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
Study period:
February 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
other: powder
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
"Permethol" batch 8016 and 8021

Results and discussion

Mass median aerodynamic diameter:
>= 24.8 - <= 36.1 µm
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
>= 1.787 - <= 1.935 µm
St. dev.:
0.015
Key result
Percentile:
D50
Mean:
>= 9.068 - <= 15.55 µm
St. dev.:
0.16
Key result
Percentile:
D90
Mean:
>= 62.554 - <= 85.04 µm
St. dev.:
2.295
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 0.1 µm
Distribution:
0 %
No.:
#2
Size:
< 0.1 µm
Distribution:
0 %
No.:
#3
Size:
< 0.1 µm
Distribution:
0 %
No.:
#4
Size:
< 0.1 µm
Distribution:
0 %
No.:
#5
Size:
< 0.1 µm
Distribution:
0 %
No.:
#1
Size:
< 1 µm
Distribution:
5.06 %
No.:
#2
Size:
< 1 µm
Distribution:
4.99 %
No.:
#3
Size:
< 1 µm
Distribution:
4.97 %
No.:
#4
Size:
< 1 µm
Distribution:
5.08 %
No.:
#5
Size:
< 1 µm
Distribution:
5.01 %
No.:
#1
Size:
< 10 µm
Distribution:
39.05 %
No.:
#2
Size:
< 10 µm
Distribution:
38.56 %
No.:
#3
Size:
< 10 µm
Distribution:
38.64 %
No.:
#4
Size:
< 10 µm
Distribution:
39.42 %
No.:
#5
Size:
< 10 µm
Distribution:
38.91 %
No.:
#1
Size:
< 100 µm
Distribution:
93.06 %
No.:
#2
Size:
< 100 µm
Distribution:
92.23 %
No.:
#3
Size:
< 100 µm
Distribution:
91.79 %
No.:
#4
Size:
< 100 µm
Distribution:
92.86 %
No.:
#5
Size:
< 100 µm
Distribution:
91.63 %
No.:
#1
Size:
< 1 000 µm
Distribution:
100 %
No.:
#2
Size:
< 1 000 µm
Distribution:
100 %
No.:
#3
Size:
< 1 000 µm
Distribution:
100 %
No.:
#4
Size:
< 1 000 µm
Distribution:
100 %
No.:
#5
Size:
< 1 000 µm
Distribution:
100 %
No.:
#6
Size:
< 0.1 µm
Distribution:
0 %
No.:
#7
Size:
< 0.1 µm
Distribution:
0 %
No.:
#8
Size:
< 0.1 µm
Distribution:
0 %
No.:
#9
Size:
< 0.1 µm
Distribution:
0 %
No.:
#10
Size:
< 0.1 µm
Distribution:
0 %
No.:
#6
Size:
< 1 µm
Distribution:
5.11 %
No.:
#7
Size:
< 1 µm
Distribution:
5.13 %
No.:
#8
Size:
< 1 µm
Distribution:
5.1 %
No.:
#9
Size:
< 1 µm
Distribution:
5.05 %
No.:
#10
Size:
< 1 µm
Distribution:
5.13 %
No.:
#6
Size:
< 10 µm
Distribution:
53.36 %
No.:
#7
Size:
< 10 µm
Distribution:
53.63 %
No.:
#8
Size:
< 10 µm
Distribution:
53.25 %
No.:
#9
Size:
< 10 µm
Distribution:
52.84 %
No.:
#10
Size:
< 10 µm
Distribution:
53.32 %
No.:
#6
Size:
< 100 µm
Distribution:
93.97 %
No.:
#7
Size:
< 100 µm
Distribution:
93.88 %
No.:
#8
Size:
< 100 µm
Distribution:
93.96 %
No.:
#9
Size:
< 100 µm
Distribution:
93.6 %
No.:
#10
Size:
< 100 µm
Distribution:
93.95 %
No.:
#6
Size:
< 1 000 µm
Distribution:
100 %
No.:
#7
Size:
< 1 000 µm
Distribution:
100 %
No.:
#8
Size:
< 1 000 µm
Distribution:
100 %
No.:
#9
Size:
< 1 000 µm
Distribution:
100 %
No.:
#10
Size:
< 1 000 µm
Distribution:
100 %

Any other information on results incl. tables

acceptance criteria = acceptable according to ISO13320 -1

variation coefficient:

d10: 0.681 -0.934

d50: 0.827-1.577

d90: 1.927-3.980

Applicant's summary and conclusion

Conclusions:
D10 mean = 1.861
D50 mean = 12.309
D90 mean = 73.797

D[4,3]µm=33.93 and 25.037
Executive summary:

D10 mean = 1.861

D50 mean = 12.309

D90 mean = 73.797

D[4,3]µm=33.93 and 25.037

acceptance criteria = acceptable according to ISO13320 -1