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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:
21 October 2013 to 13 December 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: non GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: European Commission Technical Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' (2002)
GLP compliance:
yes
Remarks:
OECD Principles on Good Laboratory Practice (revised 1997, ENV/MC/CHEM(98)17)
Type of distribution:
mass based distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all

Any other information on results incl. tables

Using the data obtained from the cascade impactor method determinations, the cumulative mass and cumulative percentage are calculated as follows:

 

Collection Stage

Particle Size Range Collected (µm)

Mass at

Stage (g)

Cumulative

Mass (g)

Cumulative

Percentage (%)

Artificial Throat

-

mo

Mo

100

Sample Cup 1

>10.0

 

m1

 

M1

 

100 x M1/Mo

Sample Cup 2

5.5 to 10.0

m2

 

M2

100 x M2/Mo

Sample Cup 3

2.4 to 5.5

m3

M3

l00 x M3/Mo

Sample Cup 4

1.61 to 2.4

 

m4

 

M4

 

100 x M4/Mo

Sample Cup 5

0.307 to 1.61

ms

Ms

100 x M5/Mo

Final Filter

<0.307

 

m6

 

M6

100 x M6/Mo

Where:

m = mass of test item (g) found at collection stage.

M  = cumulative mass (g) from collection stage on (eg M3=m3 + m4 +m5 +m6)

Applicant's summary and conclusion

Conclusions:
98.5% of particles were <100um.
5.67% of particles were <10.0um.
2.51% of particles were <5.5um
Executive summary:

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

Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 15 minutes then sampled from the top, middle and bottom.