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

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

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.