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Registration Dossier
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EC number: 205-093-3 | CAS number: 133-13-1
Toxicological information
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- 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:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diethyl ethylmalonate
- EC Number:
- 205-093-3
- EC Name:
- Diethyl ethylmalonate
- Cas Number:
- 133-13-1
- Molecular formula:
- C9H16O4
- IUPAC Name:
- 1,3-diethyl 2-ethylpropanedioate
- Test material form:
- liquid
- Details on test material:
- Test item: diethyl ethylmalonateCAS No.: 133-13-1Physical state: colourless liquidStorage: in cool, dry, well-ventilated place
Constituent 1
Method
- Target gene:
- Salmonella typhimurium TA98: hisD3052; TA100: hisG46; TA1535: hisG46; TA1537: hisC3076Escherichia coli WP2 uvrA: trpE
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Based on the results of the preliminary Range Finding Test the following concentrations of the test item were prepared and used in the Initial and Confirmatory Mutation Tests: 5000, 1600, 500, 160, 50 and 16 μg/plate.
- Vehicle / solvent:
- Dimethyl sulfoxide (DMSO)Ultrapure water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO, UPW
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- other: 4-Nitro-1,2-phenylenediamine (NPD)
- Remarks:
- Dose: 4 μg/plate; vehicle: DMSO; strain: Salmonella typhimurium TA98
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- sodium azide
- Remarks:
- Dose: 2 μg/plate; Vehicle: UPW; strain: Salmonella typhimurium TA100 and TA1535
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Dose: 50 μg/plate; vehicle: DMSO; strain: Salmonella typhimurium TA1537
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Dose: 2 μL/plate; vehicle: UPW; strain: Escherichia coli WP2 uvrA
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- Dose: 2 μg/plate; vehicle: DMSO; strains: Salmonella typhimurium TA98; TA100; TA1535; TA1537
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- Dose: 50 μg/plate; vehicle: DMSO; strain: E. coli WP2 uvrA
- Details on test system and experimental conditions:
- The study included a Preliminary Solubility Test, a Preliminary Range Finding Test (Informatory Toxicity Test), an Initial Mutation Test (Plate Incorporation Test), and a Confirmatory Mutation Test (Pre-Incubation Test).In the preliminary Range Finding Test as well as in the Initial Mutation Test the plate incorporation method was used.
- Evaluation criteria:
- A test item is considered mutagenic if:- a dose–related increase in the number of revertants occurs and/or;- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.An increase is considered biologically relevant if:- in strain Salmonella typhimurium TA100 the number of reversions is at least twice as high as the reversion rate of the vehicle control;- in strain TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA the number of reversions is at least three times higher than the reversion rate of the vehicle control.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- the lowest cytotoxic concentration: 1600 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- the lowest cytotoxic concentration: 1600 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Signs of cytotoxicity has been observed in all tested strains without exogenous metabolic activation. The 1600 μg/plate was found to be the lowest cytotoxic concentration, observed in the Confirmatory Mutation Test in Salmonella typhimurium TA98 and TA100, without S9 Mix.No biologically relevant increases were observed in revertant colony numbers of any of the five test strains following treatment with diethyl ethylmalonate (CAS No. 133-13-1) at any concentration level, either in the presence or absence of metabolic activation (S9 Mix) in the performed experiments.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test item diethyl ethylmalonate (CAS No. 133-13-1) has no mutagenic activity on the applied bacterium tester strains under the test conditions used in this study.
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