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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 251-846-4 | CAS number: 34140-91-5
- 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:
- 98.4 µg/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:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2.46 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point is the NOAEL for Oleyl-diamine in Oleyl-diamine dioleate (see documents supporting the read-across) which is based upon cross-reading from the 90-day study on C12-14-Diamine resulting to a NOAEL of 0.4 mg/kgbw/d. The NOAEL of 0.4 mg/kgbw/d for C12-14-diamine is based on effects observed of foamy macrophages seen at higher dose levels of 1.5 and 6 mg/kg. The effects are comparable and evaluated similar as in all other studies involving primary amine structures, and are considered to be of a non-adverse and local nature. This NOAEL therefore represents a very conservative level. Furthermore, the NOAEL is not really influenced by the duration of the study, which supports the lack of bio-accumulating potential of the diamines. Despite this, and the results from a 28-day study on Oleyl diamine and Oleyl diamine dioleate showing a NOAEL of 1.25 and 5 mg/kg/day, respectively, the NOAEL from the 28 and 90-day study with C12/14-diamine of 0.4 mg/kg/day is taken as conservative value.
This is then converted to the corresponding value for the dioleate salt of Oleyl-diamine, resulting to a derived oral NOAEL for Oleyl-diamine dioleate of about 1 mg/kg bw/day. (mw oleyl-diamine = 324.7, mw oleyl-diamine dioleate = 889.5; 0.4 x 889.5/324.7 = 1.1)
The corrected 8 hr inhalation NOAEC for workers is NOAEL (1) * 1.76 *1.4 mg/m3 = 2.46 mg/m3.
- 1.76 : correction for differences in respiratory volume (workers)
- 1.4 : correction for differences between human and experimental exposure condition (workers)
- The use of the factor 2 for route extrapolation from oral to inhalation would represent a conservative approach. Due to very low vp, 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:
- Default (DNEL calculator). No specific concerns; starting point is NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator). Default assessment factor for sub-chronic to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator). Already included in NOAEC calculation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator). Default assessment factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator). Assessment factor of 5 for workers recommended by Reach guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator). Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- Cross-reading to more studies on similar amine 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 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:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point is the NOAEL for Oleyl-diamine in Oleyl-diamine dioleate (see discussion) which is based upon cross-reading from the 90-day study on C12-14-Diamine resulting to a NOAEL of 0.4 mg/kgbw/d. This is then converted to the corresponding value for the dioleate salt of Oleyl-diamine, resulting to a derived oral NOAEL for Oleyl-diamine dioleate of about 1 mg/kg bw/day. (mw oleyl-diamine = 324.7, mw oleyl-diamine dioleate = 889.5; 0.4 x 889.5/324.7 = 1.1) At this stage no data are available on dermal absorption. As this is not quantitatively evaluated, 100% dermal absorption is considered as worst case assumption.
The corrected dermal NOAEL for workers is NOAEL (1) * 1.4 = 1.4 mg/kg bw/day.
- 1.4 : correction for differences between human and experimental exposure condition (workers)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL Calculator); No specific concerns; starting point is NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator). Default assessment factor for sub-chronic to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator). Default assessment factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator). Assessment factor of 5 for workers recommended by Reach guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator). Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- Cross-reading to more studies on similar amine 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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:
- 17.4 µg/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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.4 mg/kg bw/day
- Value:
- 0.87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point is the NOAEL for Oleyl-diamine in Oleyl-diamine dioleate (see documents supporting the read-across) which is based upon cross-reading from the 90-day study on C12-14-Diamine resulting to a NOAEL of 0.4 mg/kgbw/d. The NOAEL of 0.4 mg/kgbw/d for C12-14-diamine is based on effects observed of foamy macrophages seen at higher dose levels of 1.5 and 6 mg/kg. The effects are comparable and evaluated similar as in all other studies involving primary amine structures, and are considered to be of a non-adverse and local nature. This NOAEL therefore represents a very conservative level. Furthermore, the NOAEL is not really influenced by the duration of the study, which supports the lack of bio-accumulating potential of the diamines. Despite this, and the results from a 28-day study on Oleyl diamine and Oleyl diamine dioleate showing a NOAEL of 1.25 and 5 mg/kg/day, respectively, the NOAEL from the 28 and 90-day study with C12/14-diamine of 0.4 mg/kg/day is taken as conservative value.
This is then converted to the corresponding value for the dioleate salt of Oleyl-diamine, resulting to a derived oral NOAEL for Oleyl-diamine dioleate of about 1 mg/kg bw/day. (mw oleyl-diamine = 324.7, mw oleyl-diamine dioleate = 889.5; 0.4 x 889.5/324.7 = 1.1)
The corrected 8 hr inhalation NOAEC for General population is NOAEL (1) * 1/1.15 mg/m3 = 0.87 mg/m3.
- 1.15 : correction for differences in respiratory volume (General Population)
- The use of the factor 2 for route extrapolation from oral to inhalation would represent a conservative approach. Due to very low vp, 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:
- Default (DNEL calculator). No specific concerns; starting point is NOAEL and the highest dose-level tested.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator). Default assessment factor for sub-chronic to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator). Already included in NOAEC calculation;
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator). Default assessment factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator). Assessment factor of 10 for General Population recommended by Reach guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator). Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- Cross-reading to more studies on similar amine 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Value:
- 1 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point is the NOAEL for Oleyl-diamine in Oleyl-diamine dioleate (see discussion) which is based upon cross-reading from the 90-day study on C12-14-Diamine resulting to a NOAEL of 0.4 mg/kgbw/d. This is then converted to the corresponding value for the dioleate salt of Oleyl-diamine, resulting to a derived oral NOAEL for Oleyl-diamine dioleate of about 1 mg/kg bw/day. (mw oleyl-diamine = 324.7, mw oleyl-diamine dioleate = 889.5; 0.4 x 889.5/324.7 = 1.1) At this stage no data are available on dermal absorption. As this is not quantitatively evaluated, 100% dermal absorption is considered as worst case assumption.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator). No specific concerns; starting point is NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator). Default assessment factor for sub-chronic to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator). Default assessment factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator). Assessment factor of 10 for General Population recommended by Reach guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator). Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- Cross-reading to more studies on similar amine 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Value:
- 1 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point is the NOAEL for Oleyl-diamine in Oleyl-diamine dioleate (see documents supporting the read-across) which is based upon cross-reading from the 90-day study on C12-14-Diamine resulting to a NOAEL of 0.4 mg/kgbw/d. This is then converted to the corresponding value for the dioleate salt of Oleyl-diamine, resulting to a derived oral NOAEL for Oleyl-diamine dioleate of about 1 mg/kg bw/day. (mw oleyl-diamine = 324.7, mw oleyl-diamine dioleate = 889.5; 0.4 x 889.5/324.7 = 1.1) At this stage no data are available on oral absorption. Oleyl-diamine is not expected to easily pass the intestinal wall from the dioleate salt form, however, as this is not quantitatively evaluated, 100% oral absorption is considered as worst case assumption.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator). No specific concerns; starting point is NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator). Default assessment factor for sub-chronic to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator). Already included in NOAEC calculation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator). Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator). Assessment factor of 10 for General Population recommended by Reach guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator). Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- Cross-reading to more studies on similar amine structures does 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:
- low hazard (no threshold derived)
Additional information - General Population
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.