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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Method shortly described ; no analytical purity reported; only 4 strains tested
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Maleic acid dimethylester: evaluation of dermal toxicity and genotoxicity
Author:
Heimann KG, Jung R, and Kieczka H
Year:
1991
Bibliographic source:
Fd. Chem. Toxic. 29, 575-578
Reference Type:
publication
Title:
Maleinsäuredimethlyester-Prüfung auf Mutagenität im Ames Test Laboratorium für Mutagenitätsprüfungen, Maleic acid dimethylester: evaluation of dermal toxicity and genotoxicity
Author:
Miltenburger HG
Year:
1982
Bibliographic source:
Technische Hochschule Darmstadt, Report No. 023a on behalf of the BG Chemie.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Method described in short; no analytical purity reported; only 4 strains tested.
Principles of method if other than guideline:
This test was carried out according to Ames et al. 1977.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl maleate
EC Number:
210-848-5
EC Name:
Dimethyl maleate
Cas Number:
624-48-6
Molecular formula:
C6H8O4
IUPAC Name:
dimethyl (Z)-but-2-enedioate
Details on test material:
- Name of test material (as cited in study report): maleic acid dimethylester
- Analytical purity: no data

Method

Target gene:
His operon
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538.
Remarks:
Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, 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, and 5000 µg/plate.
Vehicle / solvent:
no data
Details on test system and experimental conditions:
no data
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
A preliminary screening test had shown that the concentration of 5000 µg/plate was slightly cytotoxic.
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538

Any other information on results incl. tables

None of tested concentrations of dimethyl maleate caused an elevated number of revertants in any of the tested strains, with or without a metabolizing system.. Therefore, it can be stated that maleic acid dimethylester caused did not induce point mutation in bacteria.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative