
Sample 2 :
FILBAB reference : 1803-136247
SPONSOR reference : Erythritol E5118097 - 06/03/18

Results and discussion

Mass median aerodynamic diameter:
ca. 550.5 µm
Geometric standard deviation:
ca. 18
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
ca. 341.2 µm
St. dev.:
0
Remarks on result:
other: no statistical analysis
Key result
Percentile:
D10
Mean:
ca. 334.3 µm
St. dev.:
0
Remarks on result:
other: no statistical analysis
Key result
Percentile:
D50
Mean:
ca. 568.5 µm
St. dev.:
0
Remarks on result:
other: no statistical analysis
Key result
Percentile:
D50
Mean:
ca. 532.5 µm
St. dev.:
0
Remarks on result:
other: no statistical analysis
Key result
Percentile:
D90
Mean:
ca. 815.1 µm
St. dev.:
0
Remarks on result:
other: no statistical analysis
Key result
Percentile:
D90
Mean:
ca. 770.9 µm
St. dev.:
0
Remarks on result:
other: no statistical analysis

Any other information on results incl. tables

Sample 1 :

Distribution monomodale avec un pic large et centré autour de 623 μm

Sample 2 :

Distribution monomodale avec un pic large et centré autour de 567 μm

Applicant's summary and conclusion

Conclusions:
The test item has a median particle size D50 = 550,5 µm, which was determined by laser diffraction measurement.
Executive summary:

The test item has a median particle size D50 = 550,5 µm, which was determined by laser diffraction measurement.