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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl malonate
EC Number:
203-305-9
EC Name:
Diethyl malonate
Cas Number:
105-53-3
Molecular formula:
C7H12O4
IUPAC Name:
diethyl malonate

Method

Species / strain
Species / strain / cell type:
other: TA98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Concentrations tested: 8, 40, 200, 1000, 5000 μg/plate
5000 μg/plate (maximal concentration)
Vehicle / solvent:
DMSO
Details on test system and experimental conditions:
- Species/cell type: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Metabolic activation system: phenobarbiturate induced rat liver S9 fraction
- Solvent: DMSO
- Number of replicates: 2 main studies, one plate incorporation, one pre-incubation test. Three replicates per experiment.
- Concentrations tested: 8, 40, 200, 1000, 5000 μg/plate
- Positive and negative controls:
- Negative control: solvent DMSO
- Positive control:
without S9 mix:
- TA 98, 1538: Nitrofluorene (111-304 μg/plate)
- TA 100, 1535 Sodium azide (295-372 μg/plate)
- TA 1537: Aminocridine (78-194 μg/plate)
With S9 mix:
Cyclophosphamide (93-114 μg/plate)
- Pre-incubation time: 30 min at 37 °C
STATISTICAL METHODS: Mean values and standard deviations by Biosys software.

Results and discussion

Test results
Key result
Species / strain:
other: Salmonella typhimurium TA98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Remarks on result:
other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:
No cytotoxicity was observed up to the maximum test. Thus the test substance does not fulfil the criteria for a classification as genetic toxic according to the study.