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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Dose descriptor:
LOAEL
30 mg/kg bw/day
Additional information

In a combined repeated dose and reproductive/developmental toxicity screening test, an increased absolute and/or relative liver and kidney weights in female and male rats and renal tubular lesions in male rats were observed in high dose animals (300 mg/kg). No adverse effect on reproductive performance was found. The NOEL was determined to be 95 mg/kgBW/day. The kidney and liver were identified as the main target organs. A a 90 -day oral subchronic toxicity was conducted and is presented in the repated dose section. Dibutyl maleate was adminestered via oral gavage to rats at 30, 95 and 300 mg/kgBW/day. Based on chronic progressive nephropathy and mineralization in the kidneys, the LOAEL was determined to be 30 mg/kgBW/day. No adverse effects were seem in the histopathological examination of reproductive organs.


Short description of key information:
A combined repeated-dose and reproductive/developmental toxicity screening test in rat was performed according to OECD 422 guidelines with dibutyl maleate. In this study, the NOAEL for reproductive and developmental toxicity was 95 mg/kg bw/day. Also, results from a 90-day subchronic toxicity with dibutyl maleate did not show adverse effects in the reproductive organs. Based on the lack of adverse on reproductive performance, it can be concluded that dibutyl maleate is neither a developmental nor reproductive toxicant. However, as a result of the read across approach, the LOAEL of 30 mg/kg bw/day was selected for the chemical safety assessment.

Justification for classification or non-classification

According to criteria in Regulation (EC) No. 1272/2008, dibutyl maleate does not have to be classified for reproductive effects.

Additional information