Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
260 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: EU Occupational Exposure Limit
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
other: OEL
Value:
260 mg/m³
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: EU Occupational Exposure Limit
Overall assessment factor (AF):
5
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/(24 x 4) = 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 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
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:
8 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