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Physical & Chemical properties

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: BS ISO 13320-1:1999
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
other: Laser diffraction
Mass median aerodynamic diameter:
75.259 µm
Geometric standard deviation:
3.588
Percentile:
D10
Mean:
11.892 µm
Remarks on result:
other: 0.54 % STDV
Percentile:
D50
Mean:
60.064 µm
Remarks on result:
other: 1.20 % STDV
Percentile:
D90
Mean:
184.771 µm
Remarks on result:
other: 1.01 % STDV

The particle size was analysed over the range 0.02 to 2000μm.

Full test results:

 

Run 1

Run 2

Run 3

Run 4

Run 5

** Average

Volume weighted mean

81.273

82.203

79.653

81.327

80.563

81.004

Median (d50)

60.003

60.923

58.818

60.621

59.995

60.064

Mode (μm)

103.568

108.776

102.165

108.915

104.519

105.386

*MMAD

75.184

76.336

73.699

75.957

75.174

75.259

10 % of material is >

11.817

11.951

11.810

11.941

11.942

11.892

50 % of material is >

60.003

60.923

58.818

60.621

59.995

60.064

90 % of material is >

184.522

187.880

182.302

185.435

183.639

184.771

All results are in μm.

* Mean Mass Aerodynamic Diameter

** Average result is calculated from the entirety of the data captured in each run and is not a simple arithmetic mean.

7.78 % by volume of sample was seen to be < 10μm.

Standard deviation results:

Run No.

1

2

3

4

5

STDVP

% STDV

d10

11.817

11.951

11.810

11.941

11.942

0.06

0.54

d50

60.003

60.923

58.818

60.621

59.995

0.72

1.20

d90

184.522

187.880

182.302

185.435

183.639

1.87

1.01

d15.78

16.61

16.85

16.61

16.83

16.81

0.11

0.65

GSD

3.612

3.616

3.541

3.602

3.569

0.03

0.80

MMAD

75.184

76.336

73.699

75.957

75.174

0.90

1.20

GSD = Geometric standard deviation

Coefficient of variation for d50 is less than 3 %; d10 and d90 are less than 5 %. Thus repeatibility of the characteristic particles in the size distribution are within the acceptable limits as per the BS ISO 13320-1 test standard.

Conclusions:
7.78 % by volume of sample was seen to be < 10.00 μm.
D50 = 60.064 µm
Executive summary:

The test substance was assessed for particle size distribution in a GLP study (2010) according to OECD Guideline 110, CIPAC Method MT 187 and BS ISO 13320-1:1999. The d50 was 60.064 μm. 7.78 % by volume of sample was seen to be < 10.00 μm. Coefficient of variation for d50 is less than 3 %; d10 and d90 are less than 5 %. Thus repeatibility of the characteristic particles in the size distribution are within the acceptable limits as per the BS ISO 13320-1 test standard.

Description of key information

The test substance was assessed for particle size distribution in a GLP study (2010) according to OECD Guideline 110, CIPAC Method MT 187 and BS ISO 13320-1:1999. The d50 was 60.064 μm.  7.78 % by volume of sample was seen to be < 10.00 μm.  Coefficient of variation for d50 is less than 3 %; d10 and d90 are less than 5 %.  Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the BS ISO 13320-1 test standard.

Additional information