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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
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:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Deviations:
no
GLP compliance:
yes
Type of method:
other: scanning electron microscopy after the sample was fractionated by a 100 μm sieve
Type of distribution:
mass based distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Mass median aerodynamic diameter:
14.44 µm
Remarks on result:
other: as spherical particles (Sieve Fraction nominal < 100μm)
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 4 µm
Distribution:
0 %
Remarks on result:
other: respirable fraction; accounting based on the total sample weight
No.:
#2
Size:
>= 4 - < 10 µm
Distribution:
0.04 %
Remarks on result:
other: thoracic fraction; accounting based on the total sample weight
No.:
#3
Size:
>= 10 - < 100 µm
Distribution:
2.16 %
Remarks on result:
other: inhalable fraction; accounting based on the total sample weight

Applicant's summary and conclusion

Conclusions:
Particle size distribution was determined according to OECD 110 (GLP), so there is no reason to conclude that the results are not reliable. The study was assessed to be of high quality and testing is expected to be reasonably performed; results can be considered as reliable. The substance contains 0 % respirable particles (< 4 µm), 0.04 % thoracic particles (4-10 µm) and 2.16 % inhalable particles (10-100 µm).
Executive summary:

The particle size distribution of the test substance was determined by scanning electron microscopy after the samples was fractionated by a 100 μm sieve according to OECD Guideline 110 (GLP).

Sieve Fraction

weighted sample: 0.8451 g

weight fraction < 100 μm: 0.0186 g

sieve mass fraction < 100 μm: 2.20 %

Mass Fraction

Sieve Fraction nominal < 100μm

Particle Size   Spherical Volume  Cubical volume
 < 4 µm (respirable)  0.00 %  0.00 %
 4 -10 µm (thoracic)  1.97 %  2.42 %
 10 -100 µm (inhalable)  98.03 %  97.58 %
 > 100 µm  0.0 %  0.0 %
 Median (diameter)  14.44 µm  13.45 µm

Median diameter corresponds to MMAD (Mass Median Aerodynamic Diameter < 100μm).

Accounting based on the total sample weight:

   Particle Size [µm]  Spherical Volume [%]
 Mass Fraction  > 100  97.80
 Sieve Fraction  > 100  0.00
 Total (> 100 µm)    97.80
 Sieve Fraction  10 -100 (inhalable)  2.16
 Sieve Fraction  4 -10 (thoracic)  0.04
 Sieve Fraction  < 4 (respirable)  0.00

Median diameter corresponds to MMAD (Mass Median Aerodynamic Diameter < 100μm).