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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 13, 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study has been performed similar to BS ISO 13320-1: 1999, OECD 110 and according to GLP principles. Limited information available to verify the composition of the used test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
other: BS ISO 13320-1: 1999
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
not specified
Principles of method if other than guideline:
Although these guidelines are not mentioned in the report, it is mentioned that the test equipment and method are recognised by OECD guidelines.
GLP compliance:
yes (incl. certificate)
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): KY-ET
- Appearance: white powder
- Storage condition of test material: at room temperature in the dark

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Remarks on result:
other: MMAD: not determined(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Percentile:
D50
Mean:
15.37 µm
St. dev.:
3.69
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
1.437 µm
Distribution:
< 10 %
Remarks on result:
other: Average of 3 runs
No.:
#2
Size:
4.945 µm
Distribution:
< 25 %
Remarks on result:
other: Average of 3 runs
No.:
#3
Size:
15.37 µm
Distribution:
< 50 %
Remarks on result:
other: Average of 3 runs
No.:
#4
Size:
33.95 µm
Distribution:
< 75 %
Remarks on result:
other: Average of 3 runs
No.:
#5
Size:
51.71 µm
Distribution:
< 90 %
Remarks on result:
other: Average of 3 runs

Any other information on results incl. tables

Optical Microscope Analysis

- Standard visual observation: Sample observed to be a free-flowing, fine, white powder which forms clusters

- Observation at 100 x magnification: The particles appeared to be amorphous crystals of irregular shape.The smallest particle size was approx. 7.5 μm and the largest size was approx. 103 μm. The particle size distribution was approx. 80% < 80 μm and 20% 80 μm.

- Observation at 400 x magnification: The sample was observed to be made up of single crystalline particles.

Manual sieve analysis

Not used. The sample was analysed as received.

Laser diffraction particle size analysis

- Run 1 failed to meet the Coulter obscuration requirements and is therefore excluded from the results;

 

RUN 2

RUN 3

RUN 4

Average

Volume %

100.0

100.0

100.0

100.0

Mean (µm)

12.42

12.47

10.08

11.60

Median (µm)

17.16

16.39

13.00

15.37

Mode (µm)

51.12

55.99

42.61

51.12

95% Conf. Limit (µm)

0.943 -164

0.936 -166

0.842 -121

0.899 -150

S.D.

3.73

3.75

3.55

3.69

Applicant's summary and conclusion

Conclusions:
According to GLP principles the particle size distribution of the substance was determined using laser diffraction analysis. The median (D50) of the analysed sample was 15.37 µm.