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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 March 2016 to 25 September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
other: European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002).
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
other: cascade impaction and sieving
Specific details on test material used for the study:
- Purity: This substance has an Unknown or Variable composition, is a Complex reaction product, or a Biological material (UVCB).
- Description: Yellow powder
- Storage: Room temperature in the dark
Remarks on result:
other: See below for results.

Measurement

Method

Result

Proportion of test item having an inhalable particle size <100 μm

Sieve

38.6%

Proportion of test item having a thoracic particle size <10.0 μm

Cascade Impactor

0.012%

Proportion of test item having a respirable particle size <5.5 μm

Cascade Impactor

0.010%

Conclusions:
Under the conditions of the study, the particle size distribution of the test material was determined as follows; the proportion of the test material having an inhalable particle size of <100 µm was concluded to be 38.6%, via the sieve method. The proportion of test material having a thoracic particle size of <10.0 μm was determined via the cascade impactor to be 0.012%, and the proportion of test material having a respirable particle size of <5.5 μm to be 0.010%.
Executive summary:

Under the conditions of the study, the particle size distribution of the test material was determined as follows; the proportion of the test material having an inhalable particle size of <100 µm was concluded to be 38.6%, via the sieve method. The proportion of test material having a thoracic particle size of <10.0 μm was determined via the cascade impactor to be 0.012%, and the proportion of test material having a respirable particle size of <5.5 μm to be 0.010%. The procedure was 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).

Description of key information

Under the conditions of the study, the particle size distribution of the test material was determined as follows; the proportion of the test material having an inhalable particle size of <100 µm was concluded to be 38.6%, via the sieve method. The proportion of test material having a thoracic particle size of <10.0 μm was determined via the cascade impactor to be 0.012%, and the proportion of test material having a respirable particle size of <5.5 μm to be 0.010%. The procedure was 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).

Additional information