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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:
2008-04-16 till 2008-04-17
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: European Commission, Draft Guideance Document, EUR 20268 EN (2002), Part 5.2 "Laser scattering/diffraction"
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of distribution:
counted distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 40840/A TE
- Substance type: colouring dye
- Physical state: solid, dark red powder
- Analytical purity: approx. 78.9% org. part (NA-salt), MC: 37.7%, Oligomers: 19.2%
- Purity test date:
- Lot/batch No.: ROE 358 BOP 01/07
- Expiration date of the lot/batch: June 30, 2012
- Storage condition of test material: At room temperature at about 20°C

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
5.7 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
< 1.7 µm
St. dev.:
0.135
Percentile:
D50
Mean:
< 5.7 µm
St. dev.:
0.572
Percentile:
D90
Mean:
< 14 µm
St. dev.:
2.532
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 40 µm
Distribution:
100 %
No.:
#2
Size:
< 6 µm
Distribution:
52.83 %
No.:
#3
Size:
< 3 µm
Distribution:
23.53 %
No.:
#4
Size:
< 0.5 µm
Distribution:
1.5 %

Any other information on results incl. tables

FAT 40840/A TE is a fine purple powder. Under the microscope (with a magnification of 400) small, pink crystalline structures were observed. A solubility test showed, that the test item is both: sparingly soluble and well dispersible in ethanol. The particle size distribution of FAT 4084 /A TE was performed with three samples of the stock dispersion each measured in duplicate. The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.

[%]  1st Run Particle Size [μm]  2nd Run Particle Size [μm]  3rd Run Particle Size [μm]  4th Run Particle Size [μm]  5th Run Particle Size [μm] 6th Run Particle Size [μm]   Mean Particle Size [μm]   Stand. Dev.[±]  
 5 <1.07   <1.06   <1.16   <1.14   <0.95   <0.95   <1.1  0.089
 10  <1.67   <1.64   <1.81   <1.78   <1.50   <1.49   <1.7  0.135
 50  <5.76 <5.65    <6.45   <6.33   <5.12   <5.11   <5.7*  0.572
 90  <14.51  <14.33  <16.99  <16.20  <11.09  <10.93  <14.0  2.532
                 

* The MMD of the test item indicates that 50% (by mass) of the particles are smaller than 5.7 μm.

Applicant's summary and conclusion

Conclusions:
In conclusion, using the laser diffraction method to study the particle size of FAT 40840/A TE
ranging between 0.3 μm and 300 μm, the mass median diameter (MMD) was determined to be
5.7 μm.
The particle size distribution was found to range from approximately 0.3 μm to 300 μm.
Executive summary:

The laser scattering / diffraction was used to determine the particle size distribution of FAT 40840/A TE ranging between 0.3 μm and 300 μm, the mass median diameter (MMD) was determined to be 5.7 μm. The particle size distribution was found to range from approximately 0.3 μm to 300 μm.