Registration Dossier

Diss Factsheets

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other: unpublished report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Principles of method if other than guideline:
Image analysis: manual image analysis according to REACH criteria (NanoDefine ParticleSizer)
Guidelines from NanoDefine are applied:
Method selection according to Gaillard et al., Nanoscale Adv., 2019, 1, 781
TEM image evaluation according to Verleysen et al., Materials 2019, 12, 2274; doi:10.3390/ma121
GLP compliance:
no
Type of method:
transmission electron microscopy
Details on methods and data evaluation:
Sample Preparation:
Dispersion in ethanol; transfer to carbon-coated TEM-grids.

Test material

Constituent 1
Chemical structure
Reference substance name:
Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
EC Number:
231-494-8
EC Name:
Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
Cas Number:
7585-41-3
Molecular formula:
C18H13ClN2O6S.Ba
IUPAC Name:
barium 4-[(5-chloro-4-methyl-2-sulfonatophenyl)diazenyl]-3-hydroxy-2-naphthoate
Test material form:
solid: nanoform
Details on test material:
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Data gathering

Instruments:
Thermo-Fisher Talos 200kV
Calibration:
every 12 months with Mag*i*Cal sample
Reproducibility:
systematic error +/-3%

Results and discussion

Shape description
Key result
Shape:
rod
Remarks on result:
other: The material is assigned to the “elongated” shape category.
Aspect ratio
Key result
x Dimension:
3.5
St. dev.:
2.1
y Dimension:
1
Remarks on result:
other: median (D50)

Applicant's summary and conclusion

Conclusions:
- The particles have a median aspect ratio of 3,5:1.
- The shape is rod. The material is assigned to the “elongated” shape category.
- The median (D50) of the particle size is 23,9 nm. The test substance is therefore classified as “nano” according to the definition of nanomaterial 2011/696/EU.