sodium 3-[(3,4-dicyanophenyl)thio]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:

2013-04-02 to 2013-04-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Meets the criteria for classification as reliable without restriction according to Klimisch et al (1997).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: European Commission Technical Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Test material

Test material information

Constituent 1

Reference substance name:

lithium 3-((3,4-dicyanophenyl)thio)propane-1-sulfonate

EC Number:

700-787-7

Cas Number:

769953-18-6

Molecular formula:

C11H9N2O3S2Li

IUPAC Name:

lithium 3-((3,4-dicyanophenyl)thio)propane-1-sulfonate

Results and discussion

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

30.4 %

Remarks on result:

other: Sieving

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

0.237 %

Remarks on result:

other: Cascade impactor

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

0.115 %

Remarks on result:

other: Cascade Impactor

Any other information on results incl. tables

    Sieving Screening Test

The results of the sieving procedure are shown in the following table:

 

Measurement	Result
Mass of test item transferred to sieve	19.18 g
Mass of test item passed through sieve	5.84 g
Proportion of test item <100 µm	30.4%

 

 

 Cascade Impactor Method

The results of the cascade impactor method determinations are shown as follows:

 

Determination 1

 

Collection Stage	Particle Size Range Collected (µm)	Mass (g)
		Pre-sampling	Post-sampling	Difference
Cup 1	>10.0	86.0864	88.6536	2.5672
Cup 2	5.5 to 10.0	85.5394	85.5443	0.0049
Cup 3	2.4 to 5.5	85.8837	85.8849	0.0012
Cup 4	1.61 to 2.4	85.6975	85.6983	0.0008
Cup 5	0.307 to 1.61	85.8700	85.8705	0.0005
Filter	<0.307	75.4724	75.4725	0.0001

 

Mass of test item found in artificial throat: 0.40 g.
Total mass of test item recovered from artificial throat, sample cups and filter: 2.9747 g.

Determination 2

 

Collection Stage	Particle Size Range Collected (µm)	Mass (g)
		Pre-sampling	Post-sampling	Difference
Cup 1	>10.0	86.0847	88.3475	2.2628
Cup 2	5.5 to 10.0	85.5373	85.5396	0.0023
Cup 3	2.4 to 5.5	85.8824	85.8834	0.0010
Cup 4	1.61 to 2.4	85.6953	85.6961	0.0008
Cup 5	0.307 to 1.61	85.8666	85.8676	0.0010
Filter	<0.307	75.4745	75.4749	0.0004

 

Mass of test item found in artificial throat: 0.69 g.
Total mass of test item recovered from artificial throat, sample cups and filter: 2.9583 g.

 

Determination 3

 

Collection Stage	Particle Size Range Collected (µm)	Mass (g)
		Pre-sampling	Post-sampling	Difference
Cup 1	>10.0	86.0844	88.7771	2.6927
Cup 2	5.5 to 10.0	85.5369	85.5406	0.0037
Cup 3	2.4 to 5.5	85.8818	85.8835	0.0017
Cup 4	1.61 to 2.4	85.6947	85.6960	0.0013
Cup 5	0.307 to 1.61	85.8665	85.8676	0.0011
Filter	<0.307	75.4752	75.4756	0.0004

 

Mass of test item found in artificial throat: 0.29 g.
Total mass of test item recovered from artificial throat, sample cups and filter: 2.9909 g.

 

Cumulative amounts

The cumulative amounts of test item found in the three determinations for the individual particle size cut-points are shown in the following table:

 

Particle Size Cut-point (µm)	Cumulative Mass (g)			Cumulative Percentage (%)
	Determination 1	Determination 2	Determination 3	Determination 1	Determination 2	Determination 3
10.0	0.0075	0.0055	0.0082	0.252	0.186	0.274
5.5	0.0026	0.0032	0.0045	8.74 x 10^-2	0.108	0.150
2.4	0.0014	0.0022	0.0028	4.71 x 10^-2	7.44 x 10^-2	9.36 x 10^-2
1.61	0.0006	0.0014	0.0015	2.02 x 10^-2	4.73 x 10^-2	5.02 x 10^-2
0.307	0.0001	0.0004	0.0004	3.36 x 10^-3	1.35 x 10^-2	1.34 x 10^-2

 

The overall cumulative percentage (%) of test item with a particle size less than 10.0 µm and 5.5 µm are shown in the following table:

 

 

Particle size	Cumulative Percentage (%)
	Determination 1	Determination 2	Determination 3	Mean
<10.0 µm	0.252	0.186	0.274	0.237
<5.5 µm	8.74 x 10^-2	0.108	0.150	0.115

 

Applicant's summary and conclusion

Conclusions:

The proportion of the test material that can be inhaled by the mouth or nose was determined to be 30.4%. The proportion of test material that is capable of passing the larynx was determined to be 0.237% and the proportion that is capable of reaching the alveoli was determined to be 0.115%.

Executive summary:

Introduction

This study was undertaken to determine the particle size distribution of the test material. The test method used was designed to be compatible with the European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).

Results & Conclusion

Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter. The proportion of the test material that can be inhaled by the mouth or nose was determined to be 30.4%. The proportion of test material that is capable of passing the larynx was determined to be 0.237% and the proportion that is capable of reaching the alveoli was determined to be 0.115%.