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EC number: 201-159-0 | CAS number: 78-93-3
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- year not reported; reliability scoring based on 1992 guideline
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler/Guinea Pig Maximisation test method.
Test material
- Reference substance name:
- Butanone
- EC Number:
- 201-159-0
- EC Name:
- Butanone
- Cas Number:
- 78-93-3
- Molecular formula:
- C4H8O
- IUPAC Name:
- butan-2-one
- Details on test material:
- - Name of test material (as cited in study report): Methyl ethyl ketone
- Physical state: Colorless liquid
- Analytical purity: 99.7%
- Lot/batch No.: F113600445
- Expiration date of the lot/batch: 22 November 1996
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall Ltd.
- Age at study initiation: 4 to 6 weeks old
- Weight at study initiation: 343 to 403 g
- Housing: Up to five guinea pigs were accommodated in suspended polypropylene cages with a solid floor relined with a whitewood bedding.
- Diet (e.g. ad libitum): SQC FD1 (pelleted) diet from Special Diets Services Ltd., Witham was freely available to the animals at all times
- Water (e.g. ad libitum): Mains water was provided, ad libitum, via cage mounted water bottles
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22°C
- Humidity (%): 40-80% RH
- Air changes (per hr): at least 10 air changes per hour
- Photoperiod (hrs dark / hrs light): illuminated by flourescent strip-lights for 14 hrs daily.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 1.) Induction phase:
test group: undiluted test substance (0.3 mL)
control: 0.3 mL Alembicol D
2.) Challenge phase:
test group and control: test substance is undiluted and 50% m/m dilution in Alembicol D.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 1.) Induction phase:
test group: undiluted test substance (0.3 mL)
control: 0.3 mL Alembicol D
2.) Challenge phase:
test group and control: test substance is undiluted and 50% m/m dilution in Alembicol D.
- No. of animals per dose:
- 20 in treatment group and 10 in control group.
- Details on study design:
- RANGE FINDING TESTS:
Screening test for induction
Five formulations, incorporating from 20% m/m in Alembicol D up to the maximum practical concentration, undiluted test article, were selected. The dorsum and flanks of two guinea pigs were clipped on the day before application of the test formulations. The same area was shaved shortly prior to treatment. The animals were subject to occluded, topical application of five 20 x 20 mm patches of Whatman No 4 filter paper each saturated with approximately 0.2 mL of one of the test formulations. Occlusion was effected by covering the Whatman patches with successive layers of "Blenderm" adhesive dressing from 3M Co, Loughborough, aluminium foil and "Steroban" open-weave, elasticated bandage from Steroplast Ltd, Bredbury. The last layer completely enveloped the torso to ensure the patches remained secure. The dressings and bandages were removed approximately 24 hours after application and the location of each patch was marked with indelible ink. Treated areas of skin were reshaved approximately 21 hours after removal of the bandages. Dermal reactions were assessed approximately 2, 24, and 48 hours after removal of the patches and the results were recorded individually.
Screening test for challenge application
Four formulations, 25, 50, and 75% m/m in Alembicol D and undiluted test article, were chosen based on the results of the first screen to identify the maximum non-irritant concentration of test article after occluded, topical application to skin. The flanks of three guinea pigs were clipped on the day before application. The same areas were shaved approximately two hours before treatment. Each animal was subject to occluded topical application of four 12 mm Finn Chambers from Biodiagnostics Ltd, Upton-upon-Severn, each loaded with approximately 0.1 mL of one of the four selected test formulations. The Finn Chambers were secured by successive applications of Blenderm and Steroban. The dressings and chambers were removed after six hours and the treated areas of skin were washed with water. The location of each challenge site was marked on the skin using indelible ink. The treated areas of skin were reshaved approximately 21 hours after removal of the chambers. Dermal reactions were assessed 24 and 48 hours after removal of the chambers.
No reactions were elicited by the undiluted test article nor by any of the lower applied concentrations.
MAIN STUDY:
Control group: left side of flank induced with vehicle and challenged with vehicle; right side of flank not induced but challenged with test substance (undiluted and 50% mixture in vehicle).
Test group: left side of flank induced with test substance and challenged with vehicle; right side not induced but challenged with test substance (undiluted and 50% mixture in vehicle).
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 24 hours
- Test groups: 20 females were treated with 0.3 mL of undiluted methyl ethyl ketone on left flank.
- Control group: 10 females were treated with 0.3 mL of Alembicol D (vehicle) on left flank.
- Site: Left flank
- Frequency of applications: Days 1, 8, and 15.
- Duration: 3 weeks
- Concentrations: 0.3 mL undiluted methyl ethyl ketone or vehicle.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Animals were challenged at Day 29
- Exposure period: 6 hours
- Test groups: Animals were tested on the left flank with Alembicol D (vehicle) and on the right flank with undiluted methyl ethyl ketone and a 50% m/m dilution in Alembicol D (vehicle); a volume of 0.1 mL was used for challenge.
- Control group: Animals were tested on the left flank with Alembicol D (vehicle) and on the right flank with undiluted methyl ethyl ketone and a 50% m/m dilution in Alembicol D (vehicle); a volume of 0.1 mL was used for challenge.
- Site: Left flank for challenge with Alembicol D (vehicle) and right flank for challenge with methy ethyl ketone (undiluted and 50% dilution).
- Concentrations: undiluted methyl ethyl ketone and 50% m/m dilution in Alembicol D.
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- The control group was challenged with both the vehicle and the test article to determine any unusual response in animals induced with vehicle.
- Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- Positive control results with alpha-hexylcinnamaldehyde provided in Appendix 1 (pg 25); however, study report states that regular (six monthly) testing to confirm susceptibility of guinea pigs to 2-mercaptobenzothiazole were performed (pg 8). It is unclear what positive control compound was used in this study.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- focal eschar in one animal at anterior site exposed to undiluted methyl ethyl ketone
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: focal eschar in one animal at anterior site exposed to undiluted methyl ethyl ketone.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 (vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control. Dose level: 0 (vehicle). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 (vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control. Dose level: 0 (vehicle). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- undiluted
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- slight erythema in 1 animal at anterior site exposed to undiluted methyl ethyl ketone (authors judged this response as inconclusive); necrotic focus on dose site in 1 animal at anterior site exposed to undiluted methyl ethyl ketone.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: slight erythema in 1 animal at anterior site exposed to undiluted methyl ethyl ketone (authors judged this response as inconclusive); necrotic focus on dose site in 1 animal at anterior site exposed to undiluted methyl ethyl ketone..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- focal eschar (appeared to be scabs over pre-existing spots rather than treatment effects) noted in two animals at anterior site exposed to undiluted methyl ethyl ketone.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: focal eschar (appeared to be scabs over pre-existing spots rather than treatment effects) noted in two animals at anterior site exposed to undiluted methyl ethyl ketone..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- slight erythema (barely perceptible) in one animal at the posterior site exposed to methyl ethyl ketone, 50% m/m in Alembicol D (the authors judged this response to be inconclusive).
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight erythema (barely perceptible) in one animal at the posterior site exposed to methyl ethyl ketone, 50% m/m in Alembicol D (the authors judged this response to be inconclusive)..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 (vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 (vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Undiluted methyl ethyl ketone elicited a slight erythematous response in one of the test animals following the challenge application. This response was deemed inconclusive. The results for the remaining guinea pigs were negative. Under the conditions of the study, MEK was not considered to be a skin sensitiser in guinea pigs.
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