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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Before GLP implementation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
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): P5110
- 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: clear 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: stable
- Storage condition of test material: at room temperature
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Batin and Kingman Ltd., Grimston, Aldbrough, Nr. Hull
- Age at study initiation:
- Weight at study initiation: 142 -167 g
- Fasting period before study: overnight (18-20 hrs)
- Housing: Groups of 2 (dose-range finding study); Groups of 5 (main study) by sex and dose group in solid bottomed plastic cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -25
- Humidity (%): 40-60
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
Dose range finding test: 5, 25, 125, 500 mg/ml
Main study: 200, 283, 400, 566 mg/ml
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED: 5660 mg/kg
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- Dose range-finding study
50 mg/kg
250 mg/kg
1250 mg/kg
5000 mg/kg
Main study
2000 mg/kg
2830 mg/kg
4000 mg/kg
5660 mg/kg - No. of animals per sex per dose:
- Dose range-finding study
50 mg/kg 2 male/2 female
250 mg/kg 2 male/2 female
1250 mg/kg 2 male/2 female
5000 mg/kg 2 male/2 female
Main study
2000 mg/kg 5 male/5 female
2830 mg/kg 5 male/5 female
4000 mg/kg 5 male/5 female
5660 mg/kg 5 male/5 female - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 15 min, 1, 2 and 4 hours after the treatment and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Probit analisys (Finney D.J. (1964), Statistical Method for Biological Assay, 2nd Edition, London Charles Griffin).
Results and discussion
- Preliminary study:
- Dose-range finding study
The mortalities indicated an LD50 in the range 1250- 5000 mg/kg.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 770 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 4 216 - < 5 397
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 476 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3 688 - < 5 431
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 499 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 4 430 - 6 826
- Mortality:
- Eight animals (4 male, 4 female) treated with 5660 mg/kg and 2 males treated with 4000 mg/kg died during the study. All deaths were recorded between 15 minutes and 24 hours of dosing. No deaths were recorded in animals treated with 2000 and 2830 mg/kg.
- Clinical signs:
- All sings of toxicity noted in animals treated with 5660 mg/kg occurred during the day of dosing.
Sings commonly recorded in this group were lethargy or prostration, piloerection, hunched posture and slow shallow or laboured respiration.
The 2 surviving animals appeared normal 24 hours after treatment and througout the remainder of the observation period.
Lethargy was also noted in 4 animals treated with 4000 mg/kg between 15 minutes and 1 hour after treatment. Other sings of toxicity recorded during the day of dosing were piloerection and laboured respiration. All surviving animals appeared normal 2 hours after treatment and throughout the observation period.
One female treated with 2830 mg/kg appeared lethargic with piloerection 1 hour after dosing. This animal recovered and no further signs of toxicity were noted during the observation period.
All animals treated with 2000 mg/kg appered normal throughout the observation period. - Body weight:
- All surviving animals showed normal body weight gain throughout the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results acute oral toxic classification is not needed.
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