Registration Dossier

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