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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
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- Nanomaterial pour density
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- 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
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
The following information is taken into account for any hazard / risk assessment:
Information on the acute oral toxicity of methyl ethyl ketone was obtained from data on the read across substance , secondary butanol. Secondary butanol is reported to have low acute oral toxicity following oral administration. Reported oral LD50 values of secondary butanol were 2054 mg/kg body weight for males and 2328 mg/kg body weight for females in a study performed similar to test guidelines and in compliance with good laboratory practice. The overall calculated oral LD50 in rats was 2193 mg/kg body weight. Clinical signs included gait and/or posture abnormalities in all rats at all dose levels. In the higher dose groups some rats were comatose or prostrate within a few hours of dosing, with some animals being unconscious for 24 hours or more. In a supporting study, the oral LD50 for the registered substance itself, methyl ethyl ketone, in female Harlan-Wistar rats is reported to be 3460 mg/kg body weight (Cox, 1976); although the study does not meet the criteria of current guidelines for acute oral toxicity, it supports the conslusion that the substance is not acutely toxic via the oral router.
The dermal LD50 for methyl ethyl ketone in male rabbits was
reported by Smyth et al. (1962). As discussed below, the study is
lacking details, but is deemed reliable. The dermal LD50 in male rabbits
is reported to be greater than 10 mL/kg body weight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation, for read-across substance
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- -reliability scoring was based on 2001 guideline
- Deviations:
- yes
- Remarks:
- -insignificant deviation, guideline suggests using animals of all the same sex; no necropsy conducted
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: Weight on Day 1 = 189 to 219 g (males) and 125 to 149 g (females)
- Fasting period before study: Fasted overnight (18 h) prior to dosing.
- Housing: Two days before dosing, the rats to be used were housed in groups of 2 or 3 animals of the same sex per cage.
- Diet (e.g. ad libitum): Food (PRD, Labsure Animal Foods, Dorset), ad libitum
- Water (e.g. ad libitum): Filtered but untreated water from the public supply, ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): air temperature was 19 to 25 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: not reported
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Range finding studies were performed. - Doses:
- 950, 1200, 1500, 2000, and 2400 mg/kg
- No. of animals per sex per dose:
- 5 rats/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed for clinical signs over 14 days. Body weight measurements were recorded on Days 1, 7, and 14.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Statistics:
- Acute oral LD50 values were calculated using probit analysis (Finney, 1977).
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 054 other: mg/kg
- Remarks on result:
- other: 95% fiducial limits were 1283 - 4018 mg/kg
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 328 other: mg/kg
- Remarks on result:
- other: 95% fiducial limits were 1470 - 5428 mg/kg
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 193 other: mg/kg
- Remarks on result:
- other: 95% fiducial limits were 1608 - 4146 mg/kg
- Mortality:
- Over the 14-day observation period, 0, 1, 2, 1, and 8 animals died in the 950, 1200, 1500, 2000, and 2400 mg/kg dose groups, respectively. For more details, refer to Table 1 (attached).
- Clinical signs:
- other: All rats at all dose levels had gait and/or posture abnormalities. In the higher dose groups some rats were comatose or prostrate within a few hours of dosing, with some animals being unconscious for 24 hours or more. Some rats in the top dose group (2400
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 193 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1962
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study without detailed documentation.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Missing information on test material, test animals, housing conditions, diet, environmental conditions, dermal exposure, vehicle, doses, examinations and measurements. No individual results were reported
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP requirements
- Test type:
- other: Similar to the cuff method of Draize et al.
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: 2.5 to 3.5 kg
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
IN-LIFE DATES:Not reported - Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: entire trunk
- % coverage: Not reported
- Type of wrap if used: Plastic film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Not reported
- Constant volume or concentration used: yes
- For solids, paste formed: Not reported
VEHICLE
No information - Duration of exposure:
- 24 hours
- Doses:
- Not specifically reported. It is reported that, dosages greater than 20 ml/kg can not be retained in contact with the skin.
- No. of animals per sex per dose:
- 4 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: Not reported
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Not reported - Statistics:
- LD50 was reported to be calculated
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 mL/kg bw
- Mortality:
- Not reported
- Clinical signs:
- other: Not reported
- Gross pathology:
- Not reported
- Other findings:
- Not reported
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.
Reference
No tables or results presented
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 8 000 mg/kg bw
Additional information
Acute Toxicity: Oral
Information on the acute oral toxicity of methyl ethyl ketone was obtained from data on the read across substance, secondary butanol. Metabolic data demonstrate that secondary butanol (sBA) is rapidly and extensively converted to methyl ethyl ketone via oxidation of the alcohol functional group by alcohol dehydrogenase in the liver. Thus, methyl ethyl ketone may be used as an appropriate surrogate for sBA and vice versa considering that exposure to either substance would essentially result in exposure to methyl ethyl ketone. The potential acute oral toxicity study of secondary butanol was assessed in Fischer 344 rats in a study similar in methodology to OECD Guidelines for the Testing of Chemicals No. 403 and in compliance with Good Laboratory Practice. Groups of 5 males and 5 females were administered undiluted test article via gavage at dose levels of 950, 1200, 1500, 2000, or 2400 mg/kg body weight. Rats were observed for clinical signs over a 14 day observation period and body weights were measured on days 1, 7, and 14. No animals died in the 950 mg/kg body weight group, one animal died in each of the 1200 and 2000 mg/kg body weight groups, two animals died in the 1500 mg/kg body weight group, and eight animals died in the 2400 mg/kg body weight group. All rats at all dose levels had gait and/or posture abnormalities. In the higher dose groups, some rats were comatose or prostrate within a few hours of dosing, with some animals being unconscious for 24 hours or more. All animals had either died or recovered by day 3. All surviving rats had gained weight relative to their body weights by the end of the 14-day observation period. The LD50 for males was calculated to be 2054 mg/kg body weight with 95% confidence intervals of 1283 to 4018 mg/kg body weight. For females, the LD50 was calculated to be 2328 mg/kg body weight with 95% confidence intervals of 1470 to 5428 mg/kg body weight. Finally, the oral LD50 of secondary butanol for males and females was calculated to be 2193 mg/kg body weight with 95% confidence intervals of 1608 to 4146 mg/kg body weight.
In addition, a supporting study for methyl ethyl ketone is included as a supporting reference. The potential acute oral toxicity of methyl ethyl ketone was assessed in female Harlan-Wistar rats (Cox, 1976). A number of methodology details were not reported; however, rats were administered the test-article by gavage and observed for 14-days for signs of toxicity. The LD50 in female rats was reported to be 4.29 mL/kg body weight. Based on a density of 805.4 g/L, the LD50 was calculated to be 3460 mg/kg body weight. Methyl ethyl ketone was not classified as acutely toxic according to CLP criteria (Registration (EC) No 1272/2008).
Please refer to the document attached to Section 13 for justification of read across.
Acute Toxicity: Dermal
The potential acute dermal toxicity of methyl ethyl ketone was assessed in male New Zealand White rabbits by Smyth et al. (1962). Although this study is lacking in methodological details, the work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, the results reported by this group are deemed reliable. In their investigation, Smyth et al.(1962) administered the test article to the entire trunk of the 4 male animals for 24 hours with an occlusive plastic film. The dermal LD50 of methyl ethyl ketone in male rabbits was determined to be greater than 10 mL/kg body weight.
Methyl ethyl ketone was not classified as acutely toxic following oral exposure according to CLP.
Acute Toxicity: Inhalation
In accordance with column 2 of REACH Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted as acute toxicity studies are available for the oral and dermal routes of exposure.
Justification for classification or non-classification
Acute Toxicity: The substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) NO. 1272/2008.
Specific target organ, Neurotoxicity: According to CLP classification criteria, the substance does meet the criteria for classification and labelling for this endpoint (STOT single exposure category 3, H336 - May cause drowsiness or dizziness), as set out in Regulation (EC) No. 1272/2008.
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.
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