Sodium naphthalene-2-carboxylate

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 16 May 2008 and 13 June 2008.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The work described was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).

Test material

Test material information

Constituent 1

Reference substance name:

Sodium naphthalene-2-carboxylate

EC Number:

700-038-4

Cas Number:

17273-79-9

Molecular formula:

C11 H7 Na O2

IUPAC Name:

Sodium naphthalene-2-carboxylate

Results and discussion

Particle size

Percentile:

D50

Mean:

other: Too few particles were of a size less than 10.0 µm to allow accurate assessment of mass median aerodynamic diameter.

Remarks on result:

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

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

33 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

1.76 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

0.372 %

Any other information on results incl. tables

Screening test (sieve method)

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

Sieve aperture size (µm)	100
Mass of test material transferred to sieve (g)	14.98
Mass of test material passed through sieve (g)	4.94
Test material less than sieve aperture size (%)	33.0

Definitive test (cascade impactor method)

Determination 1

The results of the cascade impactor method are shown in the following table:

    Determination 1

Cup Number	Particle Collected (µm)	Cup Masses (g)
		Pre-sampling	Post-sampling	Difference
1	>10.0	86.1066	88.9407	2.8341
2	5.5 - 10.0	85.4348	85.4790	0.0442
3	2.4 - 5.5	85.8883	85.8940	0.0057
4	1.61 - 2.4	85.5811	85.5835	0.0024
5	0.307 - 1.61	85.7488	85.7504	0.0016
Filter	0.307	75.0908	75.0923	0.0015

Amount of test material found in artificial throat: 0.09g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 2.98g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:       Determination 1

Cup Number	Particle Size Cut-points (µm)	Cumulative Mass of Test Material (g)	Cumulative Amount of Test Material (%)
2	10.0	0.0554	1.86
3	5.5	0.0112	0.376
4	2.4	0.0055	0.185
5	1.61	0.0031	0.104
Filter	0.307	0.0015	5.03 x 10^-2

Determination 2

The results of the cascade impactor method are shown in the following table:

      Determination 2

Cup Number	Particle Collected (µm)	Cup Masses (g)
		Pre-sampling	Post-sampling	Difference
1	>10.0	86.1076	88.9085	2.8009
2	5.5 - 10.0	85.4354	85.4728	0.0374
3	2.4 - 5.5	85.8895	85.8955	0.0060
4	1.61 - 2.4	85.5817	85.5848	0.0031
5	0.307 - 1.61	85.7495	85.7517	0.0022
Filter	0.307	75.0936	75.0951	0.0015

Amount of test material found in artificial throat: 0.15g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 3.00g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:     Determination 2

Cup Number	Particle Size Cut-points (µm)	Cumulative Mass of Test Material (g)	Cumulative Amount of Test Material (%)
2	10.0	0.0502	1.67
3	5.5	0.0128	0.427
4	2.4	0.0068	0.227
5	1.61	0.0037	0.123
Filter	0.307	0.0015	5.00 x 10^-2

Determination 3

The results of the cascade impactor method are shown in the following table:

      Determination 3

Cup Number	Particle Collected (µm)	Cup Masses (g)
		Pre-sampling	Post-sampling	Difference
1	>10.0	86.1083	88.9796	2.8713
2	5.5 - 10.0	85.4362	85.4793	0.0431
3	2.4 - 5.5	85.8900	85.8948	0.0048
4	1.61 - 2.4	85.5824	85.5843	0.0019
5	0.307 - 1.61	85.7501	85.7510	0.0009
Filter	<0.307	75.0916	75.0934	0.0018

Amount of test material found in artificial throat: 0.07g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 2.99g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown in the following table:

     Determination 3

Cup Number	Particle Size Cut-points (µm)	Cumulative Mass of Test Material (g)	Cumulative Amount of Test Material (%)
2	10.0	0.0525	1.75
3	5.5	0.0094	0.314
4	2.4	0.0046	0.154
5	1.61	0.0027	9.02 x 10^-2
Filter	0.307	0.0018	6.01 x 10^-2

The overall cumulative amounts of test material with a particle size less than 10.0 µm (%) from Determinations 1 to 3 are shown in the following table:

Determination	Cumulative Amount of Test Material Less Than 10.0 µm (%)	Mean Cumulative Amount of Test Material Less Than 10.0 µm (%)
1	1.86	1.76
2	1.67
3	1.75

The overall cumulative amounts of test material with a particle size less than 5.5 µm (%) from Determinations 1 to 3 are shown in the following table:

Determination	Cumulative Amount of Test Material Less Than 5.5 µm (%)	Mean Cumulative Amount of Test Material Less Than 5.5 µm (%)
1	0.376	0.372
2	0.427
3	0.314

Discussion

Too few particles were of a size less than 10.0 µm to allow accurate assessment of mass median aerodynamic diameter.

Representative sampling was ensured by rolling the sample container for approximately 10 minutes, and sampling from the top, middle and bottom prior to definitive testing.

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Conclusion

Particle size data acquired for the test material are shown in the following table:

Measurement		Method		Result
Proportion of test material having an inhalable particle size less than 100 µm		Sieve		33.0%
Proportion of test material having a thoracic particle size less than 10.0 µm		Cascade Impactor		1.76%
Proportion of test material having a respirable particle size less than 5.5 µm		Cascade Impactor		0.372%

Applicant's summary and conclusion

Conclusions:

Particle size data acquired for the test material are shown in the following table:

Measurement Method Result
Proportion of test material having an inhalable particle size less than 100 µm Sieve 33.0%
Proportion of test material having a thoracic particle size less than 10.0 µm Cascade Impactor 1.76%
Proportion of test material having a respirable particle size less than 5.5 µm Cascade Impactor 0.372%

Executive summary:

For substance Na-Na in project number 1307 -0436 the method used is designed to comply with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110.