N-[[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]carbamoyl]-2,6-difluorobenzamide

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 September 2015 - 26 October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline, and the study was conducted under GLP conditions.

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Key result

Percentile:

D50

Mean:

10 µm

Remarks on result:

other: based on volume (%); 0.51 µm based on number (%)(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

Key result

Percentile:

D10

Mean:

1.2 µm

Remarks on result:

other: based on volume (%)

Key result

Percentile:

D10

Mean:

0.36 µm

Remarks on result:

other: based on number (%)

Key result

Percentile:

D90

Mean:

41 µm

Remarks on result:

other: based on volume (%)

Key result

Percentile:

D90

Mean:

0.93 µm

Remarks on result:

other: based on number (%)

Table 1: A summary of the 10, 50 and 90 % quantile results

Quantile	Size (µm)
	Based on volume (%)	Based on number (%)
d(0.1)	1.2	0.36
d(0.5)	10	0.51
d(0.9)	41	0.93

The morphology of the particles was assessed under a microscope and the sample of test material was found to consist of widely spread irregular shaped particles which were mostly oval shaped.

The 50 % quantile from the particle size distribution assessment of the test material was 10 µm based on the percentage volume and 0.51 µm based on the percentage number.

Conclusions:

Under the conditions of the study, the 50 % quantile from the particle size distribution assessment of the test material was 10 µm based on the percentage volume and 0.51 µm based on the percentage number.

Executive summary:

The particle size distribution of the test material was assessed in a study conducted in accordance with the standardised guideline CIPAC MT 187 under GLP conditions.

The size distribution of particles was assessed using particle size apparatus based on laser diffraction. Duplicate portions of the test material (approximately 70 mg) were dissolved in the heavy distillate dispersant (10 mL) and the resulting mixtures were shaken and transferred to the sampling tank. The samples were then sonicated for 2 minutes prior to measurement. For each sample, two measurements were taken 20 seconds apart and the mean data was calculated.

The morphology of the particles was assessed under a microscope and the sample of test material was found to consist of widely spread irregular shaped particles which were mostly oval shaped.

Under the conditions of the study, the 50 % quantile from the particle size distribution assessment of the test material was 10 µm based on the percentage volume and 0.51 µm based on the percentage number.

Description of key information

MMD = 10 µm (based on percentage volume) and 0.51 µm (based on percentage number), CIPAC MT 187, Comb (2015)

Additional information

The particle size distribution of the test material was assessed in a study conducted in accordance with the standardised guideline CIPAC MT 187 under GLP conditions. The study was assigned a reliability score of 1 in line with the criteria of Klimisch et al. (1997).

The size distribution of particles was assessed using particle size apparatus based on laser diffraction. Duplicate portions of the test material (approximately 70 mg) were dissolved in the heavy distillate dispersant (10 mL) and the resulting mixtures were shaken and transferred to the sampling tank. The samples were then sonicated for 2 minutes prior to measurement. For each sample, two measurements were taken 20 seconds apart and the mean data was calculated.

The morphology of the particles was assessed under a microscope and the sample of test material was found to consist of widely spread irregular shaped particles which were mostly oval shaped.

Under the conditions of the study, the 50 % quantile from the particle size distribution assessment of the test material was 10 µm based on the percentage volume and 0.51 µm based on the percentage number.