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:

In a key dermal sensitisation study using paraffin wax, Dunkin Hartley albino guinea pigs (10/sex) were tested using the Magnusson & Kligman Guinea Pig Maximisation Test along with appropriate positive and negative controls. At the topical challenge phase, no skin reactions were observed at 24 or 48 hours in both the controls and groups treated with 10% or 50% paraffin wax in propylene glycol. There was a 0% sensitisation rate. Therefore, under conditions ofthis study, paraffin wax is not a dermal sensitiser.

Migrated from Short description of key information:

In a key dermal sensitisation study in guinea pigs (OECD 406), 100% paraffin wax was not found to be sensitising to the skin.  

Respiratory sensitisation

Endpoint conclusion
Additional information:

Migrated from Short description of key information:

No data reported

Justification for classification or non-classification

Paraffin and hydrocarbon waxes do not meet the EU criteria for skin sensitisation and are therefore not classified.