trans-cinnamic acid

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 27 April 2018 and 18 May 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

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)

Remarks:

Date of Inspection: 18/07/2017 - 20/07/2017 Date of Issue: 28/11/2017

Type of method:

cascade impaction

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Test material

Test material information

Constituent 1

Reference substance name:

trans-cinnamic acid

EC Number:

205-398-1

EC Name:

trans-cinnamic acid

Cas Number:

140-10-3

Molecular formula:

C9H8O2

IUPAC Name:

3-phenylacrylic acid

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
20171106
- Expiration date of the lot/batch:
10 April 2020

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Room temperature, in the dark, over silica gel

Results and discussion

Remarks on result:

not determinable because of methodological limitations

Remarks:

<0.292% of test item has a particle size <10.0 μm therefore it was not possible to determine MMAD or GSD

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

90.2 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

<= 0.292 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

<= 0.116 %

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)	12.26 g
Mass of test item passed through sieve (W3– W2)	11.06 g
Percentage of test item less than 100µm	90.2%

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
Artificial throat	n/a	1.24	0,88	1.50
Sample Cup 1	>10.0	1.8050	2.0459	1.5053
Sample Cup 2	5.5 to 10.0	0.0000	0.0003	0.0053
Sample Cup 3	2.4 to 5.5	0.0000	0.0000	0.0013
Sample Cup 4	1.61 to 2.4	0.0000	0.0000	0.0005
Sample Cup 5	0.307 to 1.61	0.0000	0.0000	0.0005
Final Filter	<0.307	0.0000	0.0000	0.0012
Total mass of collected test item		3.0450	2.9262	3.0141
Mass of test item		3.0418	2.9393	3.0312

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 Range Collected (μm)	Collected Mass (g)			Collective Percentage (%)
	Determination 1	Determination 2	Determination 3	Determination 1	Determination 2	Determination 3
<10.0	0.0000	0.0003	0.0088	0.00	0.01	0.292
<5.5	0.0000	0.0000	0.0035	0.00	0.00	0.116
<2.4	0.0000	0.0000	0.0022	0.00	0.00	0.073
<1.61	0.0000	0.0000	0.0017	0.00	0.00	0.056
<0.307	0.0000	0.0000	0.0012	0.00	0.00	0.040

Mean cumulative percentage with a particle size less than 10.0 μm :≤0.292

Mean cumulative percentage with a particle size less than 5.5 μm :≤0.116

Discussion

Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes and then sampling from the top, middle and bottom.

The overall results from the cascade impactor were taken as limit values due to the variation between the sampling positions; this gives a worst case scenario.

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:

The percentage of test item with an inhalable particle size <100 μm is 90.2%.
The percentage of test item with a thoracic particle size <10.0 μm is ≤0.292%
The percentage of test item with a respirable particle size <5.5 μm is ≤0.116%

Executive summary:

Particle size data was acquired, using a procedure 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:

The percentage of test item with an inhalable particle size <100 μm is 90.2%.

The percentage of test item with a thoracic particle size <10.0 μm is ≤0.292%

The percentage of test item with a respirable particle size <5.5 μm is ≤0.116%