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Diss Factsheets

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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: DIN 53734
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of distribution:
mass based distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
424-210-0
EC Name:
-
Cas Number:
23911-85-5
Molecular formula:
C29 H24 O7
IUPAC Name:
2-benzoyl-5-[3-(4-benzoyl-3-hydroxyphenoxy)-2-hydroxypropoxy]phenol

Results and discussion

Particle size
Key result
Percentile:
D90
Mean:
> 20 - < 250 µm
Remarks on result:
other: st. deviation not calculated
Particle size distribution at different passagesopen allclose all
No.:
#8
Size:
425 µm
Distribution:
< 97.5 %
No.:
#7
Size:
355 µm
Distribution:
< 91 %
No.:
#6
Size:
250 µm
Distribution:
< 79.1 %
No.:
#5
Size:
125 µm
Distribution:
< 61.7 %
No.:
#4
Size:
75 µm
Distribution:
< 51.7 %
No.:
#3
Size:
45 µm
Distribution:
< 26.9 %
No.:
#2
Size:
20 µm
Distribution:
< 1.49 %
No.:
#1
Size:
10 µm
Distribution:
< 0.995 %

Applicant's summary and conclusion

Conclusions:
The particle size distribution of FADEX HE 1819 PK was such that there were less than 1% of particles within the respirable range (10µm). The majority of particles were found to be distributed over the range 20 to 250 µm
Executive summary:

The air-jet sieve technique employed does not distinguish between agglomerates, aggregates, etc and single particles. As such the measured particle size distribution is not on an individual particle basis. Alternative techniques such as the Coulter-Counter method can provide a distribution on a single particle basis, however this would not give a true representation of inhalation potential because the test material is dispersed in a liquid medium. The air-jet sieve method is considered to give a more accurate reflection of inhalation potential in the working environment where the test material is more likely to form agglomerates, aggregates etc.