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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 600 mg/m³
- Most sensitive endpoint:
- neurotoxicity
DNEL related information
- DNEL derivation method:
- other: EU indicative occupational exposure limit (8-hour)
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: EU indicative occupational exposure limit (8-hour)
- Value:
- 600 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No adjustment required.
- AF for dose response relationship:
- 1
- Justification:
- No adjustments required for dose response relationship as DNEL is based on an occupational limit for workers.
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustments required for exposure duration as DNEL is based on an occupational limit for workers.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No adjustments required for interspecies differences (allometric scaling), exposure duration, dose response or quality of whole database as DNEL is based on an occupational limit for workers.
- AF for other interspecies differences:
- 1
- Justification:
- No adjustments required for other interspecies differences as DNEL is based on an occupational limit for workers.
- AF for intraspecies differences:
- 1
- Justification:
- No adjustments required for intraspecies differences as DNEL is based on an occupational limit for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- No adjustments required for quality of whole database as DNEL is based on an occupational limit for workers.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 900 mg/m³
DNEL related information
- DNEL derivation method:
- other: EU indicative occupational exposure limit (15-minute)
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: EU indicative occupational exposure limit (15-minute)
- Value:
- 900 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No adjustment required.
- AF for dose response relationship:
- 1
- Justification:
- No adjustments required for dose response relationship as DNEL is based on an occupational limit for workers.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No adjustments required for interspecies differences (allometric scaling) as DNEL is based on an occupational limit for workers.
- AF for other interspecies differences:
- 1
- Justification:
- No adjustments required for other interspecies differences as DNEL is based on an occupational limit for workers.
- AF for intraspecies differences:
- 1
- Justification:
- No adjustments required for intraspecies differences as DNEL is based on an occupational limit for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- No adjustments required for quality of whole database as DNEL is based on an occupational limit for workers.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 161 mg/kg bw/day
- Most sensitive endpoint:
- neurotoxicity
DNEL related information
- DNEL derivation method:
- other: EU indicative occupational exposure limit (8-hour)
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: EU indicative occupational exposure limit (8-hour)
- Value:
- 600 mg/m³
- Modified dose descriptor starting point:
- other: modified EU indicative occupational exposure limit (8-hour)
- Value:
- 1 161 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Absorption correction – see absorption data below:
Inhalation: Ibriani et al., 1989 reported 54% retention from inhalation exposures.
Dermal: dermal absorption of MEK, in vivo, was reported to be 4%. (NIOSH, 2002).
Therefore the IOEL can be adjusted for absorption by a factor of 54%/4%.
Starting point 8-hour IOEL of 600 mg/m³ Modified DNEL 600 mg/m³ x 10 m³/d/ 70 kg x 54%/4% = 1161 mg/kg bw/day
References
Imbriani, M., Ghittori, S., Pezzagno, G., & Capodaglio, E. (1989). Methyl ethyl ketone (MEK) in urine as biological index of exposure. Giornale italiano di medicina del lavoro, 11(6), 255-261.
NIOSH (2002) https://www.cdc.gov/niosh/docs/2003-154/pdfs/8319.pdf
- AF for dose response relationship:
- 1
- Justification:
- No adjustments required for dose response relationship as DNEL is based on an occupational limit for workers.
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustments required for exposure duration as DNEL is based on an occupational limit for workers.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No adjustments required for interspecies differences (allometric scaling) as DNEL is based on an occupational limit for workers.
- AF for other interspecies differences:
- 1
- Justification:
- No adjustments required for other interspecies differences as DNEL is based on an occupational limit for workers.
- AF for intraspecies differences:
- 1
- Justification:
- No adjustments required for intraspecies differences as DNEL is based on an occupational limit for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- No adjustments required for quality of whole database as DNEL is based on an occupational limit for workers.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 106 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: DNEL derived from worker EU indicative occupational exposure limit (8-hour)
- Overall assessment factor (AF):
- 2
- Dose descriptor starting point:
- other: EU indicative occupational exposure limit (8-hour)
- Value:
- 600 mg/m³
- Modified dose descriptor starting point:
- other: EU indicative occupational exposure limit (8-hour) corrected for exposure duration, frequency and respiratory volume
- Value:
- 212 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction for exposure duration = 8 hours/day to 24 hours/day
Correction for exposure frequency = 5 days/week to 7 days/week
Correction for respiratory volume = 10/6.7
Therefore the corrected DNEL = 600 mg/ m³ x 8/24 x 5/7 x 10/6.7 = 212 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- No adjustments required for dose response relationship as DNEL is based on an occupational limit for workers, ccorrected for exposure duration, frequency and respiratory volume.
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustments required for exposure duration as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No adjustments required for interspecies differences (allometric scaling) as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for other interspecies differences:
- 1
- Justification:
- No adjustments required for other interspecies differences as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for intraspecies differences:
- 2
- Justification:
- Default, worker to general population: when extrapolating from animal to human, the recommended AF is 10 for general population and 5 for worker. Since the starting dose is the worker IOEL corrected for continuous exposure an additional 2-fold AF for differences is considered sufficient.
- AF for the quality of the whole database:
- 1
- Justification:
- No adjustments required for quality of the whole database as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 450 mg/m³
DNEL related information
- DNEL derivation method:
- other: DNEL derived from worker EU indicative occupational exposure limit (15-minute)
- Overall assessment factor (AF):
- 2
- Dose descriptor starting point:
- other: EU indicative occupational exposure limit (15-minute)
- Value:
- 900 mg/m³
- Modified dose descriptor starting point:
- other: EU indicative occupational exposure limit (15-minute) corrected for respiratory volume
- Value:
- 900 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No correction required for exposure duration or frequency.
- AF for dose response relationship:
- 1
- Justification:
- No adjustments required for dose response relationship as DNEL is based on an occupational limit for workers.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No adjustments required for interspecies differences (allometric scaling) as DNEL is based on an occupational limit for workers.
- AF for other interspecies differences:
- 1
- Justification:
- No adjustments required for other interspecies differences as DNEL is based on an occupational limit for workers.
- AF for intraspecies differences:
- 2
- Justification:
- Default, worker to general population: when extrapolating from animal to human, the recommended AF is 10 for general population and 5 for worker. Since the starting dose is the worker IOEL corrected for respiratory volume an additional 2-fold AF for differences is considered sufficient.
- AF for the quality of the whole database:
- 1
- Justification:
- No adjustments required for quality of the whole database as DNEL is based on an occupational limit for workers.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 412 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: DNEL derived from EU indicative occupational exposure limit (8-hour)
- Overall assessment factor (AF):
- 2
- Dose descriptor starting point:
- other: EU indicative occupational exposure limit (8-hour)
- Value:
- 600 mg/m³
- Modified dose descriptor starting point:
- other: modified EU indicative occupational exposure limit (8-hour)
- Value:
- 823.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Absorption correction – see absorption data below:
Inhalation: Ibriani et al., 1989 reported 54% retention from inhalation exposures.
Dermal: dermal absorption of MEK, in vivo, was reported to be 4%. (NIOSH, 2002).
Therefore the IOEL can be adjusted for absorption by a factor of 54%/4%.
Starting point 8-hour IOEL of 600 mg/m³
8-hour IOEL corrected for exposure duration, frequency and respiratory volume = 212 mg/m³
Modified DNEL = 212 mg/m³ x 20 m³/d/70 kg x 54%/4% (Absorption correction) = 823.5 mg/kg bw/day
Reference: Imbriani, M., Ghittori, S., Pezzagno, G., & Capodaglio, E. (1989). Methyl ethyl ketone (MEK) in urine as biological index of exposure. Giornale italiano di medicina del lavoro, 11(6), 255-261.
- AF for dose response relationship:
- 1
- Justification:
- No adjustments required for dose response relationship as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustments required for exposure duration as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No adjustments required for interspecies differences (allometric scaling) as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for other interspecies differences:
- 1
- Justification:
- No adjustments required for other interspecies differences as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for intraspecies differences:
- 2
- Justification:
- Default, worker to general population: when extrapolating from animal to human, the recommended AF is 10 for general population and 5 for worker. Since the starting dose is the worker IOEL corrected for continuous exposure an additional 2-fold AF for differences is considered sufficient.
- AF for the quality of the whole database:
- 1
- Justification:
- No adjustments required for quality of the whole database as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 31 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: DNEL derived from EU indicative occupational exposure limit (8-hour)
- Overall assessment factor (AF):
- 2
- Dose descriptor starting point:
- other: EU indicative occupational exposure limit (8-hour)
- Value:
- 61 mg/kg bw/day
- Modified dose descriptor starting point:
- other: Modified EU indicative occupational exposure limit (8-hour)
- Explanation for the modification of the dose descriptor starting point:
Starting point 8-hour IOEL of 600 mg/m³
8-hour IOEL corrected for exposure duration, frequency and respiratory volume = 212 mg/m³ Modified DNEL Oral = 212 mg/m³ x 20 m³/day/70 kg = 61 mg/kg bw/day (no adjustment for absorption)
- AF for dose response relationship:
- 1
- Justification:
- No adjustments required for dose response relationship as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for differences in duration of exposure:
- 1
- Justification:
- No adjustments required for duration of exposure as DNEL is based on an occupational limit for worke rs, corrected for exposure duration, frequency and respiratory volume.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No adjustments required for interspecies differences (allometric scaling) as DNEL is based on an occ upational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for other interspecies differences:
- 1
- Justification:
- No adjustments required for other interspecies differences as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for intraspecies differences:
- 2
- Justification:
- Default, worker to general population: when extrapolating from animal to human, the recomme nded AF is 10 for general population and 5 for worker. Since the starting dose is the worker IOEL a mortised for continuous exposure an additional 2-fold AF for differences is considered sufficient.
- AF for the quality of the whole database:
- 1
- Justification:
- No adjustments required for quality of the whole database as DNEL is based on an occupational limit for workers, corrected for exposure duration, frequency and respiratory volume.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)