Registration Dossier

Diss Factsheets

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:

The key study was a skin sensitisation study conducted in accordance with OECD guideline 406 using a Magnusson and Kligman test (Török-Bathó, 2013). Tantalum pentoxide was tested negative for skin sensitisation in this study.

In a second sensitisation study tantalum pentoxide was tested for sensitizing properties in accordance with OECD guideline 429 using the mouse Local Lymph Node Assay (Hargitai, 2013). In this study a stimulation index greater than 3 was obtained at the mid-concentration of 25 % but not at 50 % or 10 %. As no dose response occurred tantalum pentoxide can be considered as potentially not sensitizing, but the result from this study need to be verified.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with criteria for classification for skin sensitisation of Regulation (EC) No. 1272/2008 and Directive 67/548/EEC , the test material did not elicit a response in the Maximisation assay and therefore does not meet the criteria for classification as a skin sensitiser.