Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.44 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):
10
Dose descriptor starting point:
NOAEL
Value:
2.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
4.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

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. No factor 2 route extrapolation from oral to inhalation. Due to very low vp (less than 4.7 x 10-5 Pa at 20°C), exposure is only possible as aerosol or larger particles. If any inhalation does occur, this can only be in the form of larger droplets, as the use does not include fine spraying. Droplets will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This results to no principal difference in absorption compared oral route.

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL, effects at LOAEL are not severe and of local nature.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
1
Justification:
ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 has been applied. As effects are interpreted as being local and related to the route of exposure (see comments), the already applied allometric scaling already represents a worst case.
AF for intraspecies differences:
5
Justification:
ECETOC reported in 2010 after an extensive scientific review that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intra-species variability, which includes the remaining differences factor of 2.5 for interspecies. This factor may be increased by modified factors as suggested by the German Auschuss für Gefahrstoffe. In this case the factor 5 is used for workers to accommodate for the possible high uncertainty between individuals as the effects for which the risk assessment is made possibly includes a local response.
As the effects for which the risk assessment is made is based on a local response following an non-specific mechanism with expected inherently relative low variation between individuals, no additional factor is needed to accommodate for possible high uncertainty between individuals on the basis of possible specific sensitivities.
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results within category. Furthermore, within the category of Polyamines, the cross-reading to the more toxic Tallow dipropylenetriamine represents a conservative approach for Tallow tripropylenetetraamine.
AF for remaining uncertainties:
1
Justification:
The applied cross-reading to Tallow dipropylenetriamine reporesents a conservative appraoch for Tallow tripropyleneteramine as tetramines show a somewhat lower toxicity. 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 (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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):
40
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:

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.

AF for dose response relationship:
1
Justification:
No specific concerns. Effects at LOAEL are not severe and probably only of local nature.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for allometric scaling from rat to human.
AF for other interspecies differences:
1
Justification:
ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 has been applied. As effects are interpreted as being local and related to the route of exposure (see comments), the already applied allometric scaling already represents a worst case.
AF for intraspecies differences:
5
Justification:
ECETOC reported in 2010 after an extensive scientific review that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intra-species variability, which includes the remaining differences factor of 2.5 for interspecies. This factor may be increased by modified factors as suggested by the German Auschuss für Gefahrstoffe. In this case the factor 5 is used for workers to accommodate for the possible high uncertainty between individuals as the effects for which the risk assessment is made possibly includes a local response.
As the effects for which the risk assessment is made is based on a local response following an non-specific mechanism with expected inherently relative low variation between individuals, no additional factor is needed to accommodate for possible high uncertainty between individuals on the basis of possible specific sensitivities.
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results within category. Furthermore, within the category of Polyamines, the cross-reading to the more toxic Tallow dipropylenetriamine represents a conservative approach for Tallow tripropylenetetraamine.
AF for remaining uncertainties:
1
Justification:
The applied cross-reading to Tallow dipropylenetriamine reporesents a conservative appraoch for Tallow tripropyleneteramine as tetramines show a somewhat lower toxicity. 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:
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:
no hazard identified
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. The substance is not used in the consumer sector and consumers/general population will not be exposed. Assessment of indirect exposure is not needed as the tonnage is not above 1000 tpa, and the substance not is classified as CMR or toxic (R48 or STOT-RE 1).