Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 217-385-8 | CAS number: 1830-54-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dimethyl 3-oxoglutarate
- EC Number:
- 217-385-8
- EC Name:
- Dimethyl 3-oxoglutarate
- Cas Number:
- 1830-54-2
- Molecular formula:
- C7H10O5
- IUPAC Name:
- dimethyl 3-oxoglutarate
- Details on test material:
- - Name of test material (as cited in study report): LZ409, Batch No. 46332
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance):
- Substance type: organic
- Physical state: yellow liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:
Constituent 1
Method
- Target gene:
- Histidine
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:
- Aroclor induced / rat liver S9
- Test concentrations with justification for top dose:
- Toxicity study
17, 50, 167, 500, 1667 and 5000 microgram/plate
Mutation tests
17, 50, 167, 500, 1667 and 5000 microgram/plate
Quality control
- DMSO vehicle was tested at 0.1 ml/plate in both the presence and absence of S9 mix
- With S9 mix:
2-Aminoanthracene (2-AAN) was tested at 20 mikrogram/plate with E. Coli,
2 mikrogram/plate with TA 1535 and TA 1537 and
0.5 microgram/plate with TA 98 and TA 100.
- Without S9 mix:
N-Ethyl-N-nitro-N-nitrosoguanidine (ENNG) wastested at 2 mikrogram/plate with E. Coli.
Sodium azide was tested at 1 mikrogram/plate with TA 1535 and TA 100
2-nitrofluorene (2-NF) was tested at 1 mikrogramplate with TA 98
9-Aminoacridine (9-AA) was tested at 80 mikrogram/plate with TA 1537. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle:
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- sterile, ultra pure water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-ANN)
- Untreated negative controls:
- yes
- Remarks:
- sterile, ultra pure water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: NaN3
- Untreated negative controls:
- yes
- Remarks:
- sterile, ultra pure water
- Negative solvent / vehicle controls:
- no
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: 9-AA
- Untreated negative controls:
- yes
- Remarks:
- sterile, ultra pure water
- Negative solvent / vehicle controls:
- no
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: 2-NF
- Untreated negative controls:
- yes
- Remarks:
- sterile, ultra pure water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Migrated to IUCLID6: ENNG
- Details on test system and experimental conditions:
- Direct Plate Method
Volumes of soft agar (2 ml) were dispensed into small sterile tubes. To this, 0.5 ml of S9 mix or 0.05 M phosphate buffer, pH: 7.4 were added, followed by 0. 1ml of bacteria. The solvent of the test solution (0.1 ml) was added last.
The tube contents which were continually cooling, were mixed and poured onto minimal medium plates, prepared in-house. These plates contained 25 ml of 1.5 % purified agar in Vogel-Bonner medium E with 2 % glucose. When the soft agar had set, the plates were inverted and incubated at 37 C for 2 or 3 days.
The Pre-Incubation method
Volumes of S9 mix or 0.05 M phosphate buffer, pH 7.4 (0.5 ml) were dispensed into small sterile tubes. This was followed by 0.1 ml of bacetria per tube and, finally the solvent or test solution (0.1 ml per tube). The tube tops were then screwed on tightly and the tubes placed in a shaking incubator at 37 C for 20 min. After this the tube tops were removed and 2 ml of soft agar added to each tube. The tube contents which were continually cooling, were mixed and then poured onto agar plates, as above. Than the soft agar had set, the plates were inverted and incubated at 37 C for 2 or 3 days.
After incubation, the colonies were counted using a Cardinal Colony counter (Perceptive Instruments, UK) set at maximum sensitivity, i.e. colonies of 0.1 mm or more in diameter were counted. The plates were also examined for precipitates and microscopically for microcolony growth. - Evaluation criteria:
- Well established, according to Guideline.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- 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:
- Toxicity to the bacteria was observed as a thinning of the background lawn of microcolonies in the second mutation assay only (pre-incubation method).
Toxicity was observed with all 5 strains at 5000 mikrogramm/per plate, in the presence of S9 mix only.
Precipitation of the test item was observed only in the second mutation assay at 5000 mikrogramm/plate in the presence of S9 mix.
All tests were acceptable according to the study criteria. - 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
The substance did not induce mutagenic activity in any of the 5 bacterial strains used, in either activation condition.
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.