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:

No experimental data were located for Kaolin, calcined regarding skin sensitisation but there is an local lymph node assay available performed with the structurally related compound silicic acid, aluminium salt (Vogel and Reichenbach, 2010, RL2).

The skin sensitising potential of silicic acid, aluminium salt was tested in CBA/CaOlaHsd mice according to OECD Guideline 429. After the application of up to 25% w/v silicic acid, aluminium salt in DMSO, the highest technically achievable concentration, all Stimulation Indices were below 3. All treated mice survived the scheduled study period and no signs of toxicity were observed. The test item was not a skin sensitiser under the described conditions.

Migrated from Short description of key information:
skin: not sensitising (RA silicic acid, aluminium salt; LLNA, mice)

Respiratory sensitisation

Endpoint conclusion
Additional information:

There is no data for respiratory sensitisation of Kaolin, calcined available.

Justification for classification or non-classification

Based on the results obtained, Kaolin, calcined does not fulfill the criteria to be classified for skin sensitization according to DSD (67/548/EEC) or CLP (1272/2008/EC).