Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
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
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
Type of method:
sieving
Remarks:
Scanning electron microscopy
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
Batch number: CN61204501
Date of receipt: 2017-03-02
Expiry date: 2018-07-24
Mass median aerodynamic diameter:
5.41 µm
Size:
< 4 µm
Distribution:
3.04 %
Remarks on result:
other: Spherical Volume
Size:
< 4 µm
Distribution:
3.23 %
Remarks on result:
other: Cubical Volume
Size:
>= 4 - <= 10 µm
Distribution:
41.72 %
Remarks on result:
other: Spherical Volume
Size:
>= 4 - <= 10 µm
Distribution:
42.72 %
Remarks on result:
other: Cubical Volume
Size:
>= 10 - <= 100 µm
Distribution:
55.24 %
Remarks on result:
other: Spherical Volume
Size:
>= 10 - <= 100 µm
Distribution:
54.05 %
Remarks on result:
other: Cubical Volume
Size:
> 100 µm
Distribution:
0 %
Remarks on result:
other: Spherical Volume
Size:
> 100 µm
Distribution:
0 %
Remarks on result:
other: Cubical Volume

Conclusion

       Accounting based on the total sample weight
   Particle Size [μm]  Spherical Volume [%]
 Mass Fraction  >100  26.93
 Sieve Fraction  >100  0.00
 Total (>100μm)    26.93
 Sieve Fraction  10 -100 (inhalable)  40.37
 Sieve Fraction  4-10 (thoracic)  30.49
 Sieve Fraction  <4 (respirable)  2.22

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value of 5.41 µm as spherical particles.

Conclusions:
The particle size distribution of Vulkacit P extra N was determined by scanning electron microscopy after the samples was fractionated by a 100 μm sieve. The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value of 5.41 µm as spherical particles.
Executive summary:

The particle size distribution of Vulkacit P extra N was determined by scanning electron microscopy after the samples was fractionated by a 100 μm sieve.

Sieve Fraction:

weighted sample: 0.8059 g

weight fraction <100 μm: 0.5889 g

mass fraction <100 μm: 73.07 %

Mass Fraction:

Sieve Fraction nominal < 100μm

 Particle Size  Spherical Volume  Cubical Volume
 <4 μm (respirable)  3.04 %  3.23 %
 4-10 μm (thoracic)  41.72 %  42.72 %
 10-100 μm (inhalable)  55.24 %  54.05 %
 >100 μm  0.00 %   0.00 %
 Median (diameter μm)  5.41 μm  5.22 μm

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value of 5.41 µm as spherical particles.

       Accounting based on the total sample weight

   Particle Size [μm]  Spherical Volume [%]
 Mass Fraction  >100  26.93
 Sieve Fraction  >100  0.00
 Total (>100μm)    26.93
 Sieve Fraction  10-100 (inhalable)  40.37
 Sieve Fraction  4-10 (thoracic)  30.49
 Sieve Fraction  <4 (respirable)  2.22

Description of key information

The particle size distribution of Vulkacit P extra N was determined by scanning electron microscopy after the samples was fractionated by a 100 μm sieve.

Sieve Fraction:

weighted sample: 0.8059 g

weight fraction <100 μm: 0.5889 g

mass fraction <100 μm: 73.07 %

Mass Fraction:

Sieve Fraction nominal < 100μm

 Particle Size  Spherical Volume  Cubical Volume
 <4 μm (respirable)  3.04 %  3.23 %
 4-10 μm (thoracic)  41.72 %  42.72 %
 10-100 μm (inhalable)  55.24 %  54.05 %
 >100 μm  0.00 %   0.00 %
 Median (diameter μm)  5.41 μm  5.22 μm

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value of 5.41 µm as spherical particles.

       Accounting based on the total sample weight

   Particle Size [μm]  Spherical Volume [%]
 Mass Fraction  >100  26.93
 Sieve Fraction  >100  0.00
 Total (>100μm)    26.93
 Sieve Fraction  10-100 (inhalable)  40.37
 Sieve Fraction  4-10 (thoracic)  30.49
 Sieve Fraction  <4 (respirable)  2.22

Additional information