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Physical & Chemical properties

Particle size distribution (Granulometry)

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Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 Feb 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Qualifier:
according to guideline
Guideline:
other: ISO 13317-2, Determination of particle size distribution by gravitational liquid sedimentation methods - Part 2: Fixed pipette method.
GLP compliance:
yes (incl. QA statement)
Remarks:
Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany
Type of method:
sedimentation (gravitational settling)
Type of distribution:
other: gravitational liquid sedimentation
No.:
#1
Size:
< 3.26 µm
Distribution:
3.22 %
No.:
#2
Size:
< 6.24 µm
Distribution:
9.66 %
No.:
#3
Size:
< 9.02 µm
Distribution:
12.9 %
No.:
#4
Size:
< 13.16 µm
Distribution:
16.39 %
No.:
#5
Size:
< 18.38 µm
Distribution:
23.9 %
No.:
#6
Size:
< 26.5 µm
Distribution:
39.72 %
No.:
#7
Size:
< 38.17 µm
Distribution:
59.81 %
No.:
#8
Size:
< 49.14 µm
Distribution:
77.23 %
No.:
#9
Size:
< 64.53 µm
Distribution:
81.81 %
No.:
#10
Size:
< 113.62 µm
Distribution:
94.12 %

In both experiments, sedimentation took place already before the first sampling time: in the two experiments, 7.3% resp. 8.8% of the particles were not retrieved when determining the 100% value. These particles must be considered as larger than the upper Stokes diameter. The distribution in the table about the "particle size distribution at different passages" applies only to the measurable part.

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:
other: GLP-Guideline study
Qualifier:
according to guideline
Guideline:
other: European Commission, Directorate general XII- JRC, Science Research and Development-Joint Research centre. "Particle size distribution, fibre length and diameter distribution". Guidance document, ECB/TM/February 1996.
Qualifier:
according to guideline
Guideline:
other: European Commission, Directorate general JRC, Joint Research Centre. "Particle size distribution, fibre length and diameter distribution". Draft guidance document, EUR 20268 EN (2002), Part 5.2 "Laser scattering / diffract".
GLP compliance:
yes (incl. QA statement)
Remarks:
Swiss federal office of public health, Bern, Switzerland
Type of method:
Laser scattering/diffraction
Type of distribution:
counted distribution
Percentile:
D10
Mean:
< 6.6 µm
St. dev.:
0.153
Percentile:
D50
Mean:
< 29.6 µm
St. dev.:
0.636
Percentile:
D90
Mean:
< 52 µm
St. dev.:
2.25

Lanthanum carbonate is a fine, white, compact powder. Under the microscope (with a magnification of 400) colourless, cubic crystalline structures were observed.

A solubility test showed, that the test item is both: sparingly soluble and well dispersible in water.

The particle size distribution was found to range from approximately 0.3 µm to 100 µm.

Particle size distribution:

 

1stRun

Particle Size

2ndRun

Particle Size

3rdRun

Particle Size

4thRun

Particle Size

Mean

Particle Size

Stand.

Dev.

[%]

[µm]

[µm]

[µm]

[µm]

[µm]

[±]

5

3.48

3.69

3.45

3.76

3.6

0.153

10

6.28

6.76

6.25

7.08

6.6

0.400

50

29.36

28.76

29.99

30.15

29.6 *

0.636

90

51.80

49.15

54.62

52.40

52.0

2.250

*) The MMD of the test item indicates that 50 % (by mass) of the particles are smaller than 29.6 µm.

The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (in analytical certification of test substance)
GLP compliance:
not specified
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Percentile:
D10
Mean:
30.7 µm
Percentile:
D50
Mean:
78.8 µm
Percentile:
D90
Mean:
164.5 µm

The standard deviation was not specified.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
8 Sep 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (comparable to guideline/standards)
Principles of method if other than guideline:
The particle size distribution was analyzed using an ANDERSEN cascade impactor (the individual impactor stages (glass plates) were subjected to gravimetric analysis). The determination was part of an acute inhalation study, in which the test substance was aerosolized using a Wright-Dust-Feeder.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
D50
Mean:
6.93 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
No.:
#1
Size:
0.01 - 0.4 µm
Distribution:
0 %
No.:
#2
Size:
0.4 - 0.7 µm
Distribution:
0 %
No.:
#3
Size:
0.7 - 1.1 µm
Distribution:
0.83 %
No.:
#4
Size:
1.1 - 2.1 µm
Distribution:
3.04 %
No.:
#5
Size:
2.1 - 3.3 µm
Distribution:
8.56 %
No.:
#6
Size:
3.3 - 4.7 µm
Distribution:
19.61 %
No.:
#7
Size:
4.7 - 5.8 µm
Distribution:
9.94 %
No.:
#8
Size:
5.8 - 9 µm
Distribution:
23.2 %
No.:
#9
Size:
9 - 30 µm
Distribution:
34.81 %

Sample 1:

Mass median aerodynamic diameter (MMAD): 6.93 µm

Geometric standard deviation (GSD): 2.07

Number median aerodynamic diameter (NMAD): 1.43 µm

Surface median aerodynamic diameter: 4.09 µm

Particle size distribution at different passages: see table above

Respirability:

Respirability

Mass related

Number related

percent < 1.0 µm

0.5 % (measured)

31.3 % (extrapolated)

percent < 3 µm

12.7 % (measured)

84.7 % (extrapolated)

percent < 5.0 µm

32.9 % (measured)

95.9 % (extrapolated)

Sample 2:

Mass median aerodynamic diameter (MMAD): 7.44 µm

Geometric standard deviation (GSD): 2.15

Number median aerodynamic diameter (NMAD): 1.28 µm

Surface median aerodynamic diameter: 4.14 µm

Particle size distribution at different passages:

No.

Size (µm)

Distribution (%)

#1

0.1-0.4

0

#2

0.4-0.7

0

#3

0.7-1.1

0

#4

1.1-2.1

0.86

#5

2.1-3.3

4.90

#6

3.3-4.7

11.53

#7

4.7-5.8

26.51

#8

5.8-9.0

34.29

#9

9.0-30.0

65.99

Respirability :

Respirability

Mass related

Number related

< 1.0 µm

0.5 % (measured)

37.3 % (extrapolated)

< 3 µm

12.1 % (measured)

86.7 % (extrapolated)

< 5.0 µm

30.3 % (measured)

96.3 % (extrapolated)

Description of key information

12.9%: < 9.02 µm, 16.39%: < 13.16 µm, 81.81%: < 64.53 µm (Paulus 2010)
D10 < 6.6 µm, D50 < 29.6 µm, D90 < 52 µm (Weissenfeld 2006)

Additional information

Two studies are available which examined the particle size distribution of Lanthanum carbonate.

In the first study, the particle size distribution was determined with gravitational liquid sedimentation according to ISO 13317-2 (Paulus 2010). Sedimentation took place already before the first sampling time: in the two experiments, 7.3% resp. 8.8% of the particles were not retrieved when determining the 100% value. These particles must be considered as larger than the upper Stokes diameter. The measurable part of the particle size distribution shows no single peaks, but a continous distribution with a main part between 13 and 60 µm, leaving fractions of approx. 20% (calculated from theoretical weight) above 114 µm and less than 15% blow 10 µm. Values for D10, D50 and D90 were not given.

The second study investigated the particle size distribution according to European Commission, Directorate general XII- JRC, Science Research and Development-Joint Research centre. "Particle size distribution, fibre length and diameter distribution". Guidance document, ECB/TM/February 1996 (Weissenfeld 2006). The particle size distribution was assessed using laser diffraction, yielding a D10 value of < 6.6 µm, D50 < 29.6 µm and D90 < 52 µm.