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:
17 February 2009 - 14 April 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study has been performed according to OECD and EC guidelines and according to GLP principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: BS ISO 13320-1:1999
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of distribution:
other: laser diffraction particle size analysis

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Custom Red #2
- Substance type: Violet powder
- Physical state: Solid
- Lot/batch No.: C50APR0805D
- Expiration date of the lot/batch: 08 January 2010
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
12.307 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
< 4.134 µm
St. dev.:
0.107
Percentile:
D50
Mean:
< 12.307 µm
St. dev.:
0.267
Percentile:
D90
Mean:
< 27.943 µm
St. dev.:
1.519

Applicant's summary and conclusion

Conclusions:
Using the Dry Powder Module, the laser diffraction test conducted to determine the particle size analysis produced the following results (in average µm):

Volume weighted mean: 16.649
Median (d.50): 12.307
Mode: 13.686
MMAD (Mass Median Aerodynamic Diameter): 13.082
10% of material is < 4.134
50% of material is < 12.307
90% of material is < 27.943