Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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)