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EC number: 271-547-2 | CAS number: 68585-02-4
- 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:
- 2016-09-27 to 2016-10-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted December 17, 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine
- EC Number:
- 271-547-2
- EC Name:
- Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine
- Cas Number:
- 68585-02-4
- Molecular formula:
- C28H63N5O4
- IUPAC Name:
- acetic acid;N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine;octadecanoic acid
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 168 - 183 g
- Fasting period before study: yes, feeding was discontinued approx. 16 hours before administration
- Housing: MAKROLON cages (type III plus) groups of 3 animals
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 ad libitum
- Water (e.g. ad libitum): from municipal source, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): no information available
- Photoperiod (hrs dark / hrs light): 12 h dark/light cycle
First dosing October 11, 2016
Termination of the in-life phase October 26, 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Sesame oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg bw - limit test - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Initial test three females at 2000 mg/kg bw, as no animal died further 3 females were exposed.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily animals were observed, weighting weekly
- Necropsy of survivors performed: yes - Statistics:
- not applicable - limit test
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No animal died
- Clinical signs:
- Slightly reduced motility, slight ataxia, slightly reduced muscle tone, and pilo-erection in all 6 of 6 animals and slight dyspnoea in 2 of 6 animals 5 to 30 minutes after administration.
- Body weight:
- All animals gained the expected body weight.
- Gross pathology:
- No pathological changes were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 > 2000 mg/kg bw
- Executive summary:
In an acute oral toxicity study according to OECD guideline 423 and EC method B.1 tis, a total of 6 female CD rats were given a single oral dose of 2000 mg/kg bw Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine and observed for 14 days.
Oral LD50 Females = > 2000 mg/kg bw
No animal died prematurely. The following clinical signs were observed: slightly reduced motility, slight ataxia, slightly reduced muscle tone, and pilo-erection in all 6 of 6 animals and slight dyspnoea in 2 of 6 animals 5 to 30 minutes after administration. All animals gained theexpected body weight. No pathological changes were observed at necropsy.
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