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EC number: 208-857-4 | CAS number: 544-01-4
- 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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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex 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, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diisopentyl ether
- EC Number:
- 208-857-4
- EC Name:
- Diisopentyl ether
- Cas Number:
- 544-01-4
- Molecular formula:
- C10H22O
- IUPAC Name:
- 3-methyl-1-(3-methylbutoxy)butane
- Details on test material:
- - Name of test material (as cited in study report): Diisopentyl ether
- Analytical purity: 99.2%
- Lot/batch No.: TAP 625
- Storage condition of test material: 2-8 °C
Constituent 1
Test animals / tissue source
- Species:
- other: in-vitro test
- Strain:
- other: isolated bovine cornea
- Details on test animals or tissues and environmental conditions:
- TEST MATERIAL
- Source: slaughterhouse (Muller Fleisch GmbH, Birkenfeld, Germany)
- Acclimation period: the eyes were transported to the test facility in Hank's balanced salt solution (supplemented with 0.01% streptomycin and 0.01% penicillin). Then, the corneas were dissected and incubated in incubation medium at 32 +/- 1°C in an incubation chamber for 1 hour.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32 +/- 1°C
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control: physiological sodium chloride solution; positive control: 10% sodium hydroxide solution.
- Amount / concentration applied:
- An amount of 750 µl diisopentyl ether was applied directly on the corneas in such a way that the cornea was completely covered.
- Duration of treatment / exposure:
- The corneas were incubated in a horizontal position for 10 minutes at 32°C.
- Observation period (in vivo):
- Not applicable, the effects on the corneas was determined directly after the exposure period.
- Number of animals or in vitro replicates:
- Not applicable (in vitro study)
- Details on study design:
- The aim of this study was to evaluate the ocular irritancy of diisopentyl ether as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea.
PROTOCOL
- For each treatment group (negative control, positive control and test item), three replicates were used.
- The opacity of each cornea was determined before exposure.
- The corneas were exposed for 10 minutes.
- After the incubation the change in opacity for each individual cornea (including the negative control) was determined.
- Following the final opacity measurement, permeability of the cornea to Na-fluorescein was evaluated.
INTERPRETATION
The assay is considered acceptable if:
- The positive control gives an in vitro irritancy score (IVIS) that falls within two standard deviations of the laboratory historical mean value.
- The negative control response has to show an IVIS between 0 and 3.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro irritancy score (IVIS)
- A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score.
- Remarks on result:
- other: Diisopentyl ether did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.0080 after 10 minutes of treatment.
- Irritant / corrosive response data:
- The negative control showed no irritation (mean IVIS was 0.443). The positive control induced a very severe irritation on the cornea, mean IVIS was 195.5. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
The mean in vitro irritancy score of the test item was 0.008 after 10 minutes of treatment with diisopentyl ether. For this reason it can be concluded that diisopentyl ether is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Diisopentyl ether is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test.
- Executive summary:
A GLP compliant in-vitro study was performed according to OECD Guideline 437 in order to evaluate the ocular irritation properties of diisopentyl ether on an isolated bovine cornea. The possible ocular irritancy of diisopentyl ether was tested through topical application for approximately 10 minutes. For each treatment group (negative control, positive control and test item), three replicates were used. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.
After treatment, the IVIS (in vitro irritancy score) in the controls is within the acceptability criterion. The positive control showed clear irritating effects. Diisopentyl ether showed no effects on the cornea of the bovine eyes. The IVIS score is 0.008 and therefore it can be concluded that diisopentyl ether is not an eye irritant in the BCOP Test.
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