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Physical & Chemical properties

Particle size distribution (Granulometry)

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Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Guideline:
other: Air elutriation
Principles of method if other than guideline:
HSE, 2000 MDHS 14
ISO 7708:1995(E)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
454-140-6
EC Name:
-
Cas Number:
376608-71-8
Molecular formula:
C9H9F2N*C8H8O3
IUPAC Name:
trans-(1R,2S)-2-(3,4-difluorophenyl-cyclopropanaminium (2R)- 2-hydroxy-2-phenylethanoate
Constituent 2
Reference substance name:
trans-(1R,2S)-2-(3,4-difluorophenyl-cyclopropanaminium (2R)- 2-hydroxy-2-phenylethanoate
IUPAC Name:
trans-(1R,2S)-2-(3,4-difluorophenyl-cyclopropanaminium (2R)- 2-hydroxy-2-phenylethanoate

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:
<= 115 µm
Distribution:
4.12 %
No.:
#2
Size:
< 15 µm
Distribution:
0.13 %

Applicant's summary and conclusion

Conclusions:
It was apparent that some of the test substance was capable of becoming airborne under the conditions of the test, 4.12% being less than or equivalent to 115 µm aerodynamic equivalent diameter (AED).  Eluted material having an AED of less than 15 µm can be considered as respirable and represented 0.13% by weight. Therefore, C3RO is considered to be of very low inhalability and respirability.

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