Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
130 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:
130 mg/m³
Explanation for the modification of the dose descriptor starting point:

The statutory OEL value of 130 mg/m³ has been 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
Explanation for the modification of the dose descriptor starting point:

The statutory OEL has been derived based on all the appropriate assessment factors. No further assessment factors applied.

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:
26 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 an 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 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 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:
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