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:
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:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
High speed image analysis
GLP compliance:
no
Type of method:
other: Image analysis
Remarks:
Sympatec QICPIC (0179 Q) & RODOS (injection disperser)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

Mass median aerodynamic diameter:
ca. 153 µm
Geometric standard deviation:
ca. 26
Particle sizeopen allclose all
Percentile:
D10
Mean:
ca. 22.9 µm
St. dev.:
3.27
Key result
Percentile:
D50
Mean:
ca. 152.79 µm
St. dev.:
25.62
Percentile:
D90
Mean:
ca. 785.22 µm
St. dev.:
376.04

Applicant's summary and conclusion

Conclusions:
The median diameter of the test substance particles was determined to be 153 µm.
Executive summary:

The following particle size distribution was determined for ascorbyl palmitate:

x10 = 23 µm

x50 = 153 µm (Median value)

x90 = 785 µm