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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Absorption, distribution: Systemic effects indicated an absorption of the test substance in the gastrointestinal tract. The dermal absorption is estimated to be low. Absorption after inhalation was observed.
The water solubility is rather high (78 g/L), the n-octanol/water partition coefficient is low (logPow = 0.52), the molecular mass is low (144), therefore it is anticipated also from the physico-chemical parameters that the substance is able to penetrate biological membranes to some extent.
Metabolism: No indication of the importance of the metabolism was obtained.
Excretion: No relevant data are available.
Bioaccumulation: From the low logPow no relevant bioaccumulation potential is anticipated.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The toxicokinetic behaviour of dimethyl maleate was estimated from available data for the purpose of registration of the substance.

Absorption, distribution: Systemic effects were detected in the acute and subacute oral toxicity study at high doses, indicating an absorption of the test substance in the gastrointestinal tract.

No indication for a dermal absorption was obtained from the acute dermal toxicity study. The difference between oral and dermal acute toxicity indicate a low or a slow dermal absorption. Systemic effects were observed in a subacute dermal toxicity study with rats at high doses, indicating a dermal absorption to some degree. A slight dermal absorption is also derived from the positive skin sensitisation study (GPMT). The rather high water solubility and the low n-octanol/water partition coefficient would impede a dermal absorption, whereas the low molecular mass would favour it.

The vapour pressure is medium, the saturation concentration only produced death in rats after ca. 8 h exposure.

The water solubility is rather high (78 g/L), the n-octanol/water partition coefficient is low (logPow = 0.52), the molecular mass is low (144), therefore it is anticipated also from the physico-chemical parameters that the notified substance is able to penetrate biological membranes to some extent.

Metabolism: No genotoxicity was detected in the bacterial reverse mutation assay with and without metabolizing enzymes and no indication of the importance of the metabolism of the notified substance was obtained from this study.

Excretion: No relevant data are available, which could provide evidence on the route and extent of excretion.

Bioaccumulation: No statement on the bioaccumulation can be derived from the comparison of the effective doses in the acute and the repeated dose dermal toxicity study, when also considering the different extent of the investigations in both studies. From the low logPow no relevant bioaccumulation potential is anticipated.