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EC number: 608-245-0 | CAS number: 28770-01-6
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-11-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The rabbit enucleated eye test is used (in-house), as a first stage in the assessment of ocular irritancy potential. The preferred species of choice is the rabbit. The assay has undergone inter-laboratory validation and has been shown to reliably detect test materials that are negligible, or moderate to severe ocular irritants.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol
- EC Number:
- 608-245-0
- Cas Number:
- 28770-01-6
- Molecular formula:
- C8H17NO2
- IUPAC Name:
- 2-[2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol
- Test material form:
- other: liqiud
Constituent 1
Test animals / tissue source
- Species:
- other: rabbit enucleated eye
- Details on test animals or tissues and environmental conditions:
- not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: two control enucleated eyes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL to the surface of the cornea - Duration of treatment / exposure:
- 10 sec
- Duration of post- treatment incubation (in vitro):
- 60, 120, 180 and 240 minutes following treatment
- Number of animals or in vitro replicates:
- three enucleated eyes
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 20 mL saline solution
- Time after start of exposure: 10 sec after substance application
SCORING SYSTEM: Rabbit enucleated eye test parameter
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean - 60/120/180/240 min
- Value:
- >= 4
- Remarks on result:
- other: not reversible; Exceeds cut-off value indicating severe ocular irritation
- Irritation parameter:
- fluorescein leakage
- Remarks:
- uptake
- Run / experiment:
- mean - 60 min
- Value:
- >= 4
- Remarks on result:
- other: not reversible; Exceeds cut- off value indicating severe ocular irritation
- Irritation parameter:
- percent corneal swelling
- Remarks:
- (%)
- Run / experiment:
- mean - 60 min
- Value:
- 59.1
- Remarks on result:
- other: not reversible
- Irritation parameter:
- percent corneal swelling
- Remarks:
- (%)
- Run / experiment:
- mean - 120 min
- Value:
- 81.4
- Remarks on result:
- other: not reversible
- Irritation parameter:
- percent corneal swelling
- Remarks:
- (%)
- Run / experiment:
- mean - 240 min
- Value:
- 101
- Remarks on result:
- other: not reversible
- Irritation parameter:
- other: condition of corneal epithelium
- Remarks on result:
- other: sloughing
- Other effects / acceptance of results:
- Moderate loss of corneal transparency was noted in all test eyes during the study period. No corneal effects were noted in the control eyes during the study period.
Corneal swelling of the test eyes during the study period was considerably greater than that observed in the control eyes over the same period. Sloughing of the corneal epithelium was noted in all test eyes during the study period. The condition of the corneal epithelium of the control eyes appeared normal during the study period. Fluorescein uptake was noted in the test eyes 240 minutes after treatment. No fluorescein uptake was noted in the control eyes 240 minutes after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Following assessment of the in vitro eye corrosion test, the test material was considered to have the potential to cause severe ocular damage in vivo.
- Executive summary:
A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man.
0.1 mL of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32 ± 1.5 °C within the superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9 % Sodium Chloride).
Moderate loss of corneal transparency was noted in all test eyes during the study period. No corneal effects were noted in the control eyes during the study period. Corneal swelling of the test eyes during the study period was considerably greater than that observed in the control eyes over the same period. Corneal swelling of the test eyes during the study period was considerably greater than that observed in the control eyes over the same period. Fluorescein uptake was noted in the test eyes 240 minutes after treatment. No fluorescein uptake was noted in the control eyes 240 minutes after treatment. Following assessment of the data for all endpoints the test material was considered to have the potential to cause severe ocular damage in vivo.
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