Registration Dossier

Administrative data

Endpoint:
other distribution data
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: See 'Remarks'
Remarks:
The reference contained in this short entry represents investigations on the transport behaviour of titanium dioxide nanoparticles in the environment, with very limited value for risk assessment purposes. The reference do not fulfil the criteria for quality, reliability and adequacy of experimental data for the fulfilment of data requirements under REACH and hazard assessment purposes (ECHA guidance R4 in conjunction with regulation (EC) 1907/2006, Annexes VII-X). The information contained therein were included for information purposes only.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The transport of radioactive-labeled titanium dioxide nanoparticles ([48V]TiO2 NP) through columns filled with either sand (125-200 µm) or sediment (63-250 µm) was investigated by radioactivity measurement in the eluate. A solution of fulvic acid in distilled water (5 mg/L) with a flow rate of 1 ml/min was used as eluant.
GLP compliance:
not specified
Remarks:
not specified in study report
Type of study:
other: column transport
Media:
other: sand or sediment

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform
Details on test material:
- Name of test material (as cited in study report): radioactive-labeled titanium dioxide (Aeroxide P25, Evonik Industries (Degussa); anatase/rutile 80/20); TiO2 nanoparticles were activated by proton radiation to generate vanadium nuclides [48V], which decay to [48Ti] under emission of radioactive radiation.
- Particle size: 28 nm
- Purity: 96 %

Results and discussion

Any other information on results incl. tables

A retention of 8 % and 18 % in sand and sediment, respectively, of [48V]TiO2 nanoparticles was observed. However,the study has several methodological shortcomings so that reported effects cannot be considered reliable for the risk assessment: Tests were conducted without addition of ions, although ionic strength significantly influences transport of TiO2 NP; all tests were conducted in the presence of fulvic acid; TiO2 suspension was pumped through the column instead of being applied to the surface of the test column and irrigated with artificial rain as specified in OECD 312 ("Leaching in soil columns"); the number of replicates is not reported.

Applicant's summary and conclusion

Conclusions:
The study has methodological shortcomings so that reported effects cannot be considered reliable.