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:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
GLP compliance:
yes
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
counted distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Mass median aerodynamic diameter:
>= 49.3 - <= 209.1 µm
Remarks on result:
not determinable because of methodological limitations
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 2 µm
Distribution:
ca. 1.04 %
No.:
#1
Size:
>= 2 - <= 200 µm
Distribution:
ca. 72.59 %
No.:
#1
Size:
>= 200 µm
Distribution:
ca. 26.37 %

Any other information on results incl. tables

Using abinocular magnifier, the substance was visually confirmedas being a powder, not a fibre.

Three measurements were performed under acetone medium.

Applicant's summary and conclusion

Conclusions:
The particle size distribution of the test item SODIUM CHONDROITIN SULFATE has been determined and the following results were obtained:
-1.04 % of particles own a diameter under 2 µm.
-72.59 % of particles own a diameter between 2 µm and 200 µm.
-26.37 % of particles own a diameter over 200 µm.