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:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The particle size of the commercial product was measured by the manufacturer's Quality Control Unit. The average size of different lots manufactured between April 1995 April 1996 was reported.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A Horiba laser light scattering instrument (Horiba LA900 Model 7991) was used. The sample was was weighed (typically ~0.01 to 0.15 g) into a clean dry aluminium cup. The instrument autosampler dispersed the sample in water using a dispersant and ultransonic treatment. The suspension was circulated through a measuring cell where the powder particles scattered a beam of laser light. Detectors in the intrument measured the intensity of the light scattered. The instrument's computer calculates the average particle size. Typically, 10 separate representative samples are tested. The instrument counts the number of particles in in the range of 0.04 to 2000 micro-m.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
counted distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Results and discussion

Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
> 1 µm
Distribution:
100 %
No.:
#2
Size:
> 10 µm
Distribution:
0 %
No.:
#3
Size:
2.687 µm
Distribution:
50 %
Remarks on result:
other:
Remarks:
D50, St. dev. was 1.257 µm

Applicant's summary and conclusion

Conclusions:
The mean particle size of different lots of the commercial product measured between April 1995 - April 1996 was 2.687 microns.
Executive summary:

The mean particle size of different lots of the commercial product measured June 2011 was 2.687microns.