Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity in vitro

Description of key information
A negative Ames test and a negative micronucleus test are available. The results demonstrate that the test substance did neither produce point mutations nor chromosome aberrations.
Link to relevant study records
in vitro gene mutation study in bacteria
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 August 1982 to 12 November 1982
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, publication/study report which meets basic scientific principles, but details missing
equivalent or similar to guideline
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
not specified
GLP compliance:
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix prepared from Aroclor-induced rat livers
Test concentrations with justification for top dose:
0, 10, 50, 250, 1250, 5000 µg/plate
Vehicle / solvent:
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Species / strain:
other: all strains
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
slighty cytotoxic at 5000 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Migrated from field 'Test system'.
The test substance did not induce point mutations in bacteria.
Executive summary:

A bacterial reverse mutation test (Ames test) was carried out with the Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 without and with a metabolic activation system (S-9 mix prepared from Aroclor-induced rat livers). Test substance concentrations were 0, 10, 50, 250, 1250 and 5000 µg/plate. Slight cytotoxicity was noted in the preliminary screening test at 5000 µg/plate.

No mutagenicity was noted at any of the tested concentration, regardless whether an external metabolising system was used or not.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

No indications were obtained that would justify a classification of dimethyl maleate.

Justification for selection of genetic toxicity endpoint
This study as well as the other study of Miltenburger 1982 on the micronucleus test should be selected for the 2 genotoxicity endpoints.

Justification for classification or non-classification