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Diss Factsheets
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EC number: 266-549-5 | CAS number: 67024-46-8
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 20, 2017 to November 09, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Isopropyl 2-ethylhexanoate
- EC Number:
- 266-549-5
- EC Name:
- Isopropyl 2-ethylhexanoate
- Cas Number:
- 67024-46-8
- Molecular formula:
- C11H22O2
- IUPAC Name:
- isopropyl 2-ethylhexanoate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The EpiOcular™ human cell construct (MatTek Corporation) is used in this assay.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Approximately 50 μL test item was applied topically onto the EpiOcular™ tissues.
- Duration of treatment / exposure:
- The plates with the treated tissue units were incubated for the exposure time of 30 minutes (± 2 min) at standard culture conditions (37±1°C in an incubator with 5±1% CO2, 90±10% humidified atmosphere).
- Duration of post- treatment incubation (in vitro):
- After the post-incubation the EpiOcular™ units were transferred into the MTT ready to use solution filled 24-well plate (300 μL of 1 mg/mL MTT per well) and then incubated for 3 hours (± 10 min) at 37±1°C in an incubator with 5±1 % CO2 protected from light, 90±10% humidified atmosphere.
- Number of animals or in vitro replicates:
- Two replicates were used for the test item and control(s) respectively.
- Details on study design:
- Disks of EpiOcular™ (two units) were treated with (50 μL/units) test item and incubated for 30 minutes (± 2 min) at standard culture conditions (37±1°C) in an incubator with 5±1 % CO2, 90±10% humidified atmosphere).
Exposure to the test item was terminated by rinsing with Ca++Mg++ Free-DPBS solution. After rinsing, the tissues were incubated for a 12 ± 2 minutes immersion incubation (Post-Soak) at room temperature. At the end of the Post-Soak immersion the test item treated tissues were incubated for 120 minutes ± 15 minutes at standard culture conditions (Post-treatment Incubation). Fresh Assay Medium was used during the Post-Soak and Post-Incubation. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37±1°C in an incubator with 5±1 % CO2 protected from light, 90±10% humidified atmosphere. The precipitated formazan was then extracted using isopropanol and quantified spectrophotometrically.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Tissue viability
- Remarks:
- The test item is identified as not requiring classification and labelling according to UN GHS (No Category) if the mean percent tissue viability after exposure and post-exposure incubation is more than (>) 60%.
- Run / experiment:
- Run 1, viability 80%; Run 2, viability 76%.
- Value:
- 76
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained from this in vitro eye irritation test, using the EpiOcular™ model, indicated that the test item has no eye irritation potential under the testing conditions used. According to the current OECD Guideline No. 492, Isopropyl 2-ethylhexanoate is, thus, considered as non-irritant to eye (UN GHS No Category).
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