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EC number: 246-466-0 | CAS number: 24800-44-0
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity of tripropylene glycol is low. In rats, LD50 value by oral route is >2000 mg/kg bw. In the acute dermal toxicity study with rabbits, LD50 was > 16320 mg/kg bw. In the acute inhalation toxicity study with rats, LC50 value was > 0.083 mg/L/8h, which corresponded to saturated vapor concentration of tripropylene glycol at ambient temperature and pressure.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with OECD guideline 401 and GLP by MHW Japan. The original report was requested, but could not be recovered, only the abstract in English was received. However, the study was considered acceptable by OECD SIDS.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Doses:
- 500, 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: No abnormal clinical signs were observed.
- Gross pathology:
- No remarkable changes were found in any of the animals necropsied.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predates OECD guidelines and GLP, minor restrictions in design and reporting, but otherwise adequate for assessment.
- Principles of method if other than guideline:
- Rats were exposed to saturated vapor of tripropylene glycol generated at room temperature for 8 h.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- The nonfasted animals were maintained on appropriate Rockland diets and water ad libitum except during period of manipulation or confinement.
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- Concentrated vapor was generated in a gas washing bottle by passing dried air at 2.5 l/min through a fritted glass disc immersed to a depth of at least 1-1/2 inches in the chemical which is delivered to rats in a 9-liter glass exposure chamber. Mean vapor concentration is calculated from the loss in weight of the liquid or estimated from the vapor pressure at the actual temperature of the chemical during aerosol.
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 8 h
- Concentrations:
- 0.083 mg/l
- No. of animals per sex per dose:
- 6 animals/dose, sex unspecified
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- LC50 was calculated by the moving average method based on a 14-day observation period.
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- > 0.083 mg/L air
- Exp. duration:
- 8 h
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: No clinical signs were observed.
- Body weight:
- Weight change: 50-80 g
- Gross pathology:
- No remarkable findings were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 83 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predates OECD guidelines and GLP, minor restrictions in design and reporting, but otherwise adequate for assessment.
- Principles of method if other than guideline:
- Neat tripropylene glycol was applied to the intact skin of the trunk of male albino rabbits for 24 h under occlusive dressing.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- The nonfasted animals were maintained on appropriate Rockland diets and water ad libitum except during period of manipulation or confinement. Rabbits were 3 to 5 months of age.
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Test substance was applied undiluted under impervious sheeting on the clipped intact skin of the trunk. Animals were immobilized for 24 hour contact period.
- Duration of exposure:
- 24 h
- Doses:
- 16.0 ml/kg bw
- No. of animals per sex per dose:
- 5 males/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- LD50 was calculated by the moving average method based on a 14-day observation period.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 16 320 mg/kg bw
- Remarks on result:
- other: Value in mg/kg bw was calculated based on the LD50 > 16 mL/kg bw and the relative density of the substance of 1.02.
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: There were no clinical signs.
- Gross pathology:
- Livers mottled and acini prominent, spleens congested, kidneys pale and mottled.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 16 320 mg/kg bw
Additional information
Two acute oral toxicity studies with rats are available for assessment, both leading to the same conclusion. The more recent study, conducted in accordance with OECD guideline 401 and with GLP, was conducted by the Ministry of Health and Welfare of Japan (MHW, 1993) and only the abstract in English could be recovered, despite the study was requested. Nevertheless, as the study was conducted within the HPV/SIDS framework and considered to be reliable by OECD SIDS (1994), it was selected as a key study. In this study, 5 male and 5 female rats were administered tripropylene glycol at dose levels 500, 1000 and 2000 mg/kg bw. No deaths occurred and no abnormal clinical signs or necropsy findings were noted. The LD50 was established to be over 2000 mg/kg bw/day.The supporting study (Chemical Hygiene Fellowship, 1974) confirmed this result, with LD50 = 11.5 g/kg bw (calculated based on the LD 50 of 11.3 mL/kg bw and density of tripropylene glycol of 1.02 g/cm3).
Two inhalation toxicity studies with rats have been located, both predating OECD guidelines and GLP. The earlier one, conducted by Dow Chemical Company (1967) used a non-standard method (Lc(t) 50 determination), exposing rats of vapors to tripropylene glycol generated at ca. 200 °C, and therefore was found to be unacceptable for assessment. In the most recent one, conducted by Chemical Hygiene Fellowship (1974), six rats of unspecified strain and sex were exposed to saturated vapors of tripropylene glycol generated at room temperature, corresponding to concentration of 0.083 mg/l for 8 hours. There were no deaths, clinical signs or remarkable necropsy findings. An LC50 value of > 0.083 mg/L/8h was concluded based on the results of this study.
One acute dermal toxicity study with rabbits, predating OECD guidelines and GLP, was available for assessment (Chemical Hygiene Fellowship, 1974). 16.0 mL of tripropylene glycol was administered to the intact skin of the trunk of male albino rabbits for 24 h under occlusive dressing. No animals died and no clinical signs were noted. The necropsy of survivors revealed mottled livers with prominent acini, congested spleens and pale and mottled kidneys. Based on the results of the test, the LD50 value in rabbits was determined to be > 16320 mg/kg bw (calculated based on the density of tripropylene glycol of 1.02 g/cm3).
Justification for classification or non-classification
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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