Registration Dossier
Registration Dossier
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EC number: 251-995-5 | CAS number: 34396-03-7
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
DNEL related information
- DNEL derivation method:
- other: OEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 130 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 130 mg/m³
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 130 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
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
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
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26 400 mg/m³
- Most sensitive endpoint:
- acute toxicity
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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26 400 mg/m³
- 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 = 260 mg/kg bw/day. An assessment factor of 3 was applied to this LOAEL to derive a oral short-term systemic DNEL of 88 mg/kg bw/day.
The oral short-term systemic DNEL 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/(24 x 4) = 0.2 m³/person/15 minutes.
The DNEL of 88 mg/kg bw/day is equivalent to 5280 mg/person/day (assuming a body weight of 60 kg).
Thus, to achieve a dose of 5280 mg/person during 15 minutes of exposure, the inhaled concentration would need to be 26400 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- The basis for 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 based on human data
- AF for other interspecies differences:
- 1
- Justification:
- LOAEL is based on 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:
- the data is based on good quality data
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26 mg/m³
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal 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
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
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
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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.
