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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
no adverse effect observed (not sensitising)
Additional information:

Ethylenediamine, +4PO was assessed for its sensitising effect on the skin using a Guinea Pig Maximisation Test (GPMT) in a GLP and OECD guideline 406 study (BASF SE 30H0530/882207, 1989).

During a range finding test, the minimum irritant concentration was found to be a 50 % and the maximum non-irritant concentration a 25 % aqueous test substance preparation . 5 % ethylenediamine, +4PO was applied for intradermal induction followed by epicutaneous induction using a 50 % test substance preparation. For challenge and rechallenge, animals were exposed to 25 % ethylenediamine, +4PO. However, challenge and rechallenge only led to a slight, transient erythema in a single case. According to the present study, Ethylenediamine, +4PO can thus be considered as not sensitising to the skin.

Migrated from Short description of key information:

Skin sensitization (OECD 406 & GLP): not sensitising (BASF SE 30H0530/882207; 1989) (GPMT: intradermal induction: 5 %; epicutaneous induction: 50 %; 1. challenge: 25 %; 2. challenge: 25 %)

Justification for classification or non-classification

The available study is considered reliable and suitable for classification purposes under 67/548/EEC and 1272/2008/EEC. In conclusion, ethylenediamine, +4PO does not require classification for skin sensitisation.