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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
55 mg/kg bw/day
Additional information

No adverse effects on litter size and on pup survival were observed at doses up to 150 mg/kg/day in the F1 litters, or at 55 mg/kg/day in the F2 litters. Microscopic examination of tissues from pups in the F2 liters revealed no treatment-related changes. Therefore, treatment up to 55 mg/kg/day for two generations had no adverse effect on pups.

Since maleic anhydride will convert to maleic acid very quickly in a solution, it is assumed this result (NOAEL) is also applicable for maleic acid.


Short description of key information:
IRDC, 1982: Three Generation Reproduction Study in Rats (Modified to a Two Generation Study) with the closely related substance maleic anhydride: no adverse effects on fertility up to 55 mg/kg/day. Since maleic anhydride will convert to maleic acid very quickly in a solution, it is assumed this result (NOAEL) is also applicable for maleic acid.

Justification for classification or non-classification

Additional information