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:

A guinea pig maximization study, according to Magnusson & Kligman, was conducted to determine the potential of DPGDB for skin sensitization to guinea pigs. The study was conducted according to EPA, OECD and EC test guidelines, and in compliance with GLP. Evidence of skin sensitization was seen in all animals treated by the positive control substance, Hexyl cinnamic aldehyde, confirming the sensitivity of the method. Guinea pigs were treated with stock DPGDB for the intradermal injection (as 50:50 in FCA) and topical induction phases, and stock and 50% in Alembicol D for the topical challenge phase. At the end of the challenge phase, no positive reactions were observed in the test article-treated animals.

Justification for classification or non-classification

According to the criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) DEGDB is not considered a skin sensitizer.