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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.123 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):
25
Dose descriptor starting point:
NOAEL
Value:
2.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
3.08 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator). Starting point NOAEL 90-day on Tallow dipropylenetriamine: 2.5 mg/kgbw/d; The corrected 8 hr inhalation NOAEC for workers is NOAEL(2.5 mg/kg) * 1.76 mg/m3 = 4.4 mg/m3. A correction for exposure condition for 7 d/wk to 5 d/wk for workers has been applied. Leading to 6.17 mg/m3.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results between data.
AF for remaining uncertainties:
1
Justification:
Cross-reading to more studies on similar polyamine structures does not indicate additional concerns to be considered.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35 µg/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:
NOAEL
Value:
2.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
3.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator). 
Starting point is the NOAEL from 90-day study on Tallow dipropylenetriamine: 2.5 mg/kgbw/d At this stage no data are available on dermal absorption. Polyamines are not expected to easily pass the skin in view of its ionised form at physiological conditions. However, as this is not quantitatively evaluated, 100% dermal absorption (i.e. similar as oral) is considered as worst case assumption. A correction for exposure condition for 7 d/wk to 5 d/wk for workers has been applied.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results.
AF for remaining uncertainties:
1
Justification:
Cross-reading to more studies on similar polyamine structures does not indicate additional concerns to be considered.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.8 µg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
2.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1.09 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)
Starting point is NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d; The corrected 24 hr inhalation NOAEC for general population is NOAEL(2.5 mg/kg) * 1/1.15 mg/m3 = 2.17 mg/m3. An additional factor 2 has been applied for the route-to-route extrapolation from oral to inhalation.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
Cross-reading to more studies on similar polyamine structures does not indicate additional concerns to be considered.
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:
DNEL (Derived No Effect Level)
Value:
12.5 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
2.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results.
AF for remaining uncertainties:
1
Justification:
Cross-reading to more studies on similar polyamine structures does not indicate additional concerns to be considered.
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:
12.5 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
2.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results.
AF for remaining uncertainties:
1
Justification:
Cross-reading to more studies on similar polyamine structures does not indicate additional concerns to be considered.
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

These substances are only applied in professional or industrial setting in asphalt applications applying adequate PPE. Use results to the inclusion into or onto a matrix. Consumers/general population will not be exposed.
However, to allow for evaluation from indirect exposures via the environment, DNELs have been derived for systemic toxicity from long term exposures via all routes.

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