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 substances, elicited negative response after topical application to the mouse ear in LLNA. No clinical signs of systemic intoxication were detected in study of sensitization. The substance showed a tendency to increase ear weight - dose dependent, not statistically significant. Therefore the skin irritation effect was not considered as positive, but this finding showed evidence of certain irritant potential.   


Migrated from Short description of key information:
Fluidized Bed Combustion (FBC) Fly Ash and Fluidized Bed Combustion (FBC) Bottom Ash were tested for the assessment of skin sensitisation potencial with murine local lymph node assay. The Local Lymph Node Assay (LLNA) with radionuclides was used.

The both tests were performed in accordance with GLP principles.

Justification for classification or non-classification

Based on the negative results of LLNA study of the test substances Fluidized Bed Combustion (FBC) Bottom Ash and Fluidized Bed Combustion (FBC) Fly Ash, it could be suggested, that the test substances, do not have to be classified as the substance, which may cause sensitisation by skin contact.