Dimethyl malonate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Adopted according to OECD SIDS (publicly available peer reviewed source). Original document not available.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1992

Reference 2

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report For SIAM 20 (Malonic Acid Diesters: Dimethylmalonate, 108-59-8; Diethylmalonate, 105-53-3), April 19-22, 2005 Paris.

Author:

OECD SIDS

Year:

2005

Bibliographic source:

UNEP Publications

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

yes

Remarks:

Use of 4 Salmonella typhimurium strains instead of 5 strains, as cited in the actual test requirements (OECD TG 471, adopted 1997)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl malonate

EC Number:

203-597-8

EC Name:

Dimethyl malonate

Cas Number:

108-59-8

Molecular formula:

C5H8O4

IUPAC Name:

dimethyl malonate

Details on test material:

Purity: ca. 99 %
Impurities from the production process: methanol (ca. 0.3 %) and dimethyl-methylmalonate (ca. 0.2%)
Physical state: liquid, colorless

Method

Target gene:

his operon

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbiturate-induced rat liver S9 fraction of male Wistar rats

Test concentrations with justification for top dose:

8-5000 µg/plate

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Positive control substances: Without S9: TA 98, 1538: Nitrofluorene TA 100, 1535: Sodium azide TA 1537: Aminoacridine With S9: Cyclophosphamide (TA 100 only)

Details on test system and experimental conditions:

METHOD OF APPLICATION: 2 independent assays, one plate incorporation, one pre-incubation test.

DURATION
- Preincubation period: 30 min

NUMBER OF REPLICATIONS: 3 replicates

Statistics:

Mean values and standard deviation were calculated with BIOSYS software.

Results and discussion

Test results

Test results 1

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:

>=1000 µg/plate

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>=1000 µg/plate

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation occurred

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative