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EC number: 272-911-3 | CAS number: 68920-03-6 A complex combination obtained by steam distillation of C16-18 and C18-unsatd. glycerides followed by condensation of the steam.
- 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:
- weight of evidence
- Study period:
- Not available
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to standard guidelines in compliance with GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- U.S. Fed. Reg., Titel 21, Dec. 22nd, 1978, part II
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
- IUPAC Name:
- Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
- Details on test material:
- Name of test material (as cited in study report): Castor oil (CAS N° 8001-79-4, EC N° 232-293-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy'
- Physical state: Slight yellow, clear oil
- pH: 6.5
- Storage condition of test material: Normal room temperature, in darkness
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfe1d
- Weight at study initiation: Male: 176.4 - 188.9 g; Female: 151.4 - 158.1 g
- Fasting period before study: Yes, 16 h before administartion of the test material
- Housing: Collective caging in macrolon type III/max. 5
- Diet: Ssniff-R Alleindiat flilr Ratten feed, ad libitum
- Water (e.g. ad libitum): Macrolon drinking bottles, Becker & Co. 4620 Castrop-Rauxel, ad libitum
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature: 20±2 °C
- Humidity: 50-80%
- Air changes (per hr):
- Photoperiod: 12 h dark/12 h light
IN-LIFE DATES: From: Feb. 19, 1988 To: March 3, 1988
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Undiluted
MAXIMUM DOSE VOLUME APPLIED: 0.95 mL (1 mL = 0.9904 g XM out of 10 weighings)
- Doses:
- 5 mL/kg
- No. of animals per sex per dose:
- 5 male/female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Clinical observations: About 20 min, 1-2 h, 3-6 h, 24/48 h, Days 3- 6 and 7-14; Body weight: At Days 0 (beginning of the experiment), 7 and 14; Necropsy: Immediately after death of animal and after sacrifice, at the end of the 14 d observation period all surviving
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, gross pathology, mortality - Statistics:
- Not reported
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Remarks on result:
- other: = 4952 mg/kg
- Mortality:
- No mortalities were observed
- Clinical signs:
- other: No clinical-toxicological symptoms observed
- Gross pathology:
- No macroscopic findings in the cranial, thoracic and abdominal cavity
- Other findings:
- Not applicable
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test substance is considered to be greater than > 5 mL/kg = 4,952 mg/kg bw.
- Executive summary:
In order to evaluate the acute oral toxicity of ‘glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy’ (as castor oil) in rats, an acute oral toxicity study was conducted. The procedure performed in this study was based on the OECD Guideline 401, 1987 and to GefStoffV, Aug. 26th, 1986, (BGBI 1470).
A group of 5 fasted male and female Wistar rats were exposed to a single oral dose of 5 mL/kg bw. Clinical signs and mortality were recorded during the 14 day observation period. Necropsy was conducted on moribund animals and those terminated at test end.
No clinical signs and no mortality were observed. There were no treatment-related effects on body weight and nothing abnormal was found in the animals necropsied on Day 14.
The acute oral median lethal dose (LD50) of the test substance was therefore considered to be > 5 mL/kg = 4,952 mg/kg bw.
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