2-Pyridinecarboxylic acid, 4-amino-3,6-dichloro-

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:

30 September 2015 to 26 October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

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:

18 µm

Remarks on result:

other: based on volume (%); 0.46 µm based on number (%) (No source field for Standard deviation.)

Percentile:

D10

Mean:

2.3 µm

Remarks on result:

other: based on volume (%)

Percentile:

D10

Mean:

0.34 µm

Remarks on result:

other: based on number (%)

Percentile:

D90

Mean:

65 µm

Remarks on result:

other: based on volume (%)

Percentile:

D90

Mean:

0.75 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)	2.3	0.34
d(0.5)	18	0.46
d(0.9)	65	0.75

The morphology of the particles was assessed under a microscope and the sample of test material was found to consist of a combination of irregular crystalline particles and cylindrical structures.

The 50 % quantile from the particle size distribution assessment of the test material was 18 µm based on the percentage volume and 0.46 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 18 µm based on the percentage volume and 0.46 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 45 mg) were dissolved in the chloroform dispersant (10 mL) and the resulting mixtures were shaken and transferred to the sampling tank. The samples were then sonicated for 1 minute 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 a combination of irregular crystalline particles and cylindrical structures.

Under the conditions of the study, the 50 % quantile from the particle size distribution assessment of the test material was 18 µm based on the percentage volume and 0.46 µm based on the percentage number.

Description of key information

MMD = 18 µm (based on percentage volume) and 0.46 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.

Under the conditions of the study, the 50 % quantile from the particle size distribution assessment of the test material was 18 µm based on the percentage volume and 0.46 µm based on the percentage number.