Reaction mass of benzoyl chloride, toluoyl chloride and 2-methyl resorcinol

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2022

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes

Type of method:

cascade impaction

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of benzoyl chloride, toluoyl chloride and 2-methyl resorcinol

Molecular formula:

not applicable

IUPAC Name:

Reaction mass of benzoyl chloride, toluoyl chloride and 2-methyl resorcinol

Test material form:

solid: particulate/powder

Details on test material:

Appearance: beige powder

Results and discussion

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 10 µm

Distribution:

<= 2.16 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 5.5 µm

Distribution:

<= 0.42 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 2.4 µm

Distribution:

<= 0.16 %

Particle size distribution at different passages 4

No.:

#4

Size:

< 1.61 µm

Distribution:

<= 0.06 %

Particle size distribution at different passages 5

No.:

#5

Size:

< 0.307 µm

Distribution:

<= 0.01 %

Any other information on results incl. tables

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

Table 2

Measurement	Result
Mass of test item transferred to sieve (W1)	15.00 g
Mass of test item passed through sieve (W3 – W2)	4.27 g
Percentage of test item less than 100 µm	28.5 %

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

Table 3

Collection Stage	Particle Size Range Collected (µm)	Collected Mass (g)
		Determination 1	Determination 2	Determination 3
Artificial throat	n/a	0.29	0.16	0.15
Sample Cup 1	≥10.0	2.7924	2.9177	2.7379
Sample Cup 2	≥5.5 to <10.0	0.0046	0.0062	0.0512
Sample Cup 3	≥2.4 to <5.5	0.0005	0.0005	0.0076
Sample Cup 4	≥1.61 to <2.4	0.0000	0.0004	0.0030
Sample Cup 5	≥0.307 to <1.61	0.0002	0.0003	0.0014
Final Filter	<0.307	0.0001	0.0001	0.0004
Total mass of collected test item		3.0878	3.0852	2.9515
Mass of test item added		3.0953	3.0916	3.0357

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

Table 4

Particle Size Cut Points (µm)	Cumulative Mass (g)			Cumulative Percentage (%)
	Determination 1	Determination 2	Determination 3	Determination 1	Determination 2	Determination 3
<10.0	0.0054	0.0075	0.0636	0.175	0.243	2.155
<5.5	0.0008	0.0013	0.0124	0.026	0.042	0.420
<2.4	0.0003	0.0008	0.0048	0.010	0.026	0.163
<1.61	0.0003	0.0004	0.0018	0.010	0.013	0.061
<0.307	0.0001	0.0001	0.0004	0.003	0.003	0.014

Overall cumulative percentage with a particle size less than 10.0 μm : ≤2.16
Overall cumulative percentage with a particle size less than 5.5 μm : ≤0.420

Applicant's summary and conclusion

Conclusions:

The percentage of test item with an inhalable particle size <100 µm using Sieve method was 28.5 %. The percentage of test item with a thoracic particle size <10.0 µm using Cascade Impactor was =2.16%, the percentage of test item with a respirable particle size <5.5 µm was shown to be =0.42%.