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:

Speciation:

Upon dissolution, vanadium substances transform inartificial body fluids, including PBS, sweat, gastric juice and lung fluid, predominantlyto the pentavalent form,exceptin artificial lysosomal fluid; here, even pentavalent forms are converted almost completely totetravalent 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.

Read across concept:

The toxicity of vanadium carbide may reasonably be considered to be determined by the bioavailability of vanadium. As a first surrogate for bioavailability, the water solubility of a test substance may be used. Vanadium carbide is poorly soluble in water (2.1 mg/L at 20°C/pH 5.2) whereas vanadium oxide sulphate, sodium metavanadate and divanadium pentoxide are very (>10 g/L) to moderate soluble (<1g/L) (467 g/L at 20°C/pH 1.1, 225 g/L at 20°C/pH 9.5 and 920 mg/L at 20°C/pH 2.7, respectively). Read-across from soluble to poorly soluble vanadium compounds is considered acceptable because kinetic data on the poorly soluble vanadium carbide indicate a markedly lesser solubility potential and hence bioavailability than that of soluble vanadium substances. However, it is to be concluded that this read-across will likely result in rather conservative no-effect levels.

Thus, read-across of data between vanadium carbide and vanadium oxide sulphate, sodium metavanadate and divanadium pentoxide

is considered to be fully justified.

Migrated from Short description of key information:
Soluble tri-, tetra- and pentavalent vanadium substances did test negative (i.e. not sensitising) in 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 carbide is not considered to have a sensitisation potential.

Justification for selection of skin sensitisation endpoint:
The studies by Haferkorn (2010a,b,c) are considered key studies on skin sensitisation and are used for classification. Soluble tri-, tetra- and pentavalent vanadium substances failed to elicit any skin sensitising response in sensitisation studies according to Magnusson and Kligman (OECD 406). Positive human experience with any vanadium substance has not been reported.

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 functions have not been diagnosed in vanadium and vanadium carbide producing facilities.

Justification for classification or non-classification

Based on the outcome of sensitisation studies with soluble vanadium forms according to Magnusson and Kligman, it can be concluded that vanadium carbide does not have a sensitisation potential and therefore must not be classified and labelled according to Directive 67/548/EEC and Regulation (EC) 1272/2008.