Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Soluble tri-, tetra- and pentavalent vanadium substances failed to elicit any skin sensitising response in sensitisation studies according to Magnusson and Kligman (OECD 406).The studies by Haferkorn (2010a,b,c) are considered key studies on skin sensitisation and are used for classification.Positive human experience with any vanadium substance have not been reported. Based on read-across, divanadium tris(sulphate) is not assumed to have a potential for skin sensitisation.

Read across

Upon dissolution, vanadium substances including trivalent compounds, transform in artificial body fluids, including PBS, sweat, gastric juice and lung fluid, predominantly to the pentavalent form, except in artificial lysosomal fluid; here, even pentavalent forms are converted almost completely to tetravalent species already after a short period of time (for more information on in vitro bioaccessibility testing,please refer IUCLID section 7).Thus, it can be assumed that vanadium speciation in body fluids is controlled by the conditions of the respective medium but not by the vanadium source. Thus, read-across of skin sensitisation data from soluble tri-, tetra- and pentavalent vanadium substances is justified.

Sulfate (i) is ubiquitous in the environment (air, soil and water) and as part of the natural sulfur cycle intrinsically present in the human body due to a natural background in all dietary sources, (ii) sulfate as a normal constituent of all body fluids plays an important role for the ionic balance, and (iii) Sulfate is essential for many biological processes, i.e. sulfate is needed for the synthesis of 3′-phosphoadenosine-5′-phosphosulfate (PAPS) which in turn is required for the bio synthesis of many important sulfur-containing compounds, such as chondroitin sulfate and cerebroside sulfate. Because of the intrinsic nature of sulfate as endogenous physiological compound, any skin sensitising effect of sulfate is not to be expected. In consequence, any effects observed in human health studies are based on the vanadium ion and not on the cation. Nevertheless, a study conducted with vanadium oxide sulfate is included as weight of evidence and indicates the complete lack of a sensitising potential of sulfate-containing vanadium substances.


Migrated from Short description of key information:
Soluble tri-, tetra- and pentavalent vanadium substances tested negative (i.e. not sensitising) in skin sensitisation studies according to Magnusson and Kligman (OECD 406). A justification for using the Magnusson and Kligman design instead of the LLNA is provided as attached document below. Divanadium tris(sulphate) is not considered to have a sensitisation potential.

Justification for selection of skin sensitisation endpoint:
The studies by Haferkorn (2010) are considered key studies on skin sensitisation and used for classification.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Vanadium exposure has not been reported to induce immune responses in vanadium industry workers, and occupational asthma or reduced lung function have not been diagnosed in vanadium and vanadium substances producing facilities.

Justification for classification or non-classification

Based on the outcome of the sensitisation study according to Magnusson and Kligman, it can be concluded that vanadium oxide sulphate does not have a sensitisation potential and therefore must not be classified and labelled according to Directive 67/548/EECand Regulation (EC) 1272/2008.