Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a guinea pig maximisation test, MDA showed a weak sensitizing potential (Thorgeirsson, 1978). However, patch tests in volunteers revealed a skin sensitizing potential of MDA in man (Morris et al, 1954)

Migrated from Short description of key information:
Animal data on skin sensitization do not result in conclusive evidence on the skin sensitization potential of MDA. However, based on the data on humans there is convincing evidence that MDA is a skin sensitizer. MDA also demonstrates cross-reactions to para-groups. Based on human data MDA is already classified as "sensitising" and labelled with R43 (may cause sensitisation by skin contact). (From the EU Risk assessment on MDA published 2001)

Justification for classification or non-classification

According to regulation 1272/2008/EC, MDA is classified as skin sensitising, H317: may cause allergic skin reaction.

MDA is classified according to annex I, directive 67/548/EC: R43 -May cause sensitisation by skin contact.