Registration Dossier

Administrative data

Endpoint:
nanomaterial aspect ratio/shape
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019
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other: unpublished study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Principles of method if other than guideline:
Method selection according to Gaillard et al., Nanoscale Adv., 2019, 1, 781
GLP compliance:
no
Type of method:
transmission electron microscopy
Details on methods and data evaluation:
TEM image evaluation according to Verleysen et al., Materials 2019, 12, 2274; doi:10.3390/ma12142274
Sample Preparation: Dispersion in ethanol; transfer to carbon-coated TEM-grids.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform

Data gathering

Instruments:
Philips CM120 120kV

Results and discussion

Shape description
Key result
Shape:
spherical
Remarks on result:
other: The material is assigned to the “spheroidal” shape category.
Aspect ratio
Key result
x Dimension:
1.3
St. dev.:
0.3
y Dimension:
1
Remarks on result:
other: median (D50)

Any other information on results incl. tables

The number-based concentration of particles with sizes below 100 nm (smallest feret diameter) is 83%. The median (D50) of the particle size is 64,9 nm.

The material is therefore classified as “nano” according to the definition of nanomaterial.

Applicant's summary and conclusion

Conclusions:
The particles have a median aspect ratio of 1,3:1.
The shape is “spherical”.
The material is assigned to the “spheroidal” shape category.