Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: No bioaccumulation potential.
Toxicokinetics: Rapid absorption following oral dosing. Extensively metabolised and eliminated principally via the lungs as exhaled carbon dioxide.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Both the L-and DL-isomers of malic acid are rapidly absorbed following oral administration. Tissue distribution has not been studied. However, malic acid occurs naturally and is a key part of metabolic processes being part of the Krebbs cycle. As a result it is expected to be extensively distributed throughout the body. Metabolism and elimination is rapid, the majority eliminated as exhaled carbon dioxide within 24 hours with minor amounts eliminated via urine and faeces in the same period.

It is noted that fumaric acid will metabolise through malic acid in biological systems as part of the Krebbs cycle and, as a result, the toxicological properties of fumaric acid are considered to be similar to those of malic acid and thus data on fumaric acid is regarded as being of use in assessing the properties of malic acid.

Discussion on bioaccumulation potential result: In view of the rapid metabolism of malic acid, and its natural presence in the metabolic cycle, there is little or no potential for bioaccumulation.