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Diss Factsheets

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:
21. – 22. 10. 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances, EUR 20268 EN (2002)
Qualifier:
according to guideline
Guideline:
other: ISO 2591-1 Test sieving - Part 1: Methods using test sieves of woven wire cloth and perforated metal plate, First edition 1988-12-01
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
474-080-4
EC Name:
-
Cas Number:
76801-93-9
Molecular formula:
C14H18I3N3O6
IUPAC Name:
5-amino-N1,N3-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
impurity 1
Reference substance name:
Unknown impurities
Molecular formula:
Not available
IUPAC Name:
Unknown impurities
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 00104016
- Expiration date of the lot/batch: 12/2020

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in cool place. Keep container tightly closed in a dry and well-ventilated place.
- Stability under test conditions: Stable

Results and discussion

Particle size distribution at different passagesopen allclose all
No.:
#2
Size:
4 mm
Distribution:
2.87 %
No.:
#3
Size:
2 mm
Distribution:
37.86 %
No.:
#4
Size:
1.4 mm
Distribution:
21.73 %
No.:
#6
Size:
0.71 mm
Distribution:
8.37 %
No.:
#7
Size:
0.5 mm
Distribution:
7.02 %
No.:
#8
Size:
0.355 mm
Distribution:
5.62 %
No.:
#9
Size:
0.25 mm
Distribution:
2.05 %
No.:
#10
Size:
< 0.25 mm
Distribution:
3.57 %

Applicant's summary and conclusion