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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 254-754-2 | CAS number: 40027-38-1
- 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:
- 0.074 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:
- 0.75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.85 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The default calculator has been applied: Starting point is read-across to NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d; Based on Oleyl-diamine content in Oleyl-diamine mono-oleate of 53.5%, this equals a NOAEL of 0.75 mg/kg bw/d for Oleyl-diamine mono-oleate.
The corrected 8 hr inhalation NOAEC for workers is calculated applying the default calculation: oral NOAELrat * 1/0.38 * 6.7/10. Additionally, a correction for differences between human and experimental exposure conditions of 1.4 is added (5 d/w versus experimental daily exposure). This results to a NOAEC workers of 1.85 mg/m3.
No factor 2 route extrapolation from oral to inhalation is applied: Oleyl-diamine mono-oleate is a paste with a very low vapour pressure of ≤ 0.00087 Pa at 25 °C. Exposure by inhalation would only be possible in the form of aerosol, consisting of larger droplets depositing in upper airways. Aerosols will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This result to no principal difference in absorption compared to oral route.
- AF for dose response relationship:
- 1
- Justification:
- No specific concerns; starting point is NOAEL, effects at LOAEL are not severe and probably 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:
- 2.5
- Justification:
- ECHA default.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default.
- 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 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:
- 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:
- 0.01 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1.05 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The default calculator has been applied: Starting point is read-across to the NOAEL from 90-day study on C12-14-Diamine: 0.4 mg/kgbw/d. Based on Oleyl-diamine content in Oleyl-diamine mono-oleate of 53.5%, this equals a NOAEL of 0.75 mg/kg bw/d for Oleyl-diamine mono-oleate.
At this stage no data are available on dermal absorption. Diamines 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 is considered as worst-case assumption. Additionally a correction for differences between human and experimental exposure conditions of 1.4 is added (5 d/w versus experimental daily exposure): 8hr-NOAEL workers = NOAEL(0.75 mg/kg) * 1.4 = 1.05 mg/kg bw/d.
- 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:
- 2.5
- Justification:
- ECHA default.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default.
- 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 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:
- 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
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
Oleyl-diamine mono-oleateis not used in the consumer sector.
Also 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 STOT-RE Cat.1.
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.
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