4-[(2E)-3-(3,5-dichloro-4-fluorophenyl)-4,4,4-trifluorobut-2-enoyl]-N-[(4R)-2-ethyl-3-oxo-1,2-oxazolidin-4-yl]-2-methylbenzamide

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

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EUR 20268

Version / remarks:

European Commission Technical Guidance Document '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:

mass based distribution

Test material

Test material information

Constituent 1

Reference substance name:

4-[3-(3,5-dichloro-4-fluorophenyl)-4,4,4-trifluorobut-2-enoyl]-N-(2-ethyl-3-oxo-1,2-oxazolidin-4-yl)-2-methylbenzamide

Molecular formula:

C23H18Cl2F4N2O4

IUPAC Name:

4-[3-(3,5-dichloro-4-fluorophenyl)-4,4,4-trifluorobut-2-enoyl]-N-(2-ethyl-3-oxo-1,2-oxazolidin-4-yl)-2-methylbenzamide

Test material form:

solid

Details on test material:

Off-white

Results and discussion

Mass median aerodynamic diameter:

1.96 µm

Geometric standard deviation:

2.47

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 10.4 µm

Distribution:

98.2 %

Remarks on result:

other: Cumulative fraction less than cut point

Particle size distribution at different passages 2

No.:

#2

Size:

< 7.7 µm

Distribution:

90.1 %

Remarks on result:

other: Cumulative fraction less than cut point

Particle size distribution at different passages 3

No.:

#3

Size:

< 4.1 µm

Distribution:

71.3 %

Remarks on result:

other: Cumulative fraction less than cut point

Particle size distribution at different passages 4

No.:

#4

Size:

< 1.3 µm

Distribution:

40.9 %

Remarks on result:

other: Cumulative fraction less than cut point

Particle size distribution at different passages 5

No.:

#5

Size:

< 0.9 µm

Distribution:

19.9 %

Remarks on result:

other: Cumulative fraction less than cut point

Particle size distribution at different passages 6

No.:

#6

Size:

< 0.56 µm

Distribution:

8.2 %

Remarks on result:

other: Cumulative fraction less than cut point

Applicant's summary and conclusion

Conclusions:

The mass median aerodynamic diameter of the sample of test material was determined to be 1.96 μm, and the geometric standard deviation was 2.47 μm.

Executive summary:

The particle size distribution of the test substance was determined under GLP to European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002). A dust atmosphere was produced from the test substance using a solid aerosol generator located adjacent to the cylindrical atmosphere chamber, which had a volume of 30 L (28 cm diameter x 50 cm height). The concentration of test substance aerolised within the chamber was controlled by adjusting the test substance feed. The actual chamber concentration was measured at the time of atmosphere generation with a gravimetric method using glass fiber filters placed in a holder, which was temporarily sealed in a vacant port in the chamber. A suitable, known volume of air was then drawn through the filter using a vacuum pump. Each filter was weighed before and after sampling in order to calculate the weight of collected test substance. The difference in the two weights, divided by the volume of air sampled, gave the actual chamber concentration. The flow of air containing the test substance into the chamber was adjusted until a suitable air concentration was achieved, and the actual measured concentrations in the two tests to determine the particle size distribution were 3.28 and 2.73 mg/L. The particle size distribution in two independent tests was determined using a Marple Personal Cascade Impactor (Westech IS Ltd, Beds, UK), consisting of a series of impactor stages with stainless steel collection substrates and a backup glass fiber filter, housed in aluminium samplers. Also these samplers were temporarily sealed in a sampling port in the atmosphere chamber and a suitable, known volume of air was drawn through it using a vacuum pump. The collection substrates and backup filter were weighed before and after sampling and the weight of test substance, collected at each stage, was calculated by difference. The particle size distribution, on a percentage mass basis, could then be determined and the mass median aerodynamic diameter (MMAD) and the geometric standard deviation (GSD) were calculated. The MMAD calculated from the two measurements was 1.96 μm and the GSD was 2.47 μm.