Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24th July 2017 to the 20th November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Qualifier:
according to
Guideline:
other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).
Principles of method if other than guideline:
Intended to provide a procedure for the study of the airborne dust and the nature of the dust produced for water soluble compounds.
GLP compliance:
yes (incl. certificate)
Type of method:
cascade impaction
Type of particle tested:
primary particle

Test material

Reference
Name:
Unnamed
Test material form:
solid: crystalline
Details on test material:
Expiry date:01 February 2021
Storage conditions: Room temperature in the dark
Batch 21-16131
Specific details on test material used for the study:
Identification:
2,5-diphenyloxazole
Appearance/Physical state:
White crystalline powder
Batch:
21-16131
Purity:
99.9%
Expiry date:
01 February 2021
Storage conditions:
Room temperature, in the dark

Results and discussion

Particle size
Key result
Remarks on result:
not measured/tested
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
ca. 60.9 %
No.:
#2
Size:
< 10 µm
Distribution:
< 0.35 %
No.:
#3
Size:
< 5.5 µm
Distribution:
< 0.06 %

Any other information on results incl. tables

The overall results from the cascade impactor were taken as limit values due to the variation between the sampling positions; this gives a worst case scenario.

Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.

Applicant's summary and conclusion

Conclusions:
The substance (2,5-diphenyloxazole) particle size was studied in accordance withEuropean Commission Guidance Document EUR 20268 via a GLP-certified laboratory. The study used the cascade impactor method and determined that the substance particle size was 60.9% less than 100 μm, <0.35 % less than 10μm and <0.06 % less than 5.5 μm respectively. Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
Executive summary:

The substance (2,5-diphenyloxazole) particle size was studied in accordance withEuropean Commission Guidance Document EUR 20268 via a GLP-certified laboratory. During the determinations, air was drawn through the cascade impactor by a vacuum pump at a flow rate of approximately 60 L/min for approximately 30 seconds. The air flow enters the impactor through a throat and inlet tube and then accelerates through the multiple stages. At each stage one or more nozzles direct the particle-laden airstream into a collection cup.

Particles larger than the cut size of a stage, impact onto the collection plate and stay in the collection cup. Smaller particles follow the airstream and are carried to the next stage. In succeeding stages the nozzles are smaller, the air velocity is higher and finer particles are collected. In the final stage the smallest particles are collected on a glass fibre filter. The mass of the artificial throat, collection cups and filter were recorded before and after each determination. The overall results from the cascade impactor were taken as limit values due to the variation between the sampling positions; this gives a worst case scenario.

The study used the cascade impactor method and determined that the substance particle size was 60.9% less than 100 μm, <0.35 % less than 10μm and <0.06 % less than 5.5 μm respectively. Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.