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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:
31 October 2017- 01 March 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ of 2002
GLP compliance:
yes (incl. QA statement)
Type of method:
cascade impaction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hydroxy-N-1H-1,2,4-triazol-3-ylbenzamide
EC Number:
253-021-4
EC Name:
2-hydroxy-N-1H-1,2,4-triazol-3-ylbenzamide
Cas Number:
36411-52-6
Molecular formula:
C9H8N4O2
IUPAC Name:
2-hydroxy-N-1H-1,2,4-triazol-3-ylbenzamide
Test material form:
solid: particulate/powder
Details on test material:
Batch:102Z5
Purity: 99.9%
white powder

Results and discussion

Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
ca. 96.3 %
No.:
#2
Size:
< 10 µm
Distribution:
ca. 1.07 %
No.:
#3
Size:
< 5.5 µm
Distribution:
ca. 0.101 %

Applicant's summary and conclusion

Conclusions:
Particle size data acquired for the test item:

Percentage of test item with an inhalable particle size <100 μm, (Method: Sieve), 96.3%
Percentage of test item with a thoracic particle size <10.0 μm, (Method: Cascade Impactor), 1.07%
Percentage of test item with a respirable particle size <5.5 μm, (Method: Cascade Impactor), 0.101%

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