Registration Dossier

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