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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study, compliant with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Principles of method if other than guideline:
Cascade impactor method
GLP compliance:
yes (incl. QA statement)
Type of distribution:
counted distribution

Test material

Constituent 1
Reference substance name:
ZO-1
IUPAC Name:
ZO-1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Sponsor's identification: ZO-1
Desription: white powder
Batch number: 0603
Storage conditions: room temperature, in the dark

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
> 10.2 µm
Distribution:
ca. 95.04 %
No.:
#2
Size:
> 0 - < 10.2 µm
Distribution:
ca. 4.96 %
No.:
#3
Size:
> 0 - < 5.4 µm
Distribution:
ca. 1.55 %

Any other information on results incl. tables

Screening test

The results of the sieving procedure (100µm sieve) are shown in the following table:

Mass of test material transferred to sieve (g): 15.45

Mass of test material passed through sieve (g): 12.87

Test material less than sieve aperture size (%): 83.3

Too few particles were of a size less than 10.2 µm to allow accurate assessment of mass median aerodynamic diameter.

Applicant's summary and conclusion

Conclusions:
Proportion of test material having an inhalable particle size less than 100 µm: 83.3 %.
Proportion of test material having a thoracic particle size less than 10.2 µm: 4.96 %
Proportion of test material having a respirable particle size less than 5.4 µm: 1.55 %
Executive summary:

The particle size distributio of the test substance was determined semi-quantitative using the sieve method as pretest and the cascade Impactor method.

The Particle size data acquired for the test material are shown in the following table:

Proportion of test material having an inhalable particle size less than 100 µm: 83.3 %.

Proportion of test material having a thoracic particle size less than 10.2 µm: 4.96 %

Proportion of test material having a respirable particle size less than 5.4 µm: 1.55 %

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