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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3.6 mg/m³
DNEL related information
DNEL derivation method:
other: German MAK commission (2002)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.2 mg/m³
DNEL related information
DNEL derivation method:
other: German MAK commission (2002)
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.6 mg/m³
DNEL related information
DNEL derivation method:
other: German MAK commission (2002)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.2 mg/m³
DNEL related information
DNEL extrapolated from long term DNEL

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:
Oral
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:
922.2 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. The dermal DNEL for systemic effect is derived from this value applying the safety factors of 2,5x4 for interspcies and 5 for intraspecies and 2 for exposure duration which lead to a value of 9,22 mg/kg/day.

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):
2.5
Justification:
Default AF
AF for other interspecies differences:
4
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:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.32 mg/m³
DNEL related information
DNEL derivation method:
other: Derivation from MAK value
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.32 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 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
Dose descriptor starting point:
NOAEC
Value:
318 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
658 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting dose for DNEL calculation is a NOAEC of 318 mg/m3 (106 ppm) from the 90 days inhalation study performed with the analogue DMEA. 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 poorly absorbed by the skin (10% of the dose), therefore the dermal NAEL derived for general populations after adjustment for exposure duration (7 days/week) is 658 mg/kg bw/d. The safety factor applied to this value are  (10 for interspecies differences, 10 for interspecies differences and 2 for exposure duration), the resulted DNEL is 3,3 mg/kg/day

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
2.5
AF for other interspecies differences:
4
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

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

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
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