Octasodium 2-(6-(4-chloro-6-(3-(N-methyl-N-(4-chloro-6-(3,5-disulfonato-2-naphthylazo)-1-hydroxy-6-naphthylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,5-disulfonato-1-hydroxy-2-naphthylazo)naphthalene-1,5-disulfonate

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

The aerodynamic particle size distribution of test substance was assessed by air elutriation using vertical elutriator. The amount of the test substance eluted from the starting material at range of air velocities (corresponding to an appropriate range of settling velocities and hence aerodynamic equivalent diameter (AED)), was measured on duplicate samples, allowing 30 minutes elutriation at each velocity.

GLP compliance:

yes

Type of method:

sedimentation (gravitational settling)

Type of particle tested:

primary particle

Type of distribution:

other: SIze shape and density

Specific details on test material used for the study:

Batch number: 3507/15
Purity: 66.9% w/w

Mass median aerodynamic diameter:

> 15 - < 115 µm

Remarks on result:

other: particle size range

Key result

Percentile:

other: 23.89%

Mean:

< 115 µm

Remarks on result:

other: upper limit

Remarks:

please check below table for further details

The results derived from the mean of the measurements taken using the elutriator were as follows

AED (µm)	Weight loss		mean weight loss (%)	mean accumulative loss (%)
	Sample 1	Sample 2
≤ 15	0	0	0	0
≤ 35	2.38	4.14	3.26	3.26
≤ 50	4.44	3.42	3.93	7.19
≤ 75	7.05	7.62	7.34	14.53
≤ 115	8.99	9.74	9.36	23.89

Conclusions:

Under the study conditions, the mass median aerodynamic diameter of the particles was determined to be in the range of 15 – 115 µm and the diameter of 23.8% of the particles was less than or equal to 115 µm.

Executive summary:

A study conducted to determine the particle size distribution of the substance using the air elutriation method, in compliance with GLP. Under the study conditions, the mass median aerodynamic diameter of the particles was determined to be in the range of 15 – 115 µm and the diameter of 23.8% of the particles was less than or equal to 115 µm (Parr-Dobrzanski, 1993).

Description of key information

The particle size distribution was determined using the air elutriation method (Parr-Dobrzanski, 1993).

Additional information

The mass median aerodynamic diameter of the particles was determined to be in the range of 15 – 115 µm and the diameter of 23.8% of the particles were less than or equal to 115 µm.