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EC number: 221-304-1 | CAS number: 3061-75-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-conducted GLP study. COA is not included in the report but has been provided separately. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- (Z)-docos-13-enamide
- EC Number:
- 204-009-2
- EC Name:
- (Z)-docos-13-enamide
- Cas Number:
- 112-84-5
- Molecular formula:
- C22H43NO
- IUPAC Name:
- docos-13-enamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Sponsor's identification: ERUCAMIDE
Description: off-white powder
Batch number: 100054
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals were randomly allocated to cages. Females were nulliparous and non-pregnant. After an acclimation period of at least five days, animals were selected at random and assigned a number unique within the study. Animals were housed in groups of three by sex in solid-floor polypropylene cages with wood flakes. Except for the overnight fast immediately before dosing and for approximately three to four hours after dosing, food and tap water were available ad lib. Temperature was controlled to 19-25 °C; relative humidity was controlled to 30-70%. Rate of air exchange was at least fifteen changes per hour. Lighting was controlled to give 12 hours continuous light and 12 hours continuous darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- Test material was freshly prepared as required as a suspenion in arachis oil BP. Animals were dosed once only with a dose volume of 10 ml/kg bw by gavage using a metal cannula attached to a graduated syringe. The individual volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing.
- Doses:
- 2000 mg/kg bw as suspension in peanut oil
- No. of animals per sex per dose:
- Three
- Control animals:
- no
- Details on study design:
- Animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment. At the end of the observation period, animals were killed by cervical dislocation. All animals were subjected to gross pathological examination.
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: According to guideline, estimated LD50 is greater than 2500 mg/kg based on no mortality at 2000 mg/kg in either sex.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study.
- Body weight:
- other body weight observations
- Remarks:
- All animals showed expected gains in bodyweight over the study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
No mortalities or signs of systemic toxicity were observed during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
- Executive summary:
This study was performed to assess the acute oral toxicity of erucamide following single oral administration to the Sprague-Dawley rat. The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy examination. There were no deaths. There were no signs of toxicity. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley rat was estimated as being greater than 2500 mg/kg bw. No mortalities were noted in animals treated with 2000 mg/kg bodyweight. The test material does not meet the criteria for classification according to Regulations (EC) No 1272/2008.
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