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Diss Factsheets
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EC number: 208-867-9 | CAS number: 544-31-0
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- To minimize the number of animals, the up and down procedure adopted by OECD (2008a) for acute toxicity testing strives to use a maximum of five animals, starting with a single dose to a single rat. After a period of observation, the dose may or may not be adjusted up or down before dosing the next animal. As the test substance is not expected to have potent toxicity, the intent of this study was to test at the maximum dose of 2000 mg/kg bw. Thus, this test is characterized as a limit test.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- Up and Down Procedure
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Palmidrol
- EC Number:
- 208-867-9
- EC Name:
- Palmidrol
- Cas Number:
- 544-31-0
- Molecular formula:
- C18H37NO2
- IUPAC Name:
- N-(2-hydroxyethyl)hexadecanamide
- Test material form:
- solid
- Remarks:
- particle size: 0.5–10 μm
- Details on test material:
- manufactured by Epitech Group Srl, Milano Italy, supplied by Prismic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Sprague-Dawley rats (Vivo Bio Tech Ltd), age: 6–7 weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- 5 females Sprague-Dawley rats were used for the study.
Observation of clinical signs: at 10, 30 min, 1, 2, and 4 h after dosing, and thereafter daily until day 15. Each animal was subjected to gross pathology.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test substance did not induce any mortality at the limit dose of 2000 mg/kg bw.
- Clinical signs:
- other: No abnormal clinical signs were noted in any of the five test animals observed at 10 and 30 min, 1, 2, and 4 h, and thereafter daily until day 15 postdosing.
- Gross pathology:
- No gross pathological abnormalities were found.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the LD50 of the test substance was >2000 mg/kg bw after single oral administration to Sprague-Dawley rats.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance in female Sprague-Dawley rats using the “Up and Down Procedure” according to OECD Guideline 425 (2008a). As the substance was not expected to have potent toxicity, it was administered at the maximum dose of 2000 mg/kg bw (limit test) to 5 female rats. The test substance did not induce any mortality or abnormal clinical signs in any of the animals observed at 10 and 30 min, 1, 2, and 4 h, and thereafter daily until Day 15 post-dosing. Each animal was subjected to gross necropsy and no gross pathological abnormalities were found. Microscopic pathology was not conducted in the absence of any gross pathological changes. Under the study conditions, the LD50 of the test substance was >2000 mg/kg bw after single oral administration to Sprague-Dawley rats (Nestmann, 2017).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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