Sodium glyoxylate

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental starting date: 28 March 2017. Experimental completion date: 22 June 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: European Commission 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

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

Sodium glyoxylate

EC Number:

220-298-8

EC Name:

Sodium glyoxylate

Cas Number:

2706-75-4

Molecular formula:

C2H2O3.Na

IUPAC Name:

sodium oxoacetate

Specific details on test material used for the study:

Identification: Safelink SPM-01
Appearance/Physical state: colorless to slightly yellow powder
Batch: G150201
Purity: 99.9%
Expiry date: not supplied
Storage conditions: room temperature, in the dark

Results and discussion

Particle size

Key result

Percentile:

other: D18.5

Mean:

< 100 µm

St. dev.:

0

Any other information on results incl. tables

Sieve Screening Test

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

Measurement	Result
Mass of test item transferred to sieve (W1)	20.06 g
Mass of test item passed through sieve (W3 – W2)	3.72 g
Percentage of test item less than 100 μm	18.50%

Cascade Impactor

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

Collection Stage	Particle Size Range Collected (μm)	Collected Mass (g)
		Determination 1	Determination 2	Determination 3
Artifical throat	n/a	0.2	0.04	0.2
Sample cup 1	>10.0	2.6895	2.8911	2.7979
Sample cup 2	5.5 to 10.0	0.0483	0.0378	0.041
Sample cup 3	2.4 to 5.5	0.0053	0.006	0.0052
Sample cup 4	1.61 to 2.4	0.0004	0.0013	0.0006
Sample cup 5	0.307 to 1.61	0.0006	0.0006	0.0008
Final Filter	<0.307	0.0013	0.002	0.0012
Total mass of collected test item		2.9454	2.9788	3.0467
Mass of test item added		3.0244	3.0525	3.0864

The cumulative amounts of test item collected in the three determinations for the individual

particle size cut-points are shown in the following table:

Particle Size Cut points (μm)	Cumulative Mass (g)			Cumulative Percentage (%)
	Determination 1	Determination 2	Determination 3	Determination 1	Determination 2	Determination 3
<10.0	0.0559	0.0477	0.0488	1.9	1.6	1.6
<5.5	0.0076	0.0099	0.0078	0.258	0.332	0.256
<2.4	0.0023	0.0039	0.0026	0.078	0.131	0.085
<1.61	0.0019	0.0026	0.002	0.065	0.087	0.066
<0.307	0.0013	0.002	0.0012	0.044	0.067	0.039

Mean cumulative percentage with a particle size less than 10.0 μm : 1.70

Mean cumulative percentage with a particle size less than 5.5 μm : 0.282

Discussion

Sampling for the cascade impactor determinations was performed by rolling the test item

container for approximately 10 minutes then sampled from the top, middle and bottom.

Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass

median aerodynamic diameter.

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.

Applicant's summary and conclusion

Conclusions:

Particle size dat acquired for the test item is:
Percentage of test item with an inhalable particle size <100 μm: 18.5% (sieve method)
Percentage of test item with a thoracic particle size <10.0 μm: 1.70% (Cascade Impactor method)
Percentage of test item with a respirable particle size <5.5 μm 0.282% (Cascade Impactor method)

Executive summary:

Particle size data was acquired, 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). The results are as follows:

Measurement	Method	Result
Percentage of test item with an inhalable particle size <100 μm	Sieve	18.50%
Percentage of test item with a thoracic particle size <10.0 μm	Cascade Impactor	1.70%
Percentage of test item with a respirable particle size <5.5 μm	Cascade Impactor	0.28%