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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
225
Modified dose descriptor starting point:
LOAEC
Value:
44 mg/m³
Explanation for the modification of the dose descriptor starting point:
The relevant endpoint is the oral LOAEL of 50 mg/kg bw/d from the screening study. This is extrapolated to an inhalation LOAEC of 44 mg/m3 following correction for breathing rate and activity (/0.38 * 0.67) and for oral absorption of 50% and inhalation absorption of 100%.
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for differences in duration of exposure:
6
Justification:
Extrapolation from a sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Not required (accounted for in route-route extrapolation)
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value (workers)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Modified dose descriptor starting point:
LOAEC
Value:
44 mg/m³
Explanation for the modification of the dose descriptor starting point:
The relevant endpoint is the oral LOAEL of 50 mg/kg bw/d from the screening study. This is extrapolated to an inhalation LOAEC of 44 mg/m3 following correction for breathing rate and activity (/0.38 * 0.67) and for oral absorption of 50% and inhalation absorption of 100%.
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for interspecies differences (allometric scaling):
1
Justification:
Not required (accounted for in route-route extrapolation)
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value (workers)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 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):
900
Modified dose descriptor starting point:
LOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Correction of the starting point (a LOAEL of 50 mg/kg bw/d from an oral study) is not required as oral and dermal absorption are assumed to be comparable.
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for differences in duration of exposure:
6
Justification:
Extrapolation from a sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Use of a rat study
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value (workers)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 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):
150
Modified dose descriptor starting point:
LOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Repeated exposure information via the dermal application route was not available. A subacute endpoint was derived from an orally administered study (30 day and 90day exposure in drinking water), for the subacute duration only. The NOAEL was calculated based on a ppm dose concentration, overall intake and mean bodyweight. The NOAEL estimate was 40 mg/kg bw/day. Another endpoint was derived from a reproductive/developmental toxicity screening test. THe LOAEL from this study was 50 mg/kg bw/day. This was used as the starting point for the derivation of the DNEL by route-to route extrapolation based on the precautionary principle. The local effects of dermal corrosion may be mitigated by use of RMMs, but the overall toxicity profile for 2-ethylaminoethanol suggests short-term peak exposure effects and local corrosivity effects should be protected by a short term DNEL.
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for interspecies differences (allometric scaling):
4
Justification:
Use of a rat study
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value (workers)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The relevant endpoint is the oral LOAEL of 50 mg/kg bw/d from the screening study. This endpoint is used to derive systemic (long-term and short-term) dermal and inhalation DNEL values. The oral endpoint is extrapolated to an inhalation LOAEC of 44 mg/m3 following correction for breathing rate and activity (/0.38 * 0.67) and for oral absorption of 50% and inhalation absorption of 100%. Correction of the starting point is not required for dermal exposure as oral and dermal absorption are assumed to be comparable.

The substance is corrosive, however quantitative endpoints are not available and local dermal and inhalation DNELs are not derived. Inhalation and dermal exposure to the substance should be minimised though the use of engineering controls and protective equipment. 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.05 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
450
Modified dose descriptor starting point:
LOAEC
Value:
22 mg/m³
Explanation for the modification of the dose descriptor starting point:
The relevant endpoint is the oral LOAEL of 50 mg/kg bw/d from the screening study. This is extrapolated to an inhalation LOAEC of 22 mg/m3 following correction for breathing rate (/1.15) and for oral absorption of 50% and inhalation absorption of 100%.
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for differences in duration of exposure:
6
Justification:
Extrapolation from a sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Not required (accounted for in route-route extrapolation)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
LOAEC
Value:
22 mg/m³
Explanation for the modification of the dose descriptor starting point:
The relevant endpoint is the oral LOAEL of 50 mg/kg bw/d from the screening study. This is extrapolated to an inhalation LOAEC of 22 mg/m3 following correction for breathing rate (/1.15) and for oral absorption of 50% and inhalation absorption of 100%.
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for interspecies differences (allometric scaling):
1
Justification:
Not required (accounted for in route-route extrapolation)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 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):
1 800
Modified dose descriptor starting point:
LOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Correction of the starting point (a LOAEL of 50 mg/kg bw/d from an oral study) is not required as oral and dermal absorption are assumed to be comparable.
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for differences in duration of exposure:
6
Justification:
Extrapolation from a sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value (rat study)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 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):
300
Modified dose descriptor starting point:
LOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Repeated exposure information via the dermal application route was not available. A valid subacute endpoint was derived from an orally administered study (30 day and 90day exposure in drinking water), for the subacute duration only. The NOAEL was calculated based on a ppm dose concentration, overall intake and mean bodyweight. The NOAEL estimate was 40 mg/kg bw/day. A more reliable LOAEL of 50 mg/kg bw/day was obtained from a reproductive/developmental toxicity study was used as the starting point for the derivation of the DNEL by route-to route extrapolation based on the precautionary principle. This was used as the starting point for the derivation of the DNEL by route-to route extrapolation based on the precautionary principle. Since no local effects or short-term peak exposure effects were indicated, the long term DNEL is expected to be protective for short term exposure also.
AF for dose response relationship:
3
Justification:
LOAEL used as starting point for DNEL derivation
AF for interspecies differences (allometric scaling):
4
Justification:
default value for rats
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 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):
1 800
Modified dose descriptor starting point:
LOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not required: starting point is a LOAEL from an oral study
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for differences in duration of exposure:
6
Justification:
extrapolation from subacute to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value (rat study)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 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):
300
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
LOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not required: starting point is a LOAEL from an oral study
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for interspecies differences (allometric scaling):
4
Justification:
default value (rat study)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

The relevant endpoint is the oral LOAEL of 50 mg/kg bw/d from the screening study. This endpoint is used to derive systemic (long-term and short-term) dermal, inhalation and oral DNEL values. The oral endpoint is extrapolated to an inhalation LOAEC of 44 mg/m3 following correction for breathing rate and activity (/0.38 * 0.67) and for oral absorption of 50% and inhalation absorption of 100%. Correction of the starting point is not required for dermal exposure as oral and dermal absorption are assumed to be comparable. Correction of the starting point is not required for oral exposure

The substance is corrosive, however quantitative endpoints are not available and local dermal and inhalation DNELs are not derived. Inhalation and dermal exposure to high concentrations of the substance (sufficient to cause local effects) should be avoided.