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:

TBHP caused skin sensitisation reactions in Guinea pigs. The induction and challenge regime employed corresponded to TBHP treatment at 0.7% and 2.1% (induction) and 21% (challenge). It is therefore concluded that TBHP caused delayed contact sensitisation in Guinea pigs and must be considered to be a skin sensitiser.

Migrated from Short description of key information:
A key study has been identified as having assessed the skin sensitising potential of TBHP in the guinea via the maximisation method. This study has been conducted in accordance with OECD/EU guidelines and was performed under GLP.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No evaluation of respiratory sensitisation has been performed.

Justification for classification or non-classification

Based on the results of the key study (Guinea pig maximisation test for skin sensitisation), TBHP is classified as:

- Skin Sensitisation Category 1 (may cause an allergic skin reaction) under Regulation 1272/2008 (EU CLP)