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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:
11 August 2008 to 30 January 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of distribution:
counted distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
426-290-2
EC Name:
-
Cas Number:
74149-72-7
Molecular formula:
C20H20N2O7
IUPAC Name:
methyl 4-[4-(4-methoxybenzamido)-3-nitrophenyl]-3-methyl-4-oxobutanoate
Details on test material:
- Name of test material (as cited in study report): GAMMA NAP
- Substance type: monoconstituent
- Physical state: yellow powder
- Analytical purity: 99.9%
- Purity test date: 11 January 2008
- Lot/batch No.: 07/004/2
- Expiration date of the lot/batch: January 2009
- Storage condition of test material: in darkness at room temperature

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
143.872 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D90
Mean:
409.384 µm
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
<= 1 mm
Distribution:
0.07 %
No.:
#2
Size:
<= 100 µm
Distribution:
27.2 %
No.:
#3
Size:
<= 90 µm
Distribution:
18.7 %
No.:
#4
Size:
<= 63 µm
Distribution:
0.2 %

Applicant's summary and conclusion

Executive summary:

Preliminary sieving:

The majority of the particles was lower than 100 µm. So the principal sieving was made lower than 100 µm.

Principal sieving:

As the powder was fine and sticky, the particle size distribution was made by laser granulometry.

Particle size distribution by laser diffraction:

Median diameter: 143.872 µm

Mean diameter: 233.977 µm

D(0.9): 409.384 µm