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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- This 14 d study, intended to be a dose-ranging study to identify doses to be used in a subsequent 90 d study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Principles of method if other than guideline:
- duration: 14 d
- GLP compliance:
- yes
- Limit test:
- no
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:
- male/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:
- other: water with Tween 80 (0.5 % w/v) and carboxymethyl cellulose (1 % w/v)
- Details on oral exposure:
- Preliminary tests found that the test substance was suitable for oral gavage by suspension in water with Tween 80 (0.5 % w/v) as a surfactant and carboxymethyl cellulose (1 % w/v) as a suspending agent.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analyses performed to verify the concentrations of the test substance in dosing formulations in the 90-day study showed that they were within an acceptable range compared to their respective nominal concentrations.
- Duration of treatment / exposure:
- 14 d
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- five of each sex
- Control animals:
- yes
- Details on study design:
- The following observations and examinations were performed: mortality and clinical signs – daily, body weight and food consumption – weekly. Additionally samples for hematology and clinical chemistry analysis were taken just prior to sacrifice, and gross necropsy was performed, recording any gross pathological observations and organ weights.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the NOEL from this study was >1000 mg/kg bw/day.
- Executive summary:
A study was conducted to determine repeated dose toxicity of the test substance according to a design based on OECD Guideline 407. This 14 d study intended to identify the dose-range to be used in a subsequent 90 d study. Preliminary tests found that the test substance was suitable for oral gavage by suspension in water with Tween 80 (0.5% w/v) as a surfactant and carboxymethyl cellulose (1% w/v) as a suspending agent. Ten Sprague-Dawley rats, five of each sex, were dosed with a vehicle control and with the test substance at 100, 300, and 1000 mg/kg bw/day daily through duration of the study. Observations for mortality and clinical signs were made daily and of body weight and food consumption weekly. Additionally samples for hematology and clinical chemistry analysis were taken just prior to sacrifice, and gross pathology was performed. Analyses performed to verify the concentrations of the test substance in dosing formulations in the 90-day study showed that they were within an acceptable range compared to their respective nominal concentrations. No incidence of clinical signs or death was found following 14 days of treatment with the test substance at 0, 100, 300, or 1000 mg/kg bw/day. Furthermore, no adverse effects were observed on body weight gain, food consumption, hematological parameters, clinical chemistry, gross pathology, or on absolute or relative organ weights. Under the study conditions, the NOEL from this study was >1000 mg/kg bw/day (Nestmann, 2017).
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