Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 249-276-6 | CAS number: 28872-01-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.73 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA guidance, with ECETOC recommendations
- Overall assessment factor (AF):
- 6
- Dose descriptor starting point:
- LOAEL
- Value:
- 2.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.44 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:
- 3
- 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. 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.
- 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:
- 0.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA guidance, with ECETOC recommendations
- Overall assessment factor (AF):
- 24
- 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:
- 3
- 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. 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.
- 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:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The starting point dose descriptor for systemic toxicity by Oleyl dipropylene triamine is based on cross-reading from data on Tallow (C16-18, C18-unsaturated) dipropylenetriamine.
Structurally, the two linear-alkyl dipropylene triamines Oleyl dipropylene triamine and Tallow (C16-18, C18-unsaturated) dipropylenetriamine are very similar: a linear alkyl chain and a primary amine at the end, with 2 secondary amines in between separated by a propyl group. Consequently, they share the same chemical reactivity and their physico-chemical properties are very similar from which a comparable toxicological profile can be expected.
Within a specific chemical structure, the variability of the alkyl chain length is considered to have a possible modifying activity, which is related to modification of the physiological properties of the molecule by the increase or shortening of the apolar alkyl chain part. This is suspected to influence aspects related to bioavailability, but not aspects of chemical reactivity and metabolism pathways, aspects that could have an impact on specific mechanisms of toxicity.
The ratio between the C16, C18 and C18:1 (C18-unsaturated) alkyl chains in the Oleyl and Tallow dipropylene triamine products show an overlap in alkyl chain of about 50%:
- Oleyl: C18:1 = 85.5%; C18 = 12.4 %; C16: 7,1%
- Tallow: C18:1 = 26.5%; C18 = 38.3 %; C16: 35.2%
The higher level of unsaturation in Oleyl based products has never shown to have an important effect. This is in agreement with the expectation that these structure do not undergo an important level of metabolism. and metabolism occurs on the limited absorbed material, the resulting alkyl chains will fit in the physiological pool of these natural alkyl chains. Further, the relatively somewhat sorter chain lengths of C16 would make it slightly more bioavailable, in agreement to the notion that shorter alkyl chains represent a more conservative evaluation.
Consequently, the data on Tallow (C16-18, C18-unsaturated-alkyl) dipropylene triamine can be used for the read-across to Oleyl dipropylene triamine.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.16 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA guidance, with ECETOC recommendations
- Overall assessment factor (AF):
- 14
- Dose descriptor starting point:
- NOAEL
- Value:
- 2.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2.17 mg/m³
- 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; The corrected 24 hr inhalation NOAEC for general population is NOAEL(2.5 mg/kg) * 1/1.15 mg/m3 = 2.17 mg/m3. No factor 2 route extrapolation from oral to inhalation. Due to very low vp (< 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:
- 7
- 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 7 is used 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.
- 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:
- 0.04 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA guidance, with ECETOC recommendations
- Overall assessment factor (AF):
- 56
- 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:
- 7
- 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 7 is used 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.
- 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:
- 0.04 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA guidance, with ECETOC recommendations
- Overall assessment factor (AF):
- 56
- 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:
No route-to-route extrapolation is needed.
- 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:
- 7
- 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 7 is used 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.
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)