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:
Conducted Nov 04, 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2017
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
QICPIC (0179 Q) & RODOS, 2.00 63.0 mm - M6 (5 ... 1705 μm)
GLP compliance:
no
Type of method:
microscopic examination
Type of particle tested:
other: not specified
Type of distribution:
counted distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity/Composition: SI-2665: pure Beta Carotene
Sample marking: SI-2665: B-Carotene crist. Lot WC0104101, WN 0480487

Results and discussion

Mass median aerodynamic diameter:
31 µm
Particle sizeopen allclose all
Percentile:
D10
Mean:
10.8 µm
St. dev.:
0.65
Percentile:
D50
Mean:
31.26 µm
St. dev.:
0.78
Percentile:
D90
Mean:
58.75 µm
St. dev.:
0.83

Applicant's summary and conclusion

Conclusions:
Particle size distribution:
Sympatec, QICPIC
X10 = 11 μm
X50 = 31 μm (Median value)
X90 = 59 μm