N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2015-03-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Laser light scattering. The test was performed according to the SOP - STR 071 Ed. 03 (Hydro 2000S-A) protocol.
The particle size distribution was analyzed using the Mastersizer 2000 tool, which uses the technique of laser diffraction to measure the size of particles. It measures the intensity of light scattered as a laser beam passes through a dispersed particulate sample. This data is then analyzed to calculate the size of the particles that created the scattering pattern.

This test was conducted on milled test material to be used for registration purposes only. The substance will not be put on the marlet in this form. The marketed material is either spray dried into micro-particles or mixed with deduster and hence has a distinctly higher particle size.

GLP compliance:

no

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Percentile:

D10

Mean:

ca. 3.564 µm

Remarks on result:

other: after 2 minutes of ultrasonic treatment

Percentile:

D50

Mean:

ca. 9.806 µm

Remarks on result:

other: after 2 minutes of ultrasonic treatment

Percentile:

D90

Mean:

ca. 25.254 µm

Remarks on result:

other: after 2 minutes of ultrasonic treatment

After 2 minutes of ultrasonic treatment.

Conclusions:

MD10 = 3.564 µm
MD50 = 9.806 µm
MD90 = 25.254 µm

Executive summary:

Method

The substance has been tested for granulometry by the volumetric distribution.

The particle size distribution was analyzed using the Mastersizer 2000 tool, which uses the technique of laser diffraction to measure the size of particles. It measures the intensity of light scattered as a laser beam passes through a dispersed particulate sample. This data is then analyzed to calculate the size of the particles that created the scattering pattern.

 

Results

MD10 = 3.564 µm

MD50 = 9.806 µm

MD90 = 25.254 µm

Reference 2

Endpoint:

particle size distribution (granulometry)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is marketed or used in a non solid or granular form

Description of key information

The granulometry study does not need to be conducted as the substance is marketed or used in a granular or dedusted form. The substance is either isolated by spray drying into the composite microgranular form or the wet press cake is mixed with dedusting agents prior to drying which form a coat around the dye particles and hence increase the particle size distinctly. As such, the particle size is not a function of the chemical but a function of the formulation procedure (spray dryer, dedusting, solution) used; a typical particle size distribution for dyes isolated as low dust granules is as follows: 10% < 123 µm; 25% < 159 µm; 50% < 207 µm; 75% < 266 µm; 90% < 326 µm.

The test substance used for regulatory testing is especially milled into small particles to enable a testing of the substance with sufficient exposure. It does not represent the particle size of the substance placed on the market.

The measured distribution of the milled substance is a follows:

MD10 = 3.564 µm

MD50 = 9.806 µm

MD90 = 25.254 µm

Additional information

The test substance used for regulatory testing is especially milled into small particles to enable a testing of the substance with sufficient exposure. It does not represent the particle size of the substance placed on the market.

The particle size distribution of the milled test substance was measured by laser light scattering. The test was performed according to the SOP - STR 071 Ed. 03 (Hydro 2000S-A) protocol.

The particle size distribution was analyzed using the Mastersizer 2000 tool, which uses the technique of laser diffraction to measure the size of particles. It measures the intensity of light scattered as a laser beam passes through a dispersed particulate sample. This data is then analyzed to calculate the size of the particles that created the scattering pattern.