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Diss Factsheets
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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- 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 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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.: TB 41213-04-2
- Storage condition of test material: in the original container (blue metal can) at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: bred in the laboratory colony (Branchville)
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: 2.0 to 2.1 kilograms
- Housing: housed individually under standard laboratory conditions in the study room
- Diet (e.g. ad libitum): Blue Seal Rabbit Feed, ID 1053 KLA, or equivalent, supplemented with oats if necessary
- Water (e.g. ad libitum): potable municipal water ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 68-74ºF
- Humidity (%): 35-65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours on/12 hours off cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- One eye of each animal was dosed with 0.1 ml of the test substance, while the other eye served as an untreated control.
- Duration of treatment / exposure:
- The eyes were not washed after instillation of the test substance unless, one hour later, the accumulation of debris/discharge interfered with eye examination and this was noted in the observations.
- Observation period (in vivo):
- All treated and control eyes were graded and scored at approximatly 1, 24, 48 and 72 hours. If positive ocular scores persisted at 72 hours, those eyes were re-examined on Day 4 using the same criteria and every three or four days thereafter, until the irritation became "not positive" or the healing was considered likely to be very prolonged.
- Number of animals or in vitro replicates:
- 6 animals; 3 male, 3 female
- Details on study design:
- Twenty-four hours prior to dosing, both eyes of each rabbit were examined using a hand held ophthalmoscope and then by an ultraviolet light to detect fluorscein retentin. For this procedure one drop of Fluorescein Sodium Ophthalmic Solution USP was dropped onto the cornea and 10-15 seconds later it was washed away with tap water. The eyes were examined for dye retention. Only animals free of apparent ocular defects were selected for this study. At the time of dosing, the animal was held quiet and the lower lid was everted from the eyeball to form a cup into which the test substance was placed at the specified dose. The eyelids were then gently held together for one second. The eyes were not washed after instillation of the test substance unless, one hour later, the accumulation of debris/discharge interfered with eye examination and this was noted in the observations. Any reaction to the instillation of the test substance was noted. If any rabbit showed evidence of severe pain, the protocol required use of a local anesthetic, euthanasia of that animal, or termination of the test.
All treated and control eyes were graded and scored at approximatly 1, 24, 48 and 72 hours using the criteria established in the 'Illustrated Guide for Grading Eye Irritation by Hazardous Substances" which uses a modified Draize scoring method. A hand held ophthalmoscope or slit lamp was used to facilitate examination. In addition, at approximatly 24 and 72 hours, both eyes were examined using the fluorescein method as perviously described.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects at 24 h and thereafter
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects at 24 h and thereafter
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects at 24 hr and thereafter
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects at 24 hr and thereafter
- Irritant / corrosive response data:
- At one hour there was very slight irritation characterized by conjunctival redness (grade 1) in all eyes with two also showing chemosis (Grade 1). At 24 hours all eyes appeared normal and remained normal through 72 hours. At no time was there any corneal involvement and there was no corrosive effect on the eye.
- Other effects:
- No evidence of any systemic effect was observed. Immediately following application of the test substance to the dosed eyes there was no evidence of pain, such as prolonged blepharospasm, excessive struggling of vocalization.
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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