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EC number: 272-047-7 | CAS number: 68650-79-3
- 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
Endpoint summary
Administrative data
Description of key information
In a 28-day repeated dose oral toxicity study conducted according to the OECD Guideline 407 and in compliance with GLP, the No Observed Adverse Effect Level (NOAEL) of N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was considered to be 150 mg/kg bw/day in rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Klimisch 1
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a 28-day repeated dose oral toxicity study conducted according to the OECD Guideline 407 and in compliance with GLP, N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was administered daily to groups of Wistar rats (5/sex/dose) at doses of 0 (vehicle), 10, 50 and 150 mg/kg bw/day over a period of 28 days by gavage. Examinations during the study included: mortality, clinical signs, functional observation battery (including motor activity), body weight change, food and water consumption, ophthalmological examinations, hematology, blood chemistry, urinalysis, organ weights, macroscopic examination and histopathology.
No deaths occurred during the study and only slight signs of toxicity were observed at 150 mg/kg bw/day: salivation was observed in all male and female animals on few days between Day 11 and 28, and respiration sounds were observed after treatment in 3 male animals and 4 female animals on several days between Day 7 and 28. These findings were assessed as adverse and related to the test article in the study report. However, it is considered by expert judgement that these sporadic and transient effects are not adverse and probably due to an unpleasant taste of the substance as often observed with chemical compounds. This hypothesis is also considered by the authors of the report of the OECD 421 study (Reproduction/Developmental toxicity screening test) in which same findings are observed without increased incidence or frequency at dose-levels up to 200 mg/kg/day. No significant treatment-related changes were noted in the body weight gain, food and water consumption, ophthalmological examinations, hematological parameters, urinalysis and neurotoxicological parameters at any dose-level. No treatment-related effects were noted on organ weights or necropsy and microscopic findings.
Under the test conditions, the No Observed Adverse Effect Level (NOAEL) of N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was considered to be 150 mg/kg bw/day in the male and female Wistar rats by expert judgement (stated 50 mg/kg bw/day in the study report).
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Well performed study according to OECD 407 guideline and under GLP protocol.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
No repeated dose toxicity study via inhalation is available. N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) is a liquid with a vapour pressure around 1.78 10-7 Pa at 25°C (EPI suite estimation). Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no subacute inhalation test is needed.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Exposure via inhalation is unlikely.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
The substance is corrosive for skin. Therefore, dermal route is not the preferred route for repeated dose toxicity studies.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
The substance is corrosive for skin. Therefore, dermal route is not the preferred route for repeated dose toxicity studies.
Justification for classification or non-classification
Based on the available results (Kaspers 2009) and according to the criteria laid down in EU regulation (EC) n° 1272/2008/EC (CLP) and EU directive67/548/EEC (DSD), the substance is not classified for repeated dose toxicity.
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