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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EC guidance doc EUR 2086 'Determination of particle size distribution, fibre length and diameter distribution of chemical substances (2002)
Principles of method if other than guideline:
- Principle of test: Qualitative test to determine if substance meets definition of nano and percentage of respirable particles present;
- Short description of test conditions: Sieving using 100um mesh.
- Parameters analysed / observed: Percentage retained and passing sieve.
GLP compliance:
yes (incl. certificate)
Type of method:
sieving
Type of particle tested:
other: not specified
Type of distribution:
mass based distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sigma Aldrich, Batch no: MKBR8664V
- Expiration date of the lot/batch: 11/2/16
- Purity >99.9%

Results and discussion

Remarks on result:
not determinable
Remarks:
too few particles were of a size less than 100um to allow accurate assessment of the mass mean aerodynamic diameter.
Particle size distribution at different passages
No.:
#1
Size:
100 µm
Distribution:
0.74 %
Remarks on result:
other: quantity passing through sieve

Applicant's summary and conclusion

Executive summary:

The substance was determined to be essentially non-inhalable. It is not a nano-substance.