sodium 3-((2,3-dicyanophenyl)sulfonyl)propane-1-sulfonate

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Testing was conducted between 13th November 2012 to 6th March 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ISO 013320: 2009-10-01 Particle Size Analysis - Laser Diffraction Methods

Deviations:

no

GLP compliance:

yes

Type of method:

Laser scattering/diffraction

Test material

Test material information

Constituent 1

Reference substance name:

sodium 3-((2,3-dicyanophenyl)sulfonyl)propane-1-sulfonate

EC Number:

696-126-4

Cas Number:

886592-17-2

Molecular formula:

C11H9N2O5S2Na

IUPAC Name:

sodium 3-((2,3-dicyanophenyl)sulfonyl)propane-1-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Results and discussion

Mass median aerodynamic diameter:

47.926 µm

Particle size

Percentile:

D50

Mean:

78.278 µm

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Any other information on results incl. tables

Manual Sieving Particle Size Results.

see Table below for weight details after sieving and results. Manual sieve analysis indicated that 7% by weight of the test substance had a particle size of >2000pm.

Size (µm)	Sieve weight, g	Sieve plus Test Item weight, g	Test Item weight, g	% by weight
>2000	432.7	442.6	9.9	7.0
Size (µm)	Receiver weight, g	Receiver plus Test Item, g	Test Item weight, g
<2000	243.3	374.3	131	93.0
		TOTALS	140.9	100.0

Optical Microscopy Particle Size Results

Direct Observation - the test substance was observed to be fine white powder, with larger agglomerates present. Under a light microscope with 10x magnification - the particles appeared to be mostly irregularly shaped (no lines of symmetry) with fibres, granulates or particles present.

Laser Diffraction Particle Size Results

Test Results (µm):

	RUN 1	RUN 2	RUN 3	RUN 4	RUN 5	** Average
Volume weighted mean	78.382	77.984	77.390	77.017	80.653	78.285
Median (d.50)	57.737	57.618	57.709	57.043	58.446	57.711
Mode	80.220	80.117	80.410	79.309	80.193	80.050
MMAD (Mass Median Aerodynamic Diameter)	47.948	47.849	47.925	47.372	48.537	47.926
10 % of the material is <	7.971	7.940	7.946	7.860	8.013	7.946
50 % of the material is <	57.737	57.618	57.709	57.043	58.446	57.711
90 % of the material is <	164.587	165.295	162.431	162.123	173.276	165.542

*Mass Median Aerodynamic Diameter (Density determined to be 1.45, and shape factor≈ 1)

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

The MMAD is calculated using the equation below:

MMAD  =VMD/ρ0.5*χ

   

ρ=Density (1.45, determined on Section 3.3)

χ=shape factor (assumed to be≈ 1)

 

Standard Deviation Results:

	1	2	3	4	5	STDVP	% STDV
d10	7.971	7.940	7.946	7.860	8.013	0.050	0.630
d50	57.737	57.618	57.709	57.043	58.446	0.446	0.773
d90	164.587	165.295	162.431	162.123	173.276	4.054	2.449
MMAD	47.948	47.849	47.925	47.372	48.537	0.371	0.773

 

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

Applicant's summary and conclusion

Conclusions:

A Manual sieve analysis indicated that 7% by weight of the Test Item had a particle size of >2000µm. A subsequent laser diffraction analysis on the <2000µm sample produced the following results:

Average (µm)
Volume weighted mean 78.285
Median (d.50) 57.711
Mode 80.050
MMAD (Mass Median Aerodynamic Diameter)* 48.092
10 % of the material is < 7.946
50 % of the material is < 57.711
90 % of the material is < 165.542
*Mass Median Aerodynamic Diameter (Density determinedto be 1.44, and shape factor ≈ 1)

Executive summary:

Introduction

The methods used are designed to comply with that given in 'Particle size distribution , fibre length and diameter distribution ' , June 1996 European commision technical guidance document , which satisfies the requirements of the OECD guideline 110.

Results and Conclusion

A Manual sieve analysis indicated that 7% by weight of the Test Item had a particle size of >2000µm. A subsequent laser diffraction analysis on the <2000µm sample produced the following results:

 

	Average (µm)
10 % of the material is <	7.946
50 % of the material is <	57.711
90 % of the material is <	165.542