4-[bis(phenylsubstituted)substituted]phthalic acid

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: 13 December 2017. Experimental completion date: 08 March 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

Test guideline 1

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

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Results and discussion

Remarks on result:

not determinable

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

84.7 %

Remarks on result:

other: inhalable particle size

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

<= 1.77 %

Remarks on result:

other: thoracic particle size

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

<= 0.301 %

Remarks on result:

other: respirable particle size

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)	13.73 g
Mass of test item passed through sieve (W3– W2)	11.63 g
Percentage of test item less than 10 µm	84.7%

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	1.77	0.84	0.32
Sample Cup 1	>10.0	1.4425	2.1063	2.6517
Sample Cup 2	5.5 to 10.0	0.0012	0.0337	0.0444
Sample Cup 3	2.4 to 10.0	0.0000	0.0047	0.0052
Sample Cup 4	1.61 to 2.4	0.0000	0.0019	0.0025
Sample Cup 5	0.307 to 1.61	0.0000	0.0002	0.0009
Final Filter	<0.307	0.0007	0.0004	0.0005
Total mass of collected test item		3.2144	2.9872	3.0252
Mass of test item added		3.2059	3.0241	3.0275

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	0.0019	0.0409	0.0535	0.059	1.37	1.77
<5.5	0.0007	0.0072	0.0091	0.022	0.241	0.301
<2.4	0.0007	0.0025	0.0039	0.022	0.084	0.129
<1.61	0.0007	0.0006	0.0014	0.022	0.020	0.046
<0.307	0.0007	0.0004	0.0005	0.022	0.013	0.017

Mean cumulative percentage with a particle size less than 10.0 µm : ≤ 1.77

Mean cumulative percentage with a particle size less than 5.5 µm : ≤ 0.301

Applicant's summary and conclusion

Conclusions:

Particle size data acquired for the test item gave the following results:
Percentage of test item with an inhalable particle size <100 µm: 84.7%
Percentage of test item with a thoracic particle size <10.0 µm : ≤1.77%
Percentage of test item with a respirable particle size <5.5 µm: ≤0.301%

Executive summary:

The determination was carried out using a procedure designed to be compatible with European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).

Particle size data acquired for the test item is showing in the following table:

Measurement	Method	Result
Percentage of test item with an inhalable particle size <100 µm	Sieve	84.7%
Percentage of test item with a thoracic particle size <10.0 µm	Cascade Impactor	≤1.77%
Percentage of test item with a respirable particle size <5.5 µm	Cascade Impactor	≤0.301%