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EC number: 209-264-3 | CAS number: 563-80-4
- 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:
- single dose followed by 14-day observation period
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to acceptable scientific standards and reviewed by Quality Assurance. Conduct of study according to all aspects of GLP was not confirmed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Deviations:
- no
- Principles of method if other than guideline:
- Three groups of five rats per sex were administered single doses of 1250, 2500, or 5000 mg/kg bw of the test substance by oral gavage and observed for a period of two weeks. Clinical observations and mortality were noted during the study. Body weights were recorded on a weekly basis. Gross pathology was performed following death of animals and on all survivors at study termination.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3-methyl-2-butanone
- IUPAC Name:
- 3-methyl-2-butanone
- Reference substance name:
- 3-methylbutanone
- EC Number:
- 209-264-3
- EC Name:
- 3-methylbutanone
- Cas Number:
- 563-80-4
- Molecular formula:
- C5H10O
- IUPAC Name:
- 3-methylbutan-2-one
- Reference substance name:
- methylbutanone; methyl isopropyl ketone; MIPK
- IUPAC Name:
- methylbutanone; methyl isopropyl ketone; MIPK
- Details on test material:
- -Test substance: Methyl isopropyl ketone
-Date of manufacture: October 1987
-Source: Tennessee Eastman Company
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals:
-Strain: Crl:CD®(SD)BR
-Sex: Male and Female (5 of each sex/group)
-Body weight (at study initiation): Males (125-140 g), Females (130-148 g)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Each animal received a single dose of the test material by oral gavage.
- Doses:
- 1250, 2500, 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats/sex/group
- Control animals:
- no
- Details on study design:
- Three groups of five rats per sex were administered single doses of 1250, 2500, or 5000 mg/kg bw of the test substance by oral gavage and observed for a period of two weeks. Clinical observations and mortality were noted during the study. Body weights were recorded on a weekly basis. Gross pathology was performed at study termination or upon death of study animals. The dose levels were selected based on the results of two range finding studies in which doses of up to 2500 mg/kg bw did not cause mortality. Selected gross lesions were processed for microscopic evaluation.
- Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 078 mg/kg bw
- 95% CL:
- 2 333 - 4 061
- Mortality:
- One male and one female died in the 2500 mg/kg bw group by 24 hours post-dose. All animals in the 5000 mg/kg bw group died between 1.7 hours to 1 day post-dose. All remaining animals survived the 14-day observation period.
- Clinical signs:
- other: Abnormal clinical signs in all dose groups were observed only on the day animals were dosed. Abnormal clinical signs at the 5000 mg/kg bw dose level included ataxia and slight weakness in all animals immediately after dosing. One hour after administratio
- Gross pathology:
- Test substance-related changes observed at necropsy of the 5000 mg/kg bw animals which died after dosing were limited to test substance in the gastrointestinal tract (2/5 males, 3/5 females). No treatment-related changes were observed at necropsy of animals administered a dose of 2500 or 1250 mg/kg bw. All other gross lesions were considered not treatment-related.
- Other findings:
- Selected gross lesions were processed for microscopic evaluation. These lesions either could not be confirmed microscopically, or were identified as autolytic changes. The cause of death for animals which died after exposure to the test substance was not determined.
Any other information on results incl. tables
Two range finding studies were conducted using one animal of each sex per dose level. Dose selections of 78, 156, 312, 625, and 1250 mg/kg bw were administered as a 25% solution in corn oil. In the second study, the test substance was administered neat at dose levels of 156, 312, 625, 1250, and 2500 mg/kg bw. All animals in both studies survived the 14-day observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Classified Category V per UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS); however, there is no Category V in CLP Regulation (EC) No. 1272/2008; classified Category 3 for Specific Target Organ Toxicity – Single Exposure
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under conditions used in this study, the single dose oral LD50 in male and female rats was calculated to be 3078 mg/kg bw (95% CL 2333-4061). Clinical signs indicating reversible effects on the central nervous system included slight to moderate weakness and ataxia.
Based on an acute oral LD50 value of 3078 mg/kg bw in rats, methyl isopropyl ketone is classified as Category V for classification and labeling for acute lethality by the oral route under the UN GHS regulations; however, there is no Category V in EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Therefore, methyl isopropyl ketone is not classified for acute lethality according to EU CLP GHS in this study. Based on clinical signs indicating reversible effects on the central nervous system, methyl isopropyl ketone is classified as Category 3 for classification and labeling under GHS for Specific Target Organ Toxicity – Single Exposure. This acute oral classification is supported by similar clinical signs and an oral LD50 of 3200 mg/kg bw in an earlier supporting study conducted in rats and mice by the same test laboratory. - Executive summary:
In an acute oral toxicity study, three groups containing five rats/sex/group were administered a single dose of methyl isopropyl ketone by oral gavage at dose levels of 1250, 2500, or 5000 mg/kg bw. The rats were observed for mortality and adverse clinical signs for a period of 14 days. All rats in the 5000 mg/kg bw dose group and one rat per sex in the 2500 mg/kg bw dose group died by 24 hours after test substance administration. No other mortality was noted during the study. The calculated oral LD50 in rats administered methyl isopropyl ketone was 3078 mg/kg bw. Clinical signs of toxicity reported in the study summary included weakness (moderate to slight), ataxia, and prostration. No other clinical abnormalities were noted throughout the study. All surviving rats gained weight over the 14-day observation period. Based on the results of this study, methyl isopropyl ketone may be harmful by the oral route. Ingestion of large amounts may cause transient CNS depression.
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