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EC number: 298-680-9 | CAS number: 93820-97-4
- 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:
- 23 Sep - 08 Dec 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted Dec 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Docosyl stearate
- EC Number:
- 244-971-0
- EC Name:
- Docosyl stearate
- Cas Number:
- 22413-03-2
- Molecular formula:
- C40H80O2
- IUPAC Name:
- docosyl octadecanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- SPF [Crl:CD(SD)]
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Atsugi Breeding Center, Charles River Laboratories Japan Inc, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: 197 - 203 g (range)
- Fasting period before study: Yes, approximately 18 h overnight
- Housing: 2 or 3 animals per cage were housed in plastic solid-floored cages (W 440 x D 275 x H 180 mm; by Hanyu Seimitsu Inc.) with bedding (ALPHA-dri, Shepherd Specialty Papers, Inc., Lot Nos: 04116 and 05116).
- Diet: CR -LPF pelleted diet (irradiation-sterilized, Oriental Yeast Co., Ltd., Lot No.: 160621), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: Animals were quarantined/acclimated to the test environment for over a week at the testing facility.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24
- Humidity (%): 39 - 48
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23 Sep 2016 To: 08 Dec 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Since the acute oral toxicity of the test substance was expected to be low, the starting dose level was set at 2000 mg/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 (first and second step, respectively)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed frequently for the first 6 hours after administration (from immediately after administration to 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after administration), and once daily thereafter for 14 days, for clinical signs such as abnormalities of external appearance, nutritional condition, posture, behavior and excretions. Body weight was recorded on day 0 of administration and on days 1, 3, 7 and 14 after administration.
- Necropsy of survivors performed: Yes, all animals were sacrificed after the 14-day observation period by exsanguination via the abdominal aorta under isoflurane anesthesia and necropsied. External appearance and organs/tissues in the cranial, thoracic and abdominal cavities were examined macroscopically. - Statistics:
- For body weight, the mean value with standard deviation was calculated for each point measured for each dose step. The body weight gain during the observation period from day 0 of administration to day 14 after administration was determined and the mean value with standard deviation was calculated in the same manner.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
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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