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:

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.