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EC number: 246-770-3 | CAS number: 25265-71-8
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Oxydipropanol
- EC Number:
- 246-770-3
- EC Name:
- Oxydipropanol
- Cas Number:
- 25265-71-8
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 1,1-Oxydi-2-Propanol
- Details on test material:
- - Name of test material (as cited in study report): dipropylene glycol
- Physical state: clear viscous liquid
- Analytical purity: 100%
- Lot/batch No.: TB41213-04-2
- Supplier: Regwest Company
- Storage condition of test material: in the original container (blue metal can) at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: bred in the laboratory colony (Branchville)
- Age at study initiation: approximately 8 weeks of age
- Weight at study initiation: males 242 to 269 grams; females 189 to 209 grams.
- Fasting period before study: no data
- Housing: individually housed in wire cages under laboratory conditions in the study room
- Diet (e.g. ad libitum): Agway NIH-31M Rodent Diet or equivalent.
- Water (e.g. ad libitum): potable municipal water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 68-74ºF
- Humidity (%): 35-65%
- Photoperiod (hrs dark / hrs light): 12 hours on/12 hours off cycle
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other:
- Details on inhalation exposure:
- Each chamber used was made of plexiglass, and measured approximately 50.5 cm long x 29.5 cm high (semi-cylindrical), having a volume of 47.4 liters. A wire mesh floor was raised 5.0 cm from the floor of the chamber and on this the rats were individually caged in all wire-mesh cages. The total "volume" of the test animals was not more than 5% of the volume of the test chamber based on a 1:1 equivalence between body volume (ml) and body weight (g). On one side near the top of the exposure chamber was a portal through which the test substance and air flow were introduced, and at the opposite side near the bottom there was a portal for exhaust to which a vacuum pump was attached. Test substance generation was established and maintained from the DeVilbiss Glass Nebulizer by using a Gast Air Pump supplying air at a measured pressure. The test substance was delivered from the nebulizer which was maintained at the portal of the exposure chamber. The vapor or inlet tube was set to deliver the aerosol directly through the portal into the exposure chamber. In addition to the four hour exposure period, a period of time (t99) was allowed to compensate for the time required for delivery system stabilization to a nominal chamber concentration greater than 5 mg of test substance per liter of air or to the maximum concentration of aerodynamic particles at the "limit dose".
The time for stabilization of the system was determined by the formula t99 = 4.605 x a/b, where t99 = time required to reach 99% of desired concentration; a = volume of chamber (liters), b= flow rate through the chamber (l/min). - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- thrice by gravimetric measurement
- Duration of exposure:
- 4 h
- Concentrations:
- Mean 2.34 mg/ in the breathing zone
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observations: animals were observed from outside the chamber for mortality and pharmacotoxic signs hourly during the exposure period. Rats were observed immediately following the t99 period after they had been returned to standard cages and then at approximately 1, 3 and 5 hour following the exposure, and once daily thereafter. In addition, mortality was checked each afternoon (except weekends and holidays) for the remainder of the 14 day observation period.
- Weighing: was obtained on day 0 (before dosing) and on days 2, 3, 4, 7 and 14.
- Necropsy of survivors performed: yes. A postmorten examination of each animal was carried out with detailed examination of the nasal air passages, trachea, bronchii and lungs. Additionally, the gross necropsy included but was not limited to the following organs: heart, spleen, liver, adrenals, kidneys, urinary bladder, stomach, small intestine, large intestine and reproductive organs. Sections from the lungs and other parts of the respiratory tract exhibiting evidence of specific pathology related to test substance administration were retained in 10% buffered formalin until all rats had undergone necropsy. Unless histopathology of these tissus was considered essential to interpretation of the results, the preserved tissues were discarded. - Statistics:
- None used
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.34 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- There were no deaths
- Clinical signs:
- other: Control rats remained normal in appearance and behavior during exposure and during the subsequent 14-day observation period. Rats exposed to the test substance remained normal during the exposure period except for "wetting' of the fur due to deposition of
- Body weight:
- All exposed rats had a similar body weight gain compared to controls during the study.
- Gross pathology:
- Neither in the control group nor in the group exposed to the test substance were there any pathognomonic findings. All organs and tissues examined grossly, including the respiratory tract, appeared normal.
Any other information on results incl. tables
In rats exposed to the maximum attainable concentration of 2.34 mg/l of the test substance during a 4 -hour period there was no mortality. At this exposure level, rats appeared normal throughout the study.
Applicant's summary and conclusion
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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