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:

The contact hypersensitivity potential of Silica-Zirkonia Filler was tested in a Local Lymph Node Assay according to OECD Guideline 429. Groups of five female CBA/J mice were treated with test substance concentrations of 0, 10, 25 or 50% w/w suspended in propylene glycol. The solid test substance was not soluble in this vehicle. No skin irritation was observed. Measurement of radioactivity resulted in Stimulation Indices of 1.6, 1.4 and 1.3 for the three different test substance concentrations.

Migrated from Short description of key information:

No sensitising potential was observed in a local lymph node assay.

Justification for classification or non-classification

No classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC), respectively.