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EC number: 800-029-6 | CAS number: 1290049-56-7
- 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

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:
- 0.12 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):
- 6
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.705 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point cross-reading NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d (justification see section 7.5 repeated dose and document in support of cross-reading) The corrected 8 hr inhalation NOAEC for workers is NOAEL(0.4 mg/kg) * 1.76 mg/m3 = 0.705 mg/m3. No factor 2 route extrapolation from oral to inhalation is applied: Due to very low vp (< 0.0015 Pa), exposure is only possible as aerosol. 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. However, we know that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
- 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 the appropriate fact for intra-species differences for workers is 3 and not 5. 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
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
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:
- 0.017 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):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point cross-reading NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d (justification see section 7.5 repeated dose and document in support of cross-reading). At this stage no data are available on dermal absorption. Diamines and diamine ethoxylated are not expected to easily pass the skin. However, as this is not quantitatively evaluated, 100% dermal absorption 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. However, we know that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
- 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 related to the route of exposure, the applied allometric scaling already represents a worst case.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate fact for intra-species differences for workers is 3 and not 5. 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 extended studies on non-ethoxylated amines does also not indicate additional concerns to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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:
- 0.025 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):
- 14
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.35 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point cross-reading NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d (justification see section 7.5 repeated dose and document in support of cross-reading) The corrected 24 hr inhalation NOAEC for general population is NOAEL(0.4 mg/kg) * 1/1.15 mg/m3 = 0.35 mg/m3. No factor 2 route extrapolation from oral to inhalation. Due to very low vp (< 0.0015 Pa), 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. Besides, absorption is considered to be 100% both via oral and inhalation route.
- AF for dose response relationship:
- 1
- Justification:
- No specific concerns; 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. However, we know that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
- 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 the appropriate fact for intraspecies differences for general public is 5 and not 10, 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.
- 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
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.007 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):
- 56
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point cross-reading NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d (justification see section 7.5 repeated dose and document in support of cross-reading). At this stage no data are available on dermal absorption. Diamines and diamine ethoxylated are not expected to easily pass the skin. However, as this is not quantitatively evaluated, 100% dermal absorption 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. However, we know that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
- 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 related to the route of exposure, the applied allometric scaling already represents a worst case.
- AF for intraspecies differences:
- 7
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate fact for intraspecies differences for general public is 5 and not 10, 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.
- 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 extended studies on non-ethoxylated amines does also not indicate additional concerns to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.007 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):
- 56
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Not applicable as studie was performed by oral route
- AF for dose response relationship:
- 1
- Justification:
- No specific concerns; 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. However, we know that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
- 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 related to the route of exposure, the applied allometric scaling already represents a worst case.
- AF for intraspecies differences:
- 7
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate fact for intraspecies differences for general public is 5 and not 10, 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.
- 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 extended studies on non-ethoxylated amines does also not indicate additional concerns to be considered.
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:
- medium hazard (no threshold derived)
Additional information - General Population
The
uses indicated in this dossier are limited to industrial and
professional users and exposure of the general population to Tallow-diamine3EO
is
not to be expected.
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.
