Reaction mass of Phosphorous(1+), (N-ethylethanaminato) diphenyl(phenylmethyl)-(T-4)-salt with 4, 4' - [2,2,2-trifluoro-1-(trifluoromethyl) ethylidene bis[phenol] (1:1) and (4,4'-[2,2,2-Trifluoro-1-(trifluoromethyl)ethylidene]diphenol

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:

May 2014 - July 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002)

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 3706OB
- Expiration date of the lot/batch: 3MArch 2019
- Purity test date: March 2014
- Purity: 99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark

Mass median aerodynamic diameter:

>= 5.5 - < 100 µm

No.:

#1

Size:

> 100 µm

Distribution:

29.6 %

No.:

#2

Size:

>= 5.5 - <= 10 µm

Distribution:

0.444 %

No.:

#3

Size:

<= 5.5 µm

Distribution:

0.021 %

The sieve analysis result was greater than 10% passing through the 100 μm sieve, therefore the sample was further characterized by cascade impactor. Representative sampling was performed by rolling the test item container for approximately 10 minutes and then sampling from the top, middle and bottom.

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Conclusions:

Proportion of test item having an inhalable particle size >100 μm was 29.6%
Proportion of test item having a thoracic particle size ≤10.0 μm was 0.444%
Proportion of test item having a respirable particle size ≤5.5 μm was 0.021%

Executive summary:

Particle size data was acquired, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002). The results are as follows:

Proportion of test item having an inhalable particle size >100 μm was 29.6% using the sieve method

Proportion of test item having a thoracic particle size ≤10.0 μm was 0.444% using the cascade impactor method

Proportion of test item having a respirable particle size ≤5.5 μm was 0.021% using the cascade impactor method

Description of key information

Particle size data was detremined, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002). No deviation from the guideline was observed during the study.

The results are as follows:

Proportion of test item having an inhalable particle size >100 μm was 29.6% using the sieve method

Proportion of test item having a thoracic particle size ≤10.0 μm was 0.444% using the cascade impactor method

Proportion of test item having a respirable particle size ≤5.5 μm was 0.021% using the cascade impactor method