Registration Dossier

Diss Factsheets

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:

Read across to fumaric acid is considered valid and malic acid is concluded to have low toxicity.

The rational for read across is that fumaric acid will metabolise in biological systems to malic acid. Fumaric acid is also slightly more fat soluble and is considered more likely to absorb to membranes and increase transport.

It is not considered valid to perform further animal tests on malic acid.

Migrated from Short description of key information:
Negative, based on read across

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data available, but not considered to be sensitising based on absence of effects in LLNA

Justification for classification or non-classification