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Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

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Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: OECD 403
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU Method B.2
Deviations:
no
Principles of method if other than guideline:
The particle size distribution of the test material was determined using a Mercer 7 stage cascade impactor (Model 02-130, In-Tox . Products Inc, Alberquerque, New Mexico, USA) via gravimetric analysis of the test item deposited on each stage of the cascade impactor.
MMAD and GSD were calculated.
GLP compliance:
yes (incl. QA statement)
Type of method:
cascade impaction
Type of distribution:
counted distribution
Mass median aerodynamic diameter:
> 2.56 - < 2.79 µm
Percentile:
D50
Mean:
> 2.56 - < 2.79 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Conclusions:
The mass median diameter of the particles was > 2.56 and < 2.79µm.
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
The determination of particle size was made by a screening process with a specific mesh size in an air jet made by subpressure.
GLP compliance:
no
Type of method:
sieving
Type of distribution:
volumetric distribution
No.:
#1
Size:
< 100 µm
Distribution:
>= 15 %
Conclusions:
The particle size distribution shows that ≥15% of particles were < 100µm in diameter. Therefore, the Particle size distribution indicates substance is an inhalation risk (a significant proportion of the particles are present at < 100 µm).

Description of key information

Particle Size Distribution: > 15 % Particles < 100 µm (Weight of Evidence)

Additional information

The substance is manufactured as a powder. The available data indicate that the substance contains 15% particles < 100 µm in diameter and therefore, the substance is considered to be inhalable (Schongart (2010), Schuler (2010)).