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:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Technical Guidance Document EUR 20268 Determination of Particle Size Distribution
Version / remarks:
The method employed was based on a procedure designed to be compatible with that given in European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002).
Deviations:
no
Principles of method if other than guideline:
The determination was carried out using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).

GLP compliance:
yes
Type of method:
cascade impaction
Type of particle tested:
other: powder
Type of distribution:
mass based distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
(7-Methoxy-3,4-dihydronaphthalen-1-yl)acetonitrile
EC Number:
617-813-7
Cas Number:
861960-34-1
Molecular formula:
C13H13NO
IUPAC Name:
(7-Methoxy-3,4-dihydronaphthalen-1-yl)acetonitrile

Results and discussion

Mass median aerodynamic diameter:
< 100 µm
Particle size distribution at different passages
No.:
#1
Size:
< 100 µm
Distribution:
ca. 15.8 %

Applicant's summary and conclusion

Conclusions:
The proportion of test item having an inhalable particle size of less than 100 μm was determined to be 15.8% by sieve analysis. Cascade impactor analysis identified negligible content (<1.0%) of the test item had a particle size <10 μm.