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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:
Experimental starting date: 09 April 2018, Experimental completion date: 12 April 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:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Deviations:
no
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:
N-octylpyridin-4-amine
EC Number:
265-019-0
EC Name:
N-octylpyridin-4-amine
Cas Number:
64690-19-3
Molecular formula:
C13H22N2
IUPAC Name:
N-octylpyridin-4-amine

Results and discussion

Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
12.2 %
No.:
#2
Size:
< 10 µm
Distribution:
0.182 %
No.:
#3
Size:
< 5.5 µm
Distribution:
0.011 %

Any other information on results incl. tables

Sieve Screening Test

The results of the sieving procedure are shown in the following table:

Table 2

Measurement

Result

Mass of test item transferred to sieve (W1)

16.05 g

Mass of test item passed through sieve (W3– W2)

1.96 g

Percentage of test item less than 100 µm

12.2%

Cascade Impactor

The results of the cascade impactor procedure are shown in the following table:

Table 3

Collection Stage

Particle Size Range Collected (µm)

Collected Mass (g)

Determination 1

Determination 2

Determination 3

Artificial throat

n/a

0.09

0.19

0.04

Sample Cup 1

>10.0

2.9314

2.7018

2.9365

Sample Cup 2

5.5 to 10.0

0.0038

0.0082

0.0031

Sample Cup 3

2.4 to 5.5

0.0000

0.0000

0.0002

Sample Cup 4

1.61 to 2.4

0.0001

0.0001

0.0000

Sample Cup 5

0.307 to 1.61

0.0000

0.0002

0.0000

Final Filter

<0.307

0.0002

0.0001

0.0001

Total mass of collected test item

3.0255

2.9004

2.9799

Mass of test item added

3.0491

2.9916

3.0374

The cumulative amounts of test item collected in the three determinations for the individual particle size cut-points are shown in the following table:

Table 4

Particle Size Cut Points (µm)

Cumulative Mass (g)

Cumulative Percentage (%)

Determination 1

Determination 2

Determination 3

Determination 1

Determination 2

Determination 3

<10.0

0.0041

0.0086

0.034

0.136

0.297

0.114

<5.5

0.0003

0.0004

0.0003

0.010

0.014

0.010

<2.4

0.0003

0.0004

0.0001

0.010

0.014

0.003

<1.61

0.0002

0.0003

0.0001

0.007

0.010

0.003

<0.307

0.0002

0.0001

0.0001

0.007

0.003

0.003

Mean cumulative percentage with a particle size less than 10.0 µm           :         0.182%
Mean cumulative percentage with a particle size less than 5.5 µm :         0.011%

Discussion

Sampling for the cascade impactor determinations was performed bytaking the samples from different areas of the test item.

Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Conclusion

Particle size data acquired for the test item is shown in the following table:

Table 5

Measurement

Method

Result

Percentage of test item with an inhalable particle size <100 µm

Sieve

12.2%

Percentage of test item with a thoracic particle size <10.0 µm

Cascade Impactor

0.182%

Percentage of test item with a respirable particle size <5.5 µm

Cascade Impactor

0.011%

 

Applicant's summary and conclusion

Conclusions:
Percentage of test item with an inhalable particle size <100 µm = 12.2%
Percentage of test item with a thoracic particle size <10.0 µm = 0.182%
Percentage of test item with a respirable particle size <5.5 µm = 0.011%