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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study conducted according to acceptable scientific standards and reviewed by Quality Assurance, although conduct of study according to all aspects of GLP could not be 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:
- Groups of male Hartley guinea pigs were used to determine the dermal sensitization potential of the test substance using the Kodak Footpad Method. Initially, the irritant potential of a 1% solution of the substance in a 7:2:1 mixture of acetone, dioxane, and guinea pig fat was determined following application to the clipped back skin of several animals. The results of the preliminary irritation study were used to determine the concentration of the test substance to be used in the sensitization study. In the sensitization study proper, groups of ten animals were induced by injection of 0.05 mL of either a 1% solution of the substance in Freund's Complete Adjuvant, or 0.05 mL of Freund's Complete Adjuvant alone. The injections were made into one footpad for each animal. Seven days later, both groups of animals were challenged topically with 0.5 mL of a 10% solution of the test substance in the mixture of acetone, dioxane, and guinea pig fat described above. After 48 hours, the responses in animals induced with 1% compound in Freund's were compared to the responses in animals induced with Freund's only. The numbers of animals demonstrating a response in each group were recorded, and responses were noted as slight, moderate, or strong. The negative control animals, i.e., those induced with Freund's alone, were used to quantify responses associated with Freund's only. The number of animals responding to challenge and the degree of positive response were used to determine the sensitization potential of the test substance.
- GLP compliance:
- not specified
- Type of study:
- other: Kodak Footpad Method. The Kodak Footpad method was listed as an alternate method for evaluating dermal sensitization in the first edition of the OECD Guideline for evaluating dermal sensitization.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- -Strain: Crl(HA)BR Hartley
-Body weight (Irritation phase): 403-538 g
-Initial body weight (Induction and Challenge Phase): 300-343 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Irritation and challenge phases: 7:2:1 acetone:dioxane:guinea pig fat; Induction phase: Freund's Complete Adjuvant
- Concentration / amount:
- Preliminary Irritation Phase: 1.0% in acetone + dioxane + guinea pig fat.
Induction Phase: 1.0% in Freund's Complete Adjuvant
Challenge Phase: 10.0% in acetone + dioxane + guinea pig fat.
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: Irritation and challenge phases: 7:2:1 acetone:dioxane:guinea pig fat; Induction phase: Freund's Complete Adjuvant
- Concentration / amount:
- Preliminary Irritation Phase: 1.0% in acetone + dioxane + guinea pig fat.
Induction Phase: 1.0% in Freund's Complete Adjuvant
Challenge Phase: 10.0% in acetone + dioxane + guinea pig fat.
- No. of animals per dose:
- 10
- Details on study design:
- Groups of male Hartley guinea pigs were used to determine the dermal sensitization potential of the test substance using the Kodak Footpad Method. Initially, the irritant potential of a 1% solution of the substance in a 7:2:1 mixture of acetone, dioxane, and guinea pig fat was determined following application to the clipped back skin of several animals. These animals were not used in the study proper, but were used only to estimate the irritant potential of the test substance, and to help in the determination of the concentration of test substance to be used in the sensitization study. In the subsequent sensitization study, groups of ten animals were induced by injection of 0.05 mL of either a 1% solution of the substance in Freund's Complete Adjuvant, or 0.05 mL of Freund's alone. Injections were made into the animal's footpad. Seven days later, the backs of the animals were clipped and both groups of animals were challenged topically with 0.5 mL of a 10% solution of the test substance in the mixture of acetone, dioxane, and guinea pig fat described above. Animals were depilated after 24 hours to assist in the determination of dermal responses. After both 24 and 48 hours, the responses in animals induced with 1% compound in Freund's were compared to the responses in animals induced with Freund's only. The numbers of animals demonstrating a response in each group were recorded, and responses were noted as slight, moderate, or strong. The negative control animals, i.e., those induced with Freund's alone, were used to quantify responses associated with the irritant potential of Freund's only. The number of animals responding to challenge and the degree of positive response were used to determine the sensitization potential of the test substance.
- Challenge controls:
- 10 male Hartley guinea pigs induced with Friend's Complete Adjuvant only.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No reactions were observed at challenge in animals previously induced with the test substance in Freund's Complete Adjuvant.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No reactions were observed at challenge in animals previously induced with the test substance in Freund's Complete Adjuvant..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No reactions were observed at challenge in animals previously induced with the test substance in Freund's Complete Adjuvant.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No reactions were observed at challenge in animals previously induced with the test substance in Freund's Complete Adjuvant..
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Both the test group and the control group treated with Freund’s Complete Adjuvant alone had similar responses when tested using the Kodak Footpad Method. Under conditions used in this study, methyl isopropyl ketone was not a dermal sensitizer.
Based on an absence of a positive sensitization reaction in this study, methyl isopropyl ketone is not classified for Skin Sensitization according to GHS. - Executive summary:
In a dermal sensitization study using the Kodak Footpad Method, groups of ten male Hartley guinea pigs were induced by injection in the footpad with either 0.5 mL of a 1.0% solution of methyl isopropyl ketone in Freund's Complete Adjuvant or 0.5 mL of Freund's alone. One week later, the animals were challenged with a 10% solution of methyl isopropyl ketone in acetone: dioxane: guinea pig fat (7:2:1). The 10.0% solution was used since a 1% solution of the test substance in the same solvent was found to be non-irritating in the preliminary irritation study. Twenty-four and forty-eight hours after challenge, all animals in the control and test groups appeared normal, and no positive dermal reactions were observed. Based on the results of this study using the Kodak Footpad Method, it was determined that methyl isopropyl ketone was not a dermal sensitizer.
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