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Diss Factsheets
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EC number: 205-617-0 | CAS number: 144-15-0
- 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
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-12-08 - 2000-05-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996-03-22)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996-09-30)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate
- EC Number:
- 205-617-0
- EC Name:
- Tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate
- Cas Number:
- 144-15-0
- Molecular formula:
- C32H58O8
- IUPAC Name:
- 1,2,3-tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ATEHC
- Physical state: liquid
- Expiration date of the lot/batch: May 31, 2000
- Stability under test conditions: Stable; stability of test article dilution: 2 hours.
- Storage condition of test material: At room temperature (17-23°C) away from direct sunlight (dry).
- Other: Safety precautions - gloves, goggles and face mask were sufficient to assure personnel health and safety.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Females: 10 weeks, males: 8 weeks
- Fasting period before study: approximately 16.5 to 17.5 hours, but with free access to water
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433, batch no. 42/99, rat maintenance diet available ad libitum (except for the overnight fasting period prior to application).
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): relative humidity 40-70% (values above 70% during cleaning process possible)
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
- Other: Recorded music was played for approximately 8 hours during the light period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
DOSAGE PREPARATION: The test article was placed into a glass beaker on a tared Mettler balance and the vehicle (polyethylene glycol PEG 400) was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogenicity of the test article in the vehicle was maintained during treatment. The preparation was made shortly before each dosing. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 rats per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality / Viability - Four times during test day 1 and once daily during days 2-15; body weights - On test day 1 (pre-administration), 8 and 15; clinical signs - Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2-15.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was used as no deaths occurred.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the study.
- Clinical signs:
- other: No clinical signs were noted during the observation period.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Any other information on results incl. tables
The median lethal dose of the substance after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- The LD50 was identified to be >2000 mg/kg body weight. The test material did not induce treatment-related mortality. Further no clinical signs or macroscopic findings were observed.
- Executive summary:
tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate (ATEHC) was tested in an acute oral toxicity study according to the acute toxic class method (OECD 423 and EU method B.1 tris; 2000). Two groups, each using three female or three male HanIbm: WIST (SPF) rats, were treated with the test substance at 2000 mg/kg by oral gavage. The test article was suspended in vehicle (polyethylene glycol PEG 400) at a concentration of 0.2 g/mL and administered at a volume of 10 mL/kg. The animals were examined for clinical signs and mortality / viability. Body weights were recorded and all animals were necropsied and examined macroscopically. No death occurred during the study, also no clinical signs were noted during the observation period; the body weight of the animals was within the range commonly recorded for this strain and age and no macroscopic findings were observed at necropsy.
The median lethal dose after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred. The LD50 (rat) was identified to be >2000 mg/kg body weight, therefore the test material was considered to be relatively non-toxic under the conditions of the test.
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