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EC number: 701-349-8 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 July 2017 - 15 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty Acids, C14 and C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C34H68N2O3
- IUPAC Name:
- Fatty Acids, C14 and C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C15 and C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C35H70N2O3
- IUPAC Name:
- Fatty Acids, C15 and C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C36H72N2O3
- IUPAC Name:
- Fatty Acids, C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C15 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C37H74N2O3
- IUPAC Name:
- Fatty Acids, C15 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C16 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C38H76N2O3
- IUPAC Name:
- Fatty Acids, C16 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C17 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C39H78N2O3
- IUPAC Name:
- Fatty Acids, C17 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C40H80N2O3
- IUPAC Name:
- Fatty Acids, C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Stearic acid
- EC Number:
- 200-313-4
- EC Name:
- Stearic acid
- Cas Number:
- 57-11-4
- Molecular formula:
- C18H36O2
- IUPAC Name:
- stearic acid
- Reference substance name:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- Molecular formula:
- C16H32O2
- IUPAC Name:
- palmitic acid
- Reference substance name:
- Myristic acid
- EC Number:
- 208-875-2
- EC Name:
- Myristic acid
- Cas Number:
- 544-63-8
- Molecular formula:
- C14H28O2
- IUPAC Name:
- myristic acid
- Reference substance name:
- 2-(2-aminoethylamino)ethanol
- EC Number:
- 203-867-5
- EC Name:
- 2-(2-aminoethylamino)ethanol
- Cas Number:
- 111-41-1
- Molecular formula:
- C4H12N2O
- IUPAC Name:
- 2-(2-aminoethylamino)ethanol
- Test material form:
- solid
- Details on test material:
- Identification: N-(2-{[C16-18 (EVEN NUMBERED) ALKANOYL]AMINO}ETHYL)-N-(2-HYDROXYETHYL)[C16-18 (EVEN NUMBERED) ALKYLAMIDE
Storage Conditions: Room temperature
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: n/a
- Specific activity: n/a
- Locations of the label: n/a
- Expiration date of radiochemical substance: n/a
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: n/a
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: n/a
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: applied undiluted
- Final preparation of a solid: n/a
FORM AS APPLIED IN THE TEST (if different from that of starting material): applied as supplied
OTHER SPECIFICS: n/a
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: body weight variation did not exceed ±20% of the mean body weight at the start of treatment
- Fasting period before study: yes
- Housing: housed in groups of up to 4 individuals in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): free access to food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK)
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): minimum of 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 : 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- The test item was ground to a fine powder using a mortar and pestle and freshly prepared, as required, as a suspension in 5% Carboxymethylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5% Carboxymethylcellulose
- Amount of vehicle (if gavage): 5%
- Justification for choice of vehicle: the most suitable vehicle
- Lot/batch no. (if required): not specified
- Purity: not specified
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: maximum guideline required concentration - 2000 mg/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Each animal was givena single dose of 10 mL/kg dose volume of 2000 mg/kg of the test item of 200 mg/mL concentration.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2 and 4 hours after dosing then daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight - Statistics:
- not required
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths reported
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
Table 2: Number of animals dead (and with evident toxicity)
Dose (mg/kg bw) |
Mortality (# dead / total) |
Time range of deaths (hours) |
Number with evident toxicity (# / total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2000 |
- |
0 / 5 |
0 / 5 |
n/a |
- |
0 / 5 |
0 / 5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System Unclassified).
- Executive summary:
OECD 420 (2018) - In an acute oral toxicity study, a group of fasted, 8-12 week old female Wistar rats were given a single oral dose of
N-(2-{[C16-18 (even numbered) alkanoyl]amino}ethyl)-N-(2-hydroxyethyl)[C16-18 (even numbered) alkylamide
at a single dose rate of 2000 mg/kg bw (limit test) and observed for 14 days.In the absence of mortality during the observation period, the oral LD50 was estimated to be greater than 2000 mg/kg bw.
In addition, there were no treatment related clinical signs, necropsy findings or changes in body weight observed in any of the individuals.
In conclusion, the test item,
N-(2-{[C16-18 (even numbered) alkanoyl]amino}ethyl)-N-(2-hydroxyethyl)[C16-18 (even numbered) alkylamide
did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixture.
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