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Physical & Chemical properties

Particle size distribution (Granulometry)

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Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-06-07 - 2004-07-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Version / remarks:
June 1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
cascade impaction
Remarks:
Screening test: sieve method; Definitive test: cascade impactor method
Type of distribution:
mass based distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
Flucytosine
EC Number:
217-968-7
EC Name:
Flucytosine
Cas Number:
2022-85-7
Molecular formula:
C4H4FN3O
IUPAC Name:
flucytosine
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
please refer to Test material information

Results and discussion

Remarks on result:
other: Too few particles were of a size less than 10 µm to allow accurate assessment of mass median aerodynamic diameter.
Particle size
Key result
Remarks on result:
other: Too few particles were of a size less than 10 µm to allow accurate assessment of mass median aerodynamic diameter.
Particle size distribution at different passagesopen allclose all
No.:
#2
Size:
10.2 µm
Distribution:
10.9 %
Remarks on result:
other: Number given for No. specifies Cup Number
No.:
#3
Size:
5.4 µm
Distribution:
1.69 %
Remarks on result:
other: Number given for No. specifies Cup Number
No.:
#4
Size:
2.5 µm
Distribution:
0.928 %
Remarks on result:
other: Number given for No. specifies Cup Number
No.:
#5
Size:
1.67 µm
Distribution:
0.787 %
Remarks on result:
other: Number given for No. specifies Cup Number
Size:
0.393 µm
Distribution:
0.614 %
Remarks on result:
other: results for Filter

Any other information on results incl. tables

Screening test (sieve method)

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

 Sieve Aperture Size (µm)

  100

 Mass of test material transferred to sieve (g)

 10.5

 Mass of test material passed through sieve (g)

 4.0

 Test material less than sieve aperture size (%)

 38.1

Definitive test (cascade impactor method)

The results of the cascade impactor method are shown in the attached study report (pg 35 -37).

The cumulative amounts found for the individual particle size cut-points (µm) are shown in the

following table:

 Cup Number

 Particle Size Cut-points (µm)

 Cumulative Mass of Test Material (g)

 Cumulative Amount of

Test Material (%)

 2

10.2

 0.3098

10.9 

 3

5.4 

 0.0479

 1.69

 4

 2.5

 0.0263

 0.928

 5

 1.67

 0.0223

 0.787

 Filter

 0.393

 0.0174

 0.614

The overall cumulative amounts of test material with a particle size less than 10 µm (%) from Determinations 1 to 3 are shown in the following table:

 Determination

 Cumulative Amount of Test Material Less Than 10 µm (%)

 Mean Cumulative Amount of Test Material Less Than 10 µm (%)

 1

 11.8

 see below

 2

 15.3

 12.7

 3

 10.9

 see above

Discussion

Too few particles were of a size less than 10 µm to allow accurate assessment of mass median aerodynamic diameter.

Representative sampling was ensured by rolling the sample container for approximately 10 minutes and sampling from the top, middle and bottom prior to definitive testing.

Applicant's summary and conclusion

Conclusions:
Particle size data acquired for the test material showed:
The proportion of test material having a particle size less than 100 µm , as determined by the sieve method, is 38.1%.
The proportion of test material having a particle size less than 10 µm, as determined by the Cascade Impactor method, is 12.7%.
The results indicate that the proportion by mass of particles which, if inhaled, can be expected to achieve pulmonary deposition in man is 12.7%.