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Diss Factsheets
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EC number: 947-890-5 | 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:
- From January 23, 2018 to February 9, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- (9Z)-N-(2-hydroxyethyl)octadec-9-enamide; (9Z,12Z)-N-(2-hydroxyethyl)octadeca-9,12-dienamide
- Molecular formula:
- No molecular formula available for this UVCB.
- IUPAC Name:
- (9Z)-N-(2-hydroxyethyl)octadec-9-enamide; (9Z,12Z)-N-(2-hydroxyethyl)octadeca-9,12-dienamide
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female rates were selected for the test because they are frequently more sensitive to the toxicity of test compound than males. The rats were housed individually in stainless steel cages in a temperature 66-77oF, humidity 30-70% and light controlled 12 hr/cycle room. Each animal were assigned test number which appeared on a cage card visible on the front of each cage. The rats were maintained according to the recommendations contained in National academy press 2011: "Guide for care and use of Laboratory animals". Purina Laboratory Rat Chow and water were available ad libitum. The rats were acclimated at least five days prior to treatment.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- All test animals were fasted overnight prior to dosing. The test substance, was warmed in a water bath prior to dosing and administered orally as an amber coloured liquid to fasted animals according to individual body weights. Dosage volumes were administered via a metal dosing cannula.
- Doses:
- An initial limit dose of 5000mg/kg was administered to one rat. Due to the absence of mortality in this rat, 2 additional rats received the same dose level; simultaneously. There were mortality in one of the 2 additional animals. Two more animals were dosed at the 5000mg/kg level to fulfil the study requirement. There was no mortality observed in the additional 2 animals.
- No. of animals per sex per dose:
- 5 animals
- Control animals:
- no
- Details on study design:
- A limit test is planned for the study. One rat was dosed at 5000mg/kg, if the rat dies the main test will be conducted starting at an appropriate dose level (usually 175mg/kg) to determine LD50. If the rat survives at 5000mg/kg, 2 additional rats will be dosed and if both survive the LD50 will be considered greater than the limit dose and the study will be terminated. (I.e. carried out to 14 days observation without dosing further rats). If one or both rats die. 2 additional rats will be dosed one at a time. Results will be evaluated. The LD50 is considered to be greater than 5000mg/kg if 3 or more animals survive. If the LD50 is determined to be less than 5000mg/kg, the main test is conducted.
- Statistics:
- At the end of the observation period the calculation of the LD50was conducted according to the agency’s developed software package (AOT425StatPgm).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal died out of 5 animals tested.
- Clinical signs:
- other: Staining around anal area observed for one animal.
- Gross pathology:
- Staining around anal area observed for one animal. No ghross changes observed
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Under the study conditions, the LD50 for the test substance was determined to be >5000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance, amides, C18-unsatd., N-hydroxyethyl, using the up-and-down procedure according to the OECD Guideline 425, in compliance with GLP. Five female Sprague-Dawley rats were randomly selected for an acute oral toxicity study. Fasted rats were given a single dose of the test substance warmed in a water bath prior to dosing and administered orally as an amber coloured liquid according to individual body weights. An initial limit dose of 5000 mg/kg was administered to one rat. Due to the absence of mortality in this rat, 2 additional rats received the same dose level simultaneously. There was mortality in one of the 2 additional animals. Two more animals were dosed at the 5000 mg/kg level to fulfil the study requirement. There was no mortality in the additional 2 animals. Under the study conditions, the LD50 for the test substance was determined to be >5000 mg/kg bw (Michael, 2018).
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