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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:
March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice (GLP) within the national GLP monitoring programme, but the study report has not been audited by the Quality Assurance Unit. A formal claim of GLP compliance cannot therefore be made.
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Remarks:
The data contained in this report has been generated in a laboratory holding a current statement of GLP Compliance, issued by the UK GLP Monitoring Authority, MHRA, but not as part of a formal GLP study.
Type of method:
Laser scattering/diffraction
Type of distribution:
counted distribution
Mass median aerodynamic diameter:
> 4.573 - < 9.151 µm
Percentile:
D50
Mean:
> 6.216 - < 11.967 µm
Remarks on result:
other: See report(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Key result
Percentile:
D10
Mean:
>= 0.994 - <= 2.145 µm
St. dev.:
0.423
Key result
Percentile:
D50
Mean:
>= 6.216 - <= 11.967 µm
St. dev.:
2.074
Key result
Percentile:
D90
Mean:
>= 19.767 - <= 325.56 µm
St. dev.:
113.319
No.:
#1
Size:
>= 0 - < 2 000 µm
Distribution:
ca. 98.11 %
Remarks on result:
other: This result derived from sieve method and 98.11 % fall within this range
No.:
#2
Size:
> 2 000 µm
Distribution:
ca. 1.89 %
Remarks on result:
other: This result derived from sieve method and 1.89 % fall within this range

A manual sieve analysis indicated that 1.89% w/w of the test substance had a particle size of >2000 µm and 98.11 % w/w of the test substance had a particle size of < 2000µm.

 

A subsequent laser diffraction analysis on the <2000µm sample produced the following results:

 

 

Average (µm)

Volume weighted mean

67.739

Median (d.50)

8.329

Mode

54.642

MMAD (Mass Median Aerodynamic Diameter)*

6.369

10 % of the material is <

1.441

50 % of the material is <

8.329

90 % of the material is <

205.496

*Mass Median Aerodynamic Diameter (Density 1.71, and shape factor approximately 1)

Conclusions:
A manual sieve analysis indicated that 1.89% w/w of the test substance had a particle size of > 2000 µm and 98.11 % w/w of the test substance had a particle size of < 2000 µm.
By direct observation the test substance was observed to be fine white powder, with larger agglomerates present.

With the 20x objective the particles appeared to be homogeneously consisted of primary particles of 2~5 μm. Agglomerates of ~50 μm were also present.
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice (GLP) within the national GLP monitoring programme, but the study report has not been audited by the Quality Assurance Unit. A formal claim of GLP compliance cannot therefore be made.
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Remarks:
The data contained in this report has been generated in a laboratory holding a current statement of GLP Compliance, issued by the UK GLP Monitoring Authority, MHRA, but not as part of a formal GLP study.
Type of method:
Laser scattering/diffraction
Type of distribution:
counted distribution
Mass median aerodynamic diameter:
> 3.758 - < 5.021 µm
Geometric standard deviation:
> 3 - < 5
Percentile:
D50
Mean:
> 4.943 - < 6.604 µm
Remarks on result:
other: See report(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Key result
Percentile:
D10
Mean:
>= 0.745 - <= 0.913 µm
St. dev.:
0.059
Key result
Percentile:
D50
Mean:
>= 4.943 - <= 6.604 µm
St. dev.:
0.608
Key result
Percentile:
D90
Mean:
>= 107.266 - <= 141.579 µm
St. dev.:
12.627
No.:
#1
Size:
>= 0 - < 2 000 µm
Distribution:
ca. 96.24 %
Remarks on result:
other: This result derived from sieve method and 96.24 % fall within this range
No.:
#2
Size:
> 2 000 µm
Distribution:
ca. 3.76 %
Remarks on result:
other: This result derived from sieve method and 3.76 % fall within this range

A manual sieve analysis indicated that 3.76% w/w of the test substance had a particle size of >2000 µm and 96.24 % w/w of the test substance had a particle size of < 2000 µm.

 

A subsequent laser diffraction analysis on the <2000 µm sample produced the following results:

 

 

Average (µm)

Volume weighted mean

36.588

Median (d.50)

5.518

Mode

3.979

MMAD (Mass Median Aerodynamic Diameter)*

4.196

10 % of the material is <

0.803

50 % of the material is <

5.518

90 % of the material is <

122.079

*Mass Median Aerodynamic Diameter (Density 1.73, and shape factor approximately 1)

Conclusions:
A manual sieve analysis indicated that 3.76% w/w of the test substance had a particle size of > 2000 µm and 96.24 % w/w of the test substance had a particle size of < 2000 µm.
By direct observation the test substance was observed to be fine white powder, with larger agglomerates present.

With the 20x objective the particles appeared to be homogeneously consisted of primary particles of 0.5~1 μm. Agglomerates of 15~50 μm were also present.
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice (GLP) within the national GLP monitoring programme, but the study report has not been audited by the Quality Assurance Unit. A formal claim of GLP compliance cannot therefore be made.
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Remarks:
The data contained in this report has been generated in a laboratory holding a current statement of GLP Compliance, issued by the UK GLP Monitoring Authority, MHRA, but not as part of a formal GLP study.
Type of method:
Laser scattering/diffraction
Type of distribution:
counted distribution
Mass median aerodynamic diameter:
> 5.013 - < 5.07 µm
Geometric standard deviation:
> 3 - < 5
Percentile:
D50
Mean:
> 6.556 - < 6.747 µm
Remarks on result:
other: See report(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Key result
Percentile:
D10
Mean:
>= 1.089 - <= 1.134 µm
St. dev.:
0.015
Key result
Percentile:
D50
Mean:
>= 6.63 - <= 6.747 µm
St. dev.:
0.062
Key result
Percentile:
D90
Mean:
>= 89.693 - <= 110.526 µm
St. dev.:
7.77
No.:
#1
Size:
>= 0 - < 2 000 µm
Distribution:
ca. 90.26 %
Remarks on result:
other: This result derived from sieve method and 90.26 % fall within this range
No.:
#2
Size:
> 2 000 µm
Distribution:
ca. 9.74 %
Remarks on result:
other: This result derived from sieve method and 9.74 % fall within this range

A manual sieve analysis indicated that 9.74% w/w of the test substance had a particle size of >2000 µm and 90.26 % w/w of the substance had a particle size of < 2000 µm.

 

A subsequent laser diffraction analysis on the <2000µm sample produced the following results:

 

 

Average (µm)

Volume weighted mean

24.475

Median (d.50)

6.648

Mode

7.051

MMAD (Mass Median Aerodynamic Diameter)*

5.084

10 % of the material is <

1.109

50 % of the material is <

6.648

90 % of the material is <

98.949

*Mass Median Aerodynamic Diameter (Density 1.71, and shape factor approximately 1)

Conclusions:
A manual sieve analysis indicated that 9.74% w/w of the test substance had a particle size of > 2000 µm and 90.26 % w/w of the substance had a particle size of < 2000 µm.
By direct observation the test substance was observed to be fine white powder, with larger agglomerates present.

With the 20x objective the particles appeared to be homogeneously consisted of primary particles or 1~10 μm. Larger particles of 20~50 μm were also observed, some of which appeared to be agglomerates.

Description of key information

A manual sieve analysis indicated that ca. 94.87% w/w of the test substance had a particle size of < 2000µm.

With the 20x objective the particles appeared to be homogeneously consisted of primary particles or 5 μm.

Additional information