Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In an OECD Guideline 429 study (Skin Sensitisation: Local Lymph Node Assay), groups of four female CBA/J Rj mice were treated with: 100, 50 and 25% (w/v) Tellurium powder. Under the conditions of the present assay Tellurium powder tested in Propylene Glycol as vehicle, was shown to have a sensitization potential (sensitizer) in the Local Lymph Node Assay.

However, the dose response was not clear, no high SI values were seen and metals are known to have a lower predictivity in the LLNA than organic molecules.


Migrated from Short description of key information:
Reliable data from a LLNA assay with Tellurium are available.

Justification for selection of skin sensitisation endpoint:
Data from the key study are GLP-compliant and of high quality (Klimisch 1).

Justification for classification or non-classification

Skin sensitisation:

In an OECD Guideline 429 study (Skin Sensitisation: Local Lymph Node Assay), stimulation index values of the test item were 3.2, 3.2 and 3.8 at treatment concentrations of 100, 50 and 25% (w/v), respectively.

According to the CLP Regulation (EU GHS Regulation (EC) No 1272/2008) classification and labelling is required for skin sensitisation of tellurium, with category 1B and H317