Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-305-9 | CAS number: 105-53-3
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
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
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
