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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:
03 February 2011 - 22 February 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to ISO and CIPAC guidelines and in compliance with GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: ISO 13320:2009
Deviations:
not specified
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
not specified
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): E-Y110
- Test substance storage: At room temperature protected from light
- Stability under storage conditions: Stable
- Description: Orange powder
- Batch: MB-1
- Expiry date: 23 December 2015

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
64.033 µm
Remarks on result:
other: average of 5 runs, result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean (% STDV MMAD=2.43) (migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Percentile:
D50
Mean:
48.967 µm
St. dev.:
1.36
Remarks on result:
other: average of 5 runs (see also remark MMAD)
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 6.757 µm
Distribution:
10 %
Remarks on result:
other: by volume of sample
No.:
#2
Size:
< 10 µm
Distribution:
15.15 %
Remarks on result:
other: by volume of sample
No.:
#3
Size:
< 48.967 µm
Distribution:
50 %
Remarks on result:
other: by volume of sample
No.:
#4
Size:
< 226.512 µm
Distribution:
90 %
Remarks on result:
other: by volume of sample

Any other information on results incl. tables

Visual and microscopic evaluation of the sample:

1. standard visual observation

- sample observed to be a medium and fine sized powder with small prticulates and lumps and clusters

2. microscope analysis (100x magnification)

- the particles appeared to be irregular shaped crystals

- the smallest individual particle size was approx. 3.2 µm and the largest individual size was approx. 256 µm

3. microscope analysis (400x magnification)

- sample was observed to be made up of both single and agglomerated crystalline particles

Applicant's summary and conclusion

Conclusions:
The MMAD of the test substance was determined to be 64.033 µm using Laser Diffraction Particle Size Analysis with a 'wet', small volume dispersion system. The median (D50) was determined as 48.967 µm. 15.15 % by volume of sample was seen to be < 10.00 µm.