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:

Dioctyl maleate was positive in two Guinea Pig Magnusson-Kligman maximization tests, and negative in a Buhler test. An unreliable human case report (with one human) and a patch test were positive for skin sensitization reactions with up to 10% dioctyl maleate. Patch testing was conducted with individual ingredients of the moisturizing lotion containing 2, 5, and 10% dioctyl maleate. However, test conducted with 100% undiluted dioctyl maleate resulted in about 15% positive skin reaction in comparison to the control areas of all animals which were normal, therefore, we could not conclude that dioctyl maleate is a well defined skin sensitizer.

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, dioctyl maleate is non classifiable as skin sensitizer.