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EC number: 815-031-2 | CAS number: 1411949-02-4
- 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:
- key study
- Study period:
- from 2017-05-05 to 2017-05-05
- 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 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)
- Version / remarks:
- 2013-07
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-isobutyl-4-vinyl-1,3-dioxolane
- EC Number:
- 815-031-2
- Cas Number:
- 1411949-02-4
- Molecular formula:
- C9H19O2
- IUPAC Name:
- 2-isobutyl-4-vinyl-1,3-dioxolane
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Aschaffenburg, 63739 Aschaffenburg, Germany
- Characteristics of donor animals: at least 9 months old
- Storage temperature: ambient temperature
- Transport conditions of ocular tissue: The isolated eyes were transported to the laboratory in HBSS containing 1% (v/v) Penicillin/Streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin).
- Time interval prior to initiating testing: The corneae were isolated on the same day after delivery of the eyes and were directly used in the BCOP test.
- Indication of any existing defects or lesions in ocular tissue samples: Eyes presenting defects such as vascularization, pigmentation, opacity and scratches were discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.75 mL - Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3 corneas per group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea.
Each isolated cornea was mounted in a specially designed cornea holder according to the description given in OECD guideline 437. The endothelial side of the cornea was positioned against the sealing ring (Oring) of the posterior part of the holder. The cornea was gently flattened over the O-ring but stretching was avoided. The anterior part of the holder was positioned on top of the cornea and fixed in place with screws. Both compartments of the holder were filled with incubation medium. The posterior compartment was filled first. Care was taken to assure no air bubbles were present within the compartments. The corneae in the holder were incubated in a vertical position for about one hour at 32 ± 1 °C in a water-bath.
QUALITY CHECK OF THE ISOLATED CORNEAS
All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded. At the end of the incubation period, the basal opacity was determined (t0). Each corneae with a value of the basal opacity > 7 was discarded.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: Yes
POSITIVE CONTROL USED: Yes
APPLICATION DOSE AND EXPOSURE TIME: 0.75 mL and 10 min
POST-INCUBATION PERIOD: yes (2 hours)
REMOVAL OF TEST SUBSTANCE
- POST-EXPOSURE INCUBATION: 2 hours
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: OP_KIT opacitometer (changes in the light transmission passing through the cornae)
- Corneal permeability: Microtiter plate reader (OD490, passage of sodium fluorescein dye)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
IVIS ≤ 3 No Category (UN GHS)
IVIS > 3; ≤ 55 No prediction can be made
IVIS > 55 Category 1 (UN GHS)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 1.42
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- not valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
Any other information on results incl. tables
Table 1: Results after 10 Minutes Treatment Time
Test Group |
Opacity value = Difference (t130 –t0) of Opacity |
Permeability at 490 nm (OD490) |
IVIS |
Mean IVIS |
Proposed in vitro Irritancy score |
||
|
|
Mean |
|
Mean |
|
|
|
Neg. Control |
0 |
0.00 |
0.070 |
0.073 |
1.05 |
1.09 |
Not categorized |
0 |
0.062 |
0.93 |
|||||
0 |
0.086 |
1.29 |
|||||
Pos. Control |
57.00* |
1.065* |
72.98 |
83.62 |
Category I |
||
65.00* |
1.433* |
86.50 |
|||||
69.00* |
1.491* |
91.37 |
|||||
Test item |
2.00* |
-0.020* |
1.71 |
1.42 |
Not categorized |
||
2.00* |
-0.014* |
1.80 |
|||||
1.00* |
-0.017* |
0.75 |
*corrected values
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the OECD 437 study, the test item does not show eye irritating properties..
- Executive summary:
In an in vitro study according to OECD TG 437, the corneal damage potential of the test item was assessed. After a first opacity measurement of the fresh bovine corneae (t0), 0.75 mL of the neat test item, the positive control (2-Ethoxyethanol), and the negative control (saline) were applied to corneae and incubated for 10 minutes at 32 ± 1 °C. After the incubation phase, the test item, the positive, and the negative controls were each rinsed from the corneae. Further, the corneae were incubated for another 120 minutes at 32 ± 1 °C in incubation medium, and opacity was measured a second time (t130).
After the opacity measurements, permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. The test item was tested undiluted. Relative to the negative control, the test item caused no increase of the corneal opacity and permeability. The calculated mean IVIS was 1.42 (threshold for no categorisation: IVIS ≤ 3). The required acceptability criteria were met. The test item is not considered to be classified as eye irritating.
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