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EC number: 814-155-4 | CAS number: 13188-82-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2,2-dimethyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- EC Number:
- 814-155-4
- Cas Number:
- 13188-82-4
- Molecular formula:
- C9H14O4
- IUPAC Name:
- (2,2-dimethyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- Isolated bovine cornea: The test system is the isolated bovine cornea. Bovine eyes are obtained as a by-product of freshly slaughtered cattle (age of the animals: minimum 12 months, maximum 60 months) Schlachthof Alzey, Germany.
Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders that consists of anterior and posterior chambers. Both chambers were filled to excess with pre-warmed Eagle’s MEM (without phenol red) and then equilibrated in a vertical position at about 32°C for at least 1 hour.
After the equilibration period, the medium in both chambers was replaced by fresh pre-warmed medium and initial corneal opacity readings were taken for each cornea with an opacitometer. Any corneas that showed macroscopic tissue damage or an opacity value < 556 opacity units1 were discarded. The remaining corneas were then distributed into negative control, positive control and treatment groups. Each corneal holder was uniquely identified with a number on the chambers.
Each treatment group (test substance, the NC and the PC) consisted of 3 corneas. Before application, the medium in the anterior chamber was removed by using a syringe. 750 μL undiluted liquid test substance were applied into the anterior chamber by using a pipette. For the control tissues, 750 μL deionized water (negative control, NC) or 750 μL 100% ethanol / 100% dimethylformamide (positive controls, PC1 / PC2) were applied into the anterior chamber by using a pipette. The corneas were incubated in a horizontal position at about 32°C for approximately 10 minutes (liquids and surfactants). The test substance, the NC and the PC were then removed from the anterior chamber by using a syringe and the epithelium was washed at least 3 times with Eagle’s MEM (containing phenol red) and once with Eagle’s MEM (without phenol red). Both chambers were then refilled with fresh Eagle’s MEM (without phenol red).
The corneas were incubated for 2 further hours at about 32°C. After the incubation period, the medium was removed and both chambers were then refilled with fresh Eagle’s MEM.
Before measurement, each cornea was visually observed and observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer.
For determination of permeability, the medium in the anterior chamber was replaced by 1 mL sodium fluorescein solution (4 mg/mL for liquid test substances and surfactants) and incubated for 90 ± 5 minutes in a horizontal position at about 32°C. The amount of sodium fluorescein that permeated through the corneas into the posterior chamber was spectrophotometrically measured. Three aliquots per cornea were transferred to a 96-well microtiter plate and the optical density (OD490) was determined.
Negative control (NC): Deionized water
Positive control (PC): 100% ethanol (PC1) / 100% dimethylformamide (PC2) for liquid test substances and surfactants
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 6.5
Any other information on results incl. tables
Result BCOP:
Test substance |
Mean Opacity Value |
Mean Permeability Value |
Mean In Vitro Irritancy Score |
18/0245-1 |
6.5 |
0.002 |
6.5 |
NC |
4.3 |
0.001 |
4.4 |
PC1 |
24.8 |
0.751 |
36.1 |
PC2 |
102.1 |
0.389 |
107.9 |
Summary of individual test results and test strategy evaluation
Test Method |
Test Result |
Test Evaluation |
Evaluation Test Strategy |
BCOP Test |
The mean IVIS of the corneas treated with the test substance was 6.5. |
Not identified as corrosive or severe irritant |
Ocular irritant |
EpiOcular |
The final relative mean Ocular irritant viability of the tissues treated with the test substance was 32.5%. |
Irritant |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the results of the BCOP and EpiOcular Tests and by applying the evaluation criteria, it was concluded that Laromer IPGA shows an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen.
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