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, vanadium, oxalate complexes is not assumed to have a potential for skin sensitisation.

Read across

Upon dissolution, vanadium substances including tri- and tetravalent 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.

Oxalic acid is a dicarboxylic acid occurring in many plants and vegetables and as such part of the daily diet. It is produced in the body by metabolism of glyoxylic acid or ascorbic acid and is not metabolized but excreted in the urine. Because of the intrinsic nature of oxalate as endogenous physiological compound, any skin sensitising effect of oxalate 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.


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. Vanadium, oxalate complexes 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, oxalate complexes does not have a sensitisation potential and therefore must not be classified and labelled according to Directive 67/548/EECand Regulation (EC) 1272/2008.