Registration Dossier
Registration Dossier
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EC number: 701-410-9 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 130 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Deutsche Forschungsgemeinschaft (DFG) Maximale Arbeitsplatzkonzentration (MAK) value
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- other: MAK value
- Value:
- 130 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The MAK value was derived based on all the appropriate assessment factors. No further assessment factors applied.
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
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
Additional information - workers
The DNG (2019) MAK value of 130 mg/m3 was recommended to protect against acute neurotoxic effects and mucus membrane irritation. A 4-hour resting NOAEC of 200 mg/m3 was identified based on these effects. Exposure at 100 mg/m3 is not expected to result in acidosis. It is appropriate to use the MAK value as the worker inhalation systemic long-term DNEL.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: DFG MAK value
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- other: MAK value
- Value:
- 130 mg/m³
- Modified dose descriptor starting point:
- other: modifed MAK value
- Value:
- 26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The MAK value was derived based on all the appropriate assessment factors. Since the MAK value already takes into account some human variability, a reduced assessment factor of 5 is applied for intraspecies differences for the general population.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26 400 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: ECHA RAC DNEL (ECHA/RAC/RES-O-0000006324-78-01/F)
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: ECHA RAC DNEL (ECHA/RAC/RES-O-0000006324-78-01/F)
- Value:
- 88 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The ECHA Committee for Risk Assessment (RAC) issued an opinion on methanol (ECHA/RAC/RESO-0000006324-78-01/F; ECHA, 2015). In this opinion, a DNEL for short-term oral exposures was derived based on the minimal oral methanol dose related to severe ocular toxicity; LOAEL = 0.26 g/kg bw. An assessment factor of 3 was applied to this LOAEL to derive a oral short-term systemic DNEL of 0.088 g/kg bw (88 mg/kg bw).
The oral LOAEL is used as the dose descriptor starting point for derivation of the inhalation short-term DNEL:
The REACH standard daily inhalation volume for humans is 20 m³/person/day.
To convert this daily volume to a 15 minute volume: 20 m³/person/day ÷ (24 hr/d x 4-15 min periods/hr) = 0.2 m³/person/15 minutes.
The DNEL of 88 mg/kg bw is equivalent to 5280 mg/person (assuming a body weight of 60 kg).
It follows therefore, that to acheive a dose of 5280 mg/person during 15 minutes of exposure, the inhaled
concentration would need to be: 5280 mg/person ÷ 0.2 m³/person/15 minutes = 26400 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- The basis of the DNEL is a LOAEL, but the RAC DNEL already includes an assessment factor of 3.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- LOAEL is from human data
- AF for other interspecies differences:
- 1
- Justification:
- LOAEL is from human data
- AF for intraspecies differences:
- 1
- Justification:
- RAC (ECHA/RAC/RES-O-0000006324-78-01/F) did not use an assessment factor for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- Default value.
- 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:
- no hazard identified
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:
- 4 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: based on information in methanol disseminated dossier
- Overall assessment factor (AF):
- 5
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The DNG (2019) MAK value of 130 mg/m3 was recommended to protect against acute neurotoxic effects and mucus membrane irritation. A 4-hour resting NOAEC of 200 mg/m3 was identified based on these effects. Exposure at 100 mg/m3 is not expected to result in acidosis. It is appropriate to use the MAK value as the basis for deriving the general population inhalation systemic long-term DNEL.
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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