Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.64 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):
75
Dose descriptor starting point:
LOAEC
Value:
96 mg/m³
Modified dose descriptor starting point:
LOAEC
Value:
48 mg/m³
Explanation for the modification of the dose descriptor starting point:

Experimental conditions: 6h/day, 5 days/ week

Workplace conditions: 8h/day, 5 days / week, light activity

corrected LOAEC = LOAEC * 6/8 *6.7/10

AF for dose response relationship:
3
Justification:
LOAEC to NOAEC (already only minimal changes observed at LOAEC)
AF for differences in duration of exposure:
2
Justification:
subchronic => chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
5
Justification:
default factor
AF for the quality of the whole database:
1
Justification:
detailed study report according to NTP guidelines
AF for remaining uncertainties:
1
Justification:
none
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.6 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Value:
48 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC used
AF for differences in duration of exposure:
1
Justification:
Only a slight increase in incidences from 90 days to 2 years with no increase in severity at 96 mg/m³ (no data are available after 2 year exposure to 48mg/m³). Effects mainly concentration dependent.
AF for interspecies differences (allometric scaling):
1
Justification:
not required
AF for other interspecies differences:
1
Justification:
Local effects are due to the strong alkalinity of the substance. Since effects are exclusively seen at level II of nasal cavity, differences in airflow patterns, and clearance rates between rats and humans are not considered relevant.
AF for intraspecies differences:
5
Justification:
default factor
AF for the quality of the whole database:
1
Justification:
detailed study report according to NTP guidelines
AF for remaining uncertainties:
1
Justification:
none
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: The DNEL for effects after short-term inhalative exposure was assessed using the long-term OEL of 15 mg/m3 with an exceeding factor of two as recommended by the German Federal Institute for Occupational Safety and Health (BAuA/TRGS 900).
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:
0.1 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):
300
Dose descriptor starting point:
LOAEC
Value:
96 mg/m³
Modified dose descriptor starting point:
LOAEL
Value:
27 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Experimental conditions: 6h/day, 5 days/ week

Workplace conditions: 8h/day, 5 days / week

sRV rat (8h) = 0.38m³/kg bw

No differences in absorption expected (rat inhalation => rat oral OR rat oral => human oral)

corrected LOAEC = LOAEC * 6/8 * 0.38 m³/kg bw

AF for dose response relationship:
3
Justification:
LOAEC to NOAEC (already only minimal changes observed at LOAEC)
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default rat => human
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
detailed study report according to NTP guidelines
AF for remaining uncertainties:
1
Justification:
none
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:
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:
DNEL (Derived No Effect Level)
Value:
0.05 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):
600
Dose descriptor starting point:
other: original value: LOAEC = 96 mg/m³ (unit not available in picklist)
Value:
96 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
27 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Experimental conditions: 6h/day, 5 days/ week

Consumer conditions: 24h/day, 5 days / week

sRV rat (24h) = 1.15m³/kg bw

No differences in absorption expected (rat inhalation => rat oral OR rat oral => human oral)

corrected LOAEC = LOAEC * 6/24 * 1.15 m³/kg bw

AF for dose response relationship:
3
Justification:
LOAEC to NOAEC (already only minimal changes observed at LOAEC)
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default rat => human
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
detailed study report according to NTP guidelines
AF for remaining uncertainties:
1
Justification:
none
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

Since diethylamine is used at industrial domains only, no exposure of the general population to diethylamine is expected. Therefore no DNELs for the general population were calculated.