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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: according to international standard

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EN 933-1 sieve analysis
Principles of method if other than guideline:
Over the period year 2006 to year 2008 a total of 39 samples of the test susbtance were examined according to the EN 933-1 method (Sieve analysis), the smallest standard commercial grade of the substance was used ( 40 mm) as part of production quality control. The ammassed results are presented here.
GLP compliance:
no
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Stability under test conditions: stable

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Remarks on result:
other: not reported(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Remarks on result:
other: refer to particle size distribution at different passages
Particle size distribution at different passagesopen allclose all
Size:
< 6 µm
Distribution:
1 %
Remarks on result:
other: over the period 2006-2008 the average of particles < 0,063 mm was 1,3% (m/m). Standard deviation 1,2
Size:
< 12 µm
Distribution:
3 %
Remarks on result:
other: over the period 2006-2008 the average of particles <0,125 mm was 3,0% (m/m) Standard deviation 1,4
Size:
< 25 µm
Distribution:
5 %
Remarks on result:
other: Over the period 2006-2008 the average of particles <0,250 mm was 5,1% Standard deviation 1,8

Applicant's summary and conclusion

Conclusions:
The average percentage of particles with a diametre of < 0,063 mm in the test substance ( smallest commercial standard 0/40) is 1,3 (m/m) % with a standard deviation of 1,2 according to method EN 933-1
Executive summary:

The average percentage of particles with a diametre of < 0,063 mm in the test substance is 1,3 (m/m) % with a standard deviation of 1,2 according to method EN 933-1