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EC number: 603-121-2 | CAS number: 126121-35-5
- 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:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Both the source and target substances in this read across are mono-constituent substances composed of the
same chemical groups and linked together in functionally the same way. The impurities present in both
substances are structurally similar to the source and target substances and are not expected to impact on the
predicted result, or reliability of the predicted result.
No toxicological effects were observed during the acute toxicity study conducted on the source substance. The
acute oral LD50 was set at >5000 mg/kg bw based upon the test dose of 5000 mg/kg bw. Due to the structural
and functional similarities between the source and target substances the predicted acute oral toxicity result of
the target substance is also negative. The target substance fails to meet Lipinski’s rule of five, and is therefore
unlikely to be orally active (bioavailable). The acute oral toxicity potential of the target substance is expected to
be the same as the source substance. The predicted result is therefore considered by the registrant to be
acceptable for registration, classification and labelling, and PBT/vPvB purposes. - Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Read across
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study conducted before GLP was adopted in USA.
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Trihexadecyl citrate
- EC Number:
- 224-931-9
- EC Name:
- Trihexadecyl citrate
- Cas Number:
- 4560-68-3
- Molecular formula:
- C55H106O6
- IUPAC Name:
- trihexadecyl citrate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino (not otherwise specified).
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 218-260 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test article was used as received (sp.g. = 0.92).
- Doses:
- 5 g/kg bw
- No. of animals per sex per dose:
- 5 male 5 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 3, 6 and 24 hours and then daily
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacologic activity and drug toxicity - Statistics:
- Not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the study period.
- Clinical signs:
- other: No clinical signs were reported.
- Gross pathology:
- No effects were observed during necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article was determined to have an acute oral LD50 of >5000 mg/kg bw in rats under the conditions of the test.
- Executive summary:
In this study (equivalent to EPA OPPTS 870.1100), the test article was determined to have an acute oral LD50 of >5000 mg/kg bw in rats under the conditions of the test.
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