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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
DIN 55992-1 (Determination of a parameter for the dust formation of pigments and extenders - Part 1: Rotation method)
Version / remarks:
2008
Deviations:
yes
Remarks:
instead of the Heubach dust meter was used a seven stage cascade impactor
Principles of method if other than guideline:
instead of the Heubach dust meter was used a seven stage cascade impactor to determined the dust fractions accordning to DIN EN 481.
Air flow rate 40 L/min instead of 20L/ min (reason: use of cascade impactor instead of Heubach dust meter)
GLP compliance:
no
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Mass median aerodynamic diameter:
> 2.6 µm
Geometric standard deviation:
> 1 - < 100
Remarks on result:
other: no data
Percentile:
D50
Mean:
ca. 20 µm
Remarks on result:
other: according DIN EN 481
No.:
#1
Size:
> 100 µm
Distribution:
0 %
No.:
#2
Size:
> 63 - < 100 µm
Distribution:
14.99 %
No.:
#3
Size:
> 25.48 - < 63 µm
Distribution:
23 %
No.:
#4
Size:
> 12.41 - < 25.46 µm
Distribution:
55.76 %
No.:
#5
Size:
> 6.39 - < 12.41 µm
Distribution:
5.6 %
No.:
#6
Size:
> 3.19 - < 6.39 µm
Distribution:
0.43 %
No.:
#7
Size:
> 1.6 - < 3.19 µm
Distribution:
0.03 %

Quantity of substance used: 1g

Total dust mass in impactor: 138.31 mg

Dust concentration in impactor: 698.40 mg/m³

Total dustiness: 180.31 mg/g

Inhalable fraction: 80.59 mg/g

Thoracic fraction: 6.76 mg/g

Respirable fraction: 0.17 mg/g

values according to EN 481

Determination of the concentration of respirable fraction in impactor:

(Dust concentration in the impactor) / (total dust mass in the impactor) x (respirable fraction) = 0.85 mg/m³

Conclusions:
The concentration of the respirable fraction in the impactor is 0.85 mg/m³. The exposure limit for workplace is for the respirable fraction 1 mg/m³. The short time exposure limit is higher. So there is no danger from this substance.
Executive summary:

A sieve test was done in a non-GLP study similar to DIN 55992-1 according to ISO/IEC 17025. The particle size disribution shows, that there are no particles bigger than 100 µm. 14.99 % of the particles are in the range between 63 and 100 µm, 23 % in the range between 25.48 and 63 µm, 55.76 % in the range between 12.41 and 25.48 µm, 5.6 % in the range between 6.39 and 12.41 µm, 0.34 % in the range between 3.19 and 6.39 µm and 0.03 % in the range between 1.6 and 3.19 µm. The d50 is estimated to be about 20 µm.

Description of key information

A sieve test was done in a non-GLP study similar to DIN 55992-1 according to ISO/IEC 17025. The particle size disribution shows, that there are no particles bigger than 100 µm. 14.99 % of the particles are in the range between 63 and 100 µm, 23 % in the range between 25.48 and 63 µm, 55.76 % in the range between 12.41 and 25.48 µm, 5.6 % in the range between 6.39 and 12.41 µm, 0.34 % in the range between 3.19 and 6.39 µm and 0.03 % in the range between 1.6 and 3.19 µm. The d50 is estimated to be about 20 µm.

Additional information

The concentration of the respirable fraction in the impactor is 0.85 mg/m³. The exposure limit for workplace is for the respirable fraction 1 mg/m³

the short time exposure limit is higher. So the is no danger through this substance.

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