Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

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:
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.

Additional information