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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
6.39 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:
318 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
160 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification for exposure conditions workers vs. experimental: NOAEC x 6,7m3/10m3 x 6h/8h

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.6 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
LOAEC
Value:
480 mg/m³
Modified dose descriptor starting point:
LOAEC
Value:
810 mg/m³
Explanation for the modification of the dose descriptor starting point:

Clinical signs of respiratory tract irritation reversible within 24h and a slight body weight loss 24 hours after exposure was observed in rat exposed for 4 hours to 480 mg ethyldiisopropylamine/m3 in an acute inhalation toxicity study (Nagy, 2013). This value is used as PoD to derive a DNEL for the acute/short-term systemic effects by inhalation. As this LOAEC is for a 4 hours exposure, a LOAEC of 1210 mg/m3 was extrapolated with the Haber's law (n = 3) for a 15 min exposure. After adjustment for exposure duration and ventilation rate of workers, the NAEC is 810 mg/m3 (1210 mg/m3 x 6.7m3/10m3). 

AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
3
Justification:
conversion from LOAEC to NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.4 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor:
NOAEC
Value:
30 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
The nasal irritation is not duration-related but driven but the concentration. The NOAECs for local nasal effects are consistent between the 28- and the 90-day inhalation exposure with DMEA (Van Triel 2019 and Beebe, 2021, respectively) are set at 10 ppm and used for risk assessment.
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.6 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
LOAEC
Value:
480 mg/m³
AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
3
Justification:
Conversion LOAEC to NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.22 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:
318 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
922.22 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL derivation is based on a 90-day toxicity study by inhalation administration to rats (Beede, 2021). The starting dose for DNEL calculation is a NOAEC of 318 mg/m3 (106 ppm). Considering a ventilation rate of 0.29 m3/kg for a 6-hour exposure and a default inhalation absorption of 100%, the corresponding internal NOAEL is 92.22 mg/kg bw/d. DMEA is expected to be poorly absorbed by the skin (10% of the dose), therefore the dermal NAEL derived for workers is 922.2 mg/kg bw/d. 

AF for dose response relationship:
1
Justification:
Not needed
AF for differences in duration of exposure:
2
Justification:
Default AF
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF
AF for the quality of the whole database:
1
Justification:
Not needed
AF for remaining uncertainties:
1
Justification:
Not needed
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:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.14 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):
50
Dose descriptor starting point:
NOAEC
Value:
318 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
57.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification for exposure conditions general population vs. experimental: NOAEC x 6h/24h x 5d/7d

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
additional intraspecies differences between workers and general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.2 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
NOAEC
Value:
30 mg/m³
AF for differences in duration of exposure:
1
Justification:
The nasal irritation is not duration-related but driven but the concentration. The NOAEC are consistent between the 28- and the 90-day inhalation exposure and are set at 10 ppm. The NOAEC of 10 ppm (30 mg/m") is used for risk assessment.
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
0.33 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:
NOAEC
Value:
318 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
65.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL derivation is based on a 90-day toxicity study by inhalation administration to rats with the analogue DMEA (Beebe, 2019). The starting dose for DNEL calculation is a NOAEC of 318 mg/m3 (106 ppm). Considering a ventilation rate of 0.29 m3/kg for a 6-hour exposure of rats and a default inhalation absorption of 100%, the corresponding internal NOAEL is 92.22 mg/kg bw/d. DMEA is expected to be readily absorbed by the GI tract (100% of the dose), therefore the oral NAEL derived for general populations after adjustment for exposure duration (7 days/week) is 65.8 mg/kg bw/d.


 

AF for dose response relationship:
1
Justification:
Not needed
AF for differences in duration of exposure:
2
Justification:
Default AF
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF
AF for the quality of the whole database:
1
Justification:
Not needed
AF for remaining uncertainties:
1
Justification:
Not needed
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population