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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24-hour exposure followed by a 14-day observation period
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to a method similar to OECD Guideline 402 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Method is an in vivo study using 5 rats/sex. A single limit dose of 20 mL/kg bw of the test substance was held in contact with the clipped dorsum of the animals under an occlusive cuff for 24 hours. Animals were observed after exposure for mortality, dermal reactions, and weight changes for a total of 14 days. Gross pathology was performed at study termination.
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
-Specific gravity: 0.805
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 (221-247 g), Females (172-204 g)
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Following depilation of each animal's dorsum, a single dose of 20.0 mL/kg bw of the test substance was applied under an occlusive cuff and wrap. After a 24 hour exposure period, the cuffs and wrappings were removed.
- Duration of exposure:
- 24 hours
- Doses:
- 20 mL/kg bw
- No. of animals per sex per dose:
- 5 rats/sex
- Control animals:
- no
- Details on study design:
- Method is an in vivo study using 5 rats/sex. A single dose of 20 mL/kg bw of the test substance was held in contact with the dorsum of the animals under an occlusive cuff for 24 hours. Animals were observed after exposure for mortality, dermal reactions, and weight changes for a total of 14 days. Gross pathology was performed at study termination. Based on a specific gravity of 0.805, the limit dose of test substance administered in this study was approximately 16 g/kg bw. This dose was significantly higher than the 2000 mg/kg bw limit dose described in OECD Guideline 402.
- Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
- Mortality:
- One female died 3.67 hours after initial application of the test substance. All other animals survived the 14-day observation period.
- Clinical signs:
- other: Two to five hours after initial application of the test substance, moderate weakness was noted in all animals, implying percutaneous absorption of the test substance. No other clinical observations were noted.
- Gross pathology:
- In the female that died during the exposure period, moderate necrosis of the skin of the back and red discoloration of the inguinal hair were noted. The cause of death was not determined.
No treatment-related changes were observed at necropsy in animals which survived the 14-day observation period. Other lesions were not considered treatment-related, and no tissue was collected for microscopic evaluation.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Methyl isopropyl ketone was not acutely toxic by the dermal route in rats under conditions used in this study. A single female died within four hours of test substance application. No cause of death was determined. All other animals survived and gained weight normally. Moderate weakness, a sign of central nervous system depression, was observed in all animals within 2-5 hours of test substance application. No treatment-related changes were observed at necropsy in animals that survived to study termination. The dermal LD50 in rats was > 20.0 mL/kg bw (equivalent to > 16 g/kg bw).
Based on an acute dermal LD50 value of > 20.0 mL/kg bw in male and female rats, methyl isopropyl ketone is not classified for Acute Toxicity by the dermal route under the UN GHS regulations or the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. 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. - Executive summary:
In an acute dermal toxicity study, 5 rats/sex were exposed to 20 mL/kg bw of methyl isopropyl ketone under occlusive contact for 24 hours. Under the conditions of this study, one death occurred and the dermal LD50 was considered to be > 20.0 mL/kg bw. Signs of irritation in the female that died during exposure were limited to moderate necrosis at the application sites. A body weight gain was noted for all surviving animals over the 2-week observation period. Based on the results of this study, methyl isopropyl ketone is not expected to be acutely toxic upon skin contact under conditions of normal use; however, methyl isopropyl ketone may be absorbed through the skin and dermal exposure to large volumes for prolonged periods of time may cause central nervous system effects.
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.