Hexadecyltrimethylammonium toluene-p-sulphonate

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:

10-8-2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Qualifier:

equivalent or similar to guideline

Guideline:

other: Developmnet Methods based in ATM013

Principles of method if other than guideline:

Equipment: Fritch Analysette 3 spartan vibratory sieve shaker. various aperture sieves (stainless steel) 200 mm diameter

Method Conditions:
49.0-51.0 g analysed per test.
Shake = 15 mins, Amplitude = 3.0mm

GLP compliance:

not specified

Type of method:

sieving

Type of particle tested:

primary particle

Specific details on test material used for the study:

Sample 1
Name: CETATS
Batch no: 99M1061L
Date of manufacture: 29/3/2012
Sample Purity: >99.5%
Date of analysis: 24/5/2016

Sample 2
Name: CETATS
Batch no: 99D1100U
Date of manufacture: 24/4/2017
Sample Purity: 100.3%
Date of analysis: 24/5/2016

Mass median aerodynamic diameter:

100 µm

Percentile:

D90

Mean:

>= 100 µm

St. dev.:

0

Conclusions:

CETATS is a fine whte powder with the majority of particles being less than 300μm in size.
Based on the tested samples it is estomated that less than 20% of the powder is potentially inhalable fraction i.e. particle size of <100μm according to EN 481.

Description of key information

CETATS is a fine whte powder with the majority of particles being less than 300μm in size.

Based on the tested samples it is estomated that less than 20% of the powder is potentially inhalable fraction i.e. particle size of <100μm according to EN 481.