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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
142 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Modified dose descriptor starting point:
LOAEC
Value:
2 125 mg/m³
Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation required: Inhalation - Inhalation. The starting point of 3171 mg/m3 was adjusted to light work by multiplying by 0.67 according to ECHA guidance.
AF for dose response relationship:
3
Justification:
Default value from ECHA guidance for LOAEC to NOAEC extrapolation.
AF for differences in duration of exposure:
1
Justification:
Acute effect - no time extrapolation is appropriate.
AF for interspecies differences (allometric scaling):
1
Justification:
According to ECHA guidance, no allometric scaling necessary for inhalation.
AF for other interspecies differences:
1
Justification:
According to ECHA guidance, no interspecies extrapolation necessary for inhalation.
AF for intraspecies differences:
5
Justification:
Default value from ECHA guidance.
AF for the quality of the whole database:
1
Justification:
The results of a chronic study on the read-across substance, tetrahydrofuran, provides robust evidence of a lack of significant systemic toxicity.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
142 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Modified dose descriptor starting point:
LOAEC
Value:
2 125 mg/m³
Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation required: Inhalation - Inhalation. The starting point of 3171 mg/m3 was adjusted to light work by multiplying by 0.67 according to ECHA guidance.
AF for dose response relationship:
3
Justification:
Default value from ECHA guidance for LOAEC to NOAEC extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
According to ECHA guidance, no allometric scaling necessary for inhalation.
AF for other interspecies differences:
1
Justification:
According to ECHA guidance, no interspecies extrapolation necessary for inhalation.
AF for intraspecies differences:
5
Justification:
Default value from ECHA guidance.
AF for the quality of the whole database:
1
Justification:
The results of a chronic study on the read-across substance, tetrahydrofuran, provides robust evidence of a lack of significant systemic toxicity.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
142 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor:
LOAEC
AF for dose response relationship:
3
Justification:
Default value from ECHA guidance for LOAEC to NOAEC extrapolation.
AF for differences in duration of exposure:
1
Justification:
Acute effect - no time extrapolation is appropriate.
AF for interspecies differences (allometric scaling):
1
Justification:
According to ECHA guidance, no allometric scaling necessary for inhalation.
AF for other interspecies differences:
1
Justification:
According to ECHA guidance, no interspecies extrapolation necessary for inhalation.
AF for intraspecies differences:
5
Justification:
Default value from ECHA guidance.
AF for the quality of the whole database:
1
Justification:
The results of a chronic study on the read-across substance, tetrahydrofuran, provides robust evidence of a lack of significant systemic toxicity.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
142 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor starting point:
LOAEC
AF for dose response relationship:
3
Justification:
Default value from ECHA guidance for LOAEC to NOAEC extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
According to ECHA guidance, no allometric scaling necessary for inhalation.
AF for other interspecies differences:
1
Justification:
According to ECHA guidance, no interspecies extrapolation necessary for inhalation.
AF for intraspecies differences:
5
Justification:
Default value from ECHA guidance.
AF for the quality of the whole database:
1
Justification:
The results of a chronic study on the read-across substance, tetrahydrofuran, provides robust evidence of a lack of significant systemic toxicity.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation made. Assume 100% of dermal exposure is absorbed through the skin.
AF for dose response relationship:
1
Justification:
No adjustment needed. NOAEL used as the starting point.
AF for differences in duration of exposure:
1
Justification:
Study is a 2-generation reproduction study. NOAEL applies to F0 and F1 generations, spanning exposures well beyond 90 days; default AF assigned.
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling for rat from ECHA guidance.
AF for other interspecies differences:
1
Justification:
According to ECHA guidance, no interspecies extrapolation necessary.
AF for intraspecies differences:
5
Justification:
Worker default AF from ECHA guidance.
AF for the quality of the whole database:
1
Justification:
The results of a chronic study on the read-across substance, tetrahydrofuran, provides robust evidence of a lack of significant systemic toxicity.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

Tetrahydro-3-methylfuran (3-methyl-THF) is imported into the EU as a monomer in a finished polymer and, therefore, does not present a hazard to workers in this form. Nonetheless, worker DNELs have been derived in the event that it becomes necessary to import the monomer itself. Although data on 3-methyl-THF are limited, appropriate DNELs can nonetheless be derived with support from the read-across substance, tetrahydrofuran. For inhalation exposures, data from 3-methyl-THF itself were used to derive the short-term DNELs covering local and systemic effects. And, given that the short-term DNEL was lower than the long-term systemic DNEL derived from the read-across substance, it was concluded that the short-term DNEL would be adequately protective on long-term systemic effects and should be used as the long-term DNEL. For long-term dermal exposures (systemic effects), data from the read-across substance were used. For long-term and acute local skin and eye effects, it was concluded that no threshold could be determined and no DNELs could be derived given that the substance is severely irritating or corrosive to skin and causes irreversible effects on the eye.

General Population - Hazard via inhalation 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
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:
no hazard identified
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

Tetrahydro-3-methylfuran (3-methyl-THF) is imported into the EU as a monomer in a finished polymer and, therefore, presents no hazard to the general population.