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Diss Factsheets

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:
08 Jan 2013 - 05 Feb 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In accordance with GLP and well characterised substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: ISO 13320:2009 and CIPAC MT 187
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Principles of method if other than guideline:
laser diffraction
GLP compliance:
yes
Remarks:
2004/10/EC plus OECD
Type of method:
Laser scattering/diffraction
Type of distribution:
mass based distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
3,20-bis(ethylenedioxy)pregna-5,7-diene
EC Number:
243-175-0
EC Name:
3,20-bis(ethylenedioxy)pregna-5,7-diene
Cas Number:
19592-55-3
Molecular formula:
C25H36O4
IUPAC Name:
(1S,3aR,9aR,9bS,11aS)-9a,11a-dimethyl-1-(2-methyl-1,3-dioxolan-2-yl)-1,2,3,3a,6,8,9,9a,9b,10,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolane]
Test material form:
solid: crystalline
Details on test material:
Slightly yellow powder.

Results and discussion

Mass median aerodynamic diameter:
247.4 µm
Geometric standard deviation:
>= 0.03 - <= 0.78
Particle sizeopen allclose all
Percentile:
D10
Mean:
30.581 µm
St. dev.:
0.22
Percentile:
D50
Mean:
222.975 µm
St. dev.:
2.38
Percentile:
D90
Mean:
874.227 µm
St. dev.:
5.16
Percentile:
other: d15.78
Mean:
55.921 µm
St. dev.:
0.42
Percentile:
other: volume of sample < 10 um
Mean:
3.09 other: %
Remarks on result:
other: volume of sample <10um

Any other information on results incl. tables

 

RUN1             RUN2       RUN3       RUN4       RUN5      **Average

Volume weighted Mean     354.480      355.505       354.993      352.557       352.319          353.971

Median (d.50)                      216.424      219.607     222.757      220.209       222.975         220.402

Mode(µm)                           197.766       194.750     243.259       259.700       273.065         233.705

*MMAD                                 242.935       246.508      250.044      247.184       250.289        247.400

10% of material is <            30.105       30.602         30.688         30.294        30.581          30.453

50% of material is <          216.424      219.607        222.757     220.209       222.975        220.402

90% of material is  <         891.344       884.275     878.816        878.768     874.227        881.492

 

All results are in µm

*Mass Median Aerodynamic  Diameter

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

3.09% by volume of sample was seen to be <  10.00µm

Applicant's summary and conclusion

Conclusions:
The test substance MMAD (Mass Median Aerodynamic  Diameter) was reported at  247.400 um and 3.09% of volume of sample is less than < 10 um.
Executive summary:

 Summary of results


Particle Size Analysis using small volume (wet) module (SVM).       Average (µm)

Volume  weighted mean                                                               353.971

Median  (d.50)                                                                               220.402

Mode                                                                                              233.705

MMAD (Mass Median Aerodynamic  Diameter)                            247.400

10% of material is <     (d10)                                                            30.453

50% of material is <       (d50)                                                         220.402

90% of material  is <       (d90)                                                            881.492

volume of sample.< 10.00 µm                                                                      3.09 %