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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:
2017/04/19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Version / remarks:
-
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyrrolidine, 1-[2-[2-nitro-4-(phenylmethoxy)phenyl]ethenyl]-
Cas Number:
99474-22-3
Molecular formula:
C19H20N2O3
IUPAC Name:
Pyrrolidine, 1-[2-[2-nitro-4-(phenylmethoxy)phenyl]ethenyl]-
Specific details on test material used for the study:
- Analytical purity: > 98.4%
 - Lot/batch No.: 0159115
 - Expiration date of the lot/batch: 21/02/2018

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D50
Mean:
ca. 40.4 µm
St. dev.:
2.5
Percentile:
D10
Mean:
ca. 7.3 µm
St. dev.:
0.2
Percentile:
D90
Mean:
ca. 222.8 µm
St. dev.:
23.3

Any other information on results incl. tables

Particle Size Distribution

Two test series of 3 measurements each were performed with the test item.

Test series 1:

D10:       7.4 µm

D50:       42.1 µm       (Median diameter)

D90:       239.3 µm

Test series 2:

D10:       7.1 µm

D50:       38.6 µm       (Median diameter)

D90:       206.3 µm

Average

D10:       7.3 µm

D50:       40.4 µm       (Median diameter)

D90:       222.8 µm

Applicant's summary and conclusion

Conclusions:
The test item IMEXINE OBA/50 SEC has a median particle size of D50 = 40 µm, which was determined by laser diffraction measurement.
Executive summary:

The test item IMEXINE OBA/50 SEC has a median particle size of D50 = 40 µm, which was determined by laser diffraction measurement, according to ISO 13320 in GLP-compliant conditions.