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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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