Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Description of key information

There is available information in humans that the substance should be classified for skin sensitisation. A skin patch test study in humans is available that reports a positive result and therefore a study is not required (Morris et al, 1954).

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

Justification on read-across of data for the 4,4´-isomer of MDA for oligomeric MDA in the scope of REACH is documented in IUCLID Toxicological information and described in sections 5.1 and 5.11 of the CSR.

A study with patch tests in volunteers revealed a skin sensitizing potential of MDA in man (Morris et al, 1954)

The following information is taken into account for any hazard / risk assessment:

There is convincing evidence that MDA is a skin sensitizer in humans. 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)

Migrated from Short description of key information:
Value used for CSA: sensitising

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.