Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
200.196 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
9 960 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
5 004.9 mg/m³
Explanation for the modification of the dose descriptor starting point:

The selected dose descriptor chose for the DNEL derivation is the NOAEC from a Klimisch 1 study (OECD 413, GLP), 90 days inhalation study on rats.

The DNEL for systemic effects via the inhalation route is deri ved on the NOAEC from the inhalation 90-day study in which the NOAEC was 9960mg/m3. Correction for respiratory rate and volume (rat to human worker): (6.7m3/d/10m3/d). (calculation from the REACH guidance "Chapter R.8: Characterisation of dose [concentration]-response for human health", page 69, example A.2) Correction for differences between human and experimental exposure conditions (worker)=0.75 (by default in DNEL calculator, corresponds to the ratio 6h/d/8h/d - guidance p 30) Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is 9960mg/ m3*(6.7m3/10m3) *0.75 =5004.9mg/m3.

AF for dose response relationship:
1
Justification:
Default (NOAEL highest dose tested)
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (Oral rat to inhaled human)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default (GLP study, following guideline OECD 413 without restriction)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
200.196 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

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:
DNEL (Derived No Effect Level)
Value:
3.26 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
9 960 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
3 052.28 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

[TO AMEND BASED ON NEW DNEL] The selected dose descriptor chose for the DNEL derivation is the NOAEC from a Klimisch 1 study (OECD 413, GLP), 90 days inhalation study on rats. One study is available for oral repeated toxicity but it is of very low quality (Klimish 4), with NOAEL = 26mg/kgbw/day (knowing that this is the highest dose tested and that no effects were observed). Therefore the most relevant toxicity descriptor is the NOAEC of 9960mg/m3. The DNEL for systemic effects via the dermal route is then derived on the NOAEC from the inhalation 90-day study in which the NOAEC was 9960 mg/m3. Corrected dermal NOAEL = inhalatory NOAEC x sRVrat x (ABSinh-rat/ABSoral-human) (calculation from the REACH guidance "Chapter R.8: Characterisation of dose [concentration]-response for human health", page 72, example B.4) ABS=absorption rate: ABSinh-rat= 100% (by default) ABSoral-human=93% (toxicokinetics data) sRV rat= standard respiratory volume. For a 8h exposure =0.38m3/kgbw

Corrected dermal NOAEL = 9960mg/m3 x 0.38m3/kgbw x (100/93)=4069.7mg/kgbw/day Correction for differences between human and experimental exposure conditions (worker)=0.75 (by default in DNEL calculator) Therefore the NOAEL rat for repeated-dose systemic effects via the dermal route is =4069.7 X 0.75 = 3052.28 mg/kgbw/day

AF for dose response relationship:
1
Justification:
Default (NOAEL highest dose tested)
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (oral rat to dermal human)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default (GLP study, following guideline OECD 413 without restriction)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.26 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

There are no consumer uses of methyltetrahydrofuran, therefore DNELs for the dermal and inhalation routes are not required. A DNEL for the oral route is calculated for the purposes of assessment of humans exposed via the environment

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
DNEL related information
Explanation for the modification of the dose descriptor starting point:

There are no consumer uses of methyltetrahydrofuran, therefore DNELs for the dermal and inhalation routes are not required. A DNEL for the oral route is calculated for the purposes of assessment of humans exposed via the environment

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

There are no consumer uses of methyltetrahydrofuran, therefore DNELs for the dermal and inhalation routes are not required. A DNEL for the oral route is calculated for the purposes of assessment of humans exposed via the environment

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:
1.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
2 199.28 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

[TO AMEND BASED ON NEW DNEL]

The selected dose descriptor chose for the DNEL derivation is the NOAEC from a Klimisch 1 study (OECD 413, GLP), 90 days inhalation study on rats. One study is available for oral repeated toxicity but it is of very low quality (Klimish 4), with NOAEL = 26mg/kgbw/day (knowing that this is the highest dose tested and that no effects were observed). Therefore the most relevant toxicity descriptor is the NOAEC of 9960mg/m3. The DNEL for systemic effects via the dermal route is then derived on the NOAEC from the inhalation 90-day study in which the NOAEC was 9960 mg/m3. Corrected dermal NOAEL = inhalatory NOAEC x sRVrat x (ABSinh-rat/ABSoral-human) (calculation from the REACH guidance "Chapter R.8: Characterisation of dose [concentration]-response for human health", page 72, example B.4) ABS=absorption rate: ABSinh-rat= 100% (by default) ABSoral-human=93% (toxicokinetics data) sRV rat= standard respiratory volume. For a 24h exposure (general population exposure) =1,15m3/kgbw Corrected dermal NOAEL = 9960mg/m3 x 1,15m3/kgbw x (100/93)=12316mg/kgbw/day Correction for differences between human and experimental exposure conditions: 0.178571 (by default in DNEL calculator) Therefore the NOAEL rat for repeated-dose systemic effects via the dermal route (general population) is = 12316 X 0.178571= 2199.28mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default (NOAEL highest dose tested)
AF for differences in duration of exposure:
2
Justification:
Default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (oral rat to oral human)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default (GLP study, following guideline OECD 413 without restriction)
AF for remaining uncertainties:
1
Justification:
Default (no remaining uncertainties)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 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):
200
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

Short-term high exposures are considered unlikely (no specific uses implying high short-term exposure), DNELs for long-term exposure are therefore adequate to protect against short-term exposures and no separate short-term DNELs are calculated.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

There are no consumer uses of methyltetrahydrofuran, therefore DNELs for the dermal and inhalation routes are not required. A DNEL for the oral route is calculated for the purposes of assessment of humans exposed via the environment