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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Additional information

Theres is clear evidence to indicate that dibutyl maleate is not mutagenic in in vitro bacterial test system (RL1), with or without metabolic activation.

An in vitro cytogenicity assay (RL1) has been performed with dibutyl maleate in Chinese hamster ovary cells with or without metabolic activation. Results indicated that dibutyl maleate induces chromosomal aberrations and inhibits cell cycle progression and chromosome segregation. Another study using mouse lymphoma cells L5178Y TK+/- (RL1), dibutyl maleate was found to be non mutagenic with or without metabolic activation up to 156 ug/ml.

In addition, two mammalian in vivo micronucleous assay (RL1; RL2) have been conducted. Dibutyl maleate did not induce micronucleous formation in mouse bone marrow.

Based on these results, dibutyl maleate is not genotoxic. The relevance of positive findings in the chromosomal aberration remains unclear.


Short description of key information:
Several bacterial or mammalian gene mutation assays have been conducted. In addition, an in vitro chromosomal aberration assay, in vitro mouse lymphoma assay, or in vivo micronucleus assay have been conducted with dibutyl maleate.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to criteria in Regulation (EC) No.1272/2008 the substance does not have to be classified for genotoxocity.