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EC number: 619-127-3 | CAS number: 95418-58-9
- 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
- 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
Materials and methods
- Principles of method if other than guideline:
- The study procedures were based on the following documents:
- The Ocular Toxicity Working Group (OTWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM), Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Bovine Corneal Opacity and Permeability (BCOP) Test Method, March 2006.
- In Vitro Techniques in Toxicology Database (INVITTOX) protocol 124. Bovine Opacity and Permeability Assay - SOP of Microbiological Associates Ltd., 1999.
- Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992. - GLP compliance:
- yes
Test material
- Reference substance name:
- 1-(tert-butoxy)-4-ethenylbenzene
- EC Number:
- 619-127-3
- Cas Number:
- 95418-58-9
- Molecular formula:
- C12H16O
- IUPAC Name:
- 1-(tert-butoxy)-4-ethenylbenzene
- Test material form:
- liquid
- Details on test material:
- Clear and colourless
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source:
Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, the Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions):
Eyes were collected and transported in physiological saline in a suitable container. The isolated corneas were stored at 32 °C in a petri dish with cMEM (Eagle’s Minimum Essential Medium) containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum.
- Indication of any existing defects or lesions in ocular tissue samples:
All eyes were carefully examined for defects by holding the eyes submersed in physiological saline. Those exhibiting unacceptable defects, such as opacity, scratches, pigmentation and neovascularization were discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl of undiluted test substance
POSITIVE CONTROL
- Amount: 750 µl
- Concentration: 10% (w/v) Benzalkonium Chloride solution prepared in physiological saline.
NEGATIVE CONTROL
- Amount: 750 µl
- Concentration: 0.9% (w/v) NaCl in milli-RO water - Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- 3 corneas for each treatment and control group.
- Details on study design:
- PREPARATION OF CORNEAS
The isolated corneas were mounted in a corneal holder (one cornea per holder) of MC2 with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 °C. The corneas were incubated for the minimum of 1 hour at 32 °C.
QUALITY CHECK OF THE ISOLATED CORNEAS
After the incubation period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations were performed on each of the corneas using an opacitometer. The opacity of each cornea was read against an air filled chamber, and the initial opacity reading thus determined was recorded. Corneas that had an initial opacity reading higher than 3 were not used.
NUMBER OF REPLICATES
Three corneas were selected at random for each treatment group.
NEGATIVE CONTROL USED
Physiological saline: 0.9% (w/v) NaCl in milli-RO water
POSITIVE CONTROL USED
The positive control was 10% (w/v) Benzalkonium Chloride solution prepared in physiological saline.
APPLICATION DOSE AND EXPOSURE TIME
The medium from the anterior compartment was removed and 750µl of the control or test substance was introduced onto the epithelium of the cornea. Corneas were incubated in a horizontal position (to ensure uniform distribution of the control or the test substance over the entire cornea) for 10 minutes at 32 °C.
TREATMENT METHOD: open chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least three times with cMEM. The medium in the posterior compartment was also removed and both compartments were refilled with fresh cMEM.
- Post-exposure incubation: the corneas were incubated for 120 minutes at 32 °C. After the completion of the incubation period opacity determination was performed.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacitometer OP-KIT, MC2
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490).
SCORING SYSTEM
In Vitro Irritancy Score (IVIS) = mean opacity value + (15 x mean OD490 value). Additionally the opacity and permeability values were evaluated independently to determine whether the test substance induced irritation through only one of the two endpoints.
DECISION CRITERIA:
In vitro score range In vitro classification
0-3 Non irritant
3.1-25 Mild irritant
25.1-55 Moderate irritant
55.1-80 Severe irritant
>80 Very severe irritant
Permeability values of >0.600 are considered severe irritant.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: permeability score
- Value:
- -0.006
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Value:
- -0.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
The mean in vitro irritancy score (uncorrected) obtained with the negative control was less than 3.1 indicating that the negative controls did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The ocular irritation properties of butoxystyrene were assessed on an isolated bovine cornea. The study procedures were based on recent BCOP documents. The possible ocular irritancy of butoxystyrene was tested through topical application for 10 minutes. The test substance was applied undiluted (750 µl) directly on top of the corneas. The in vitro irritancy scores of the corneas treated with butoxystyrene ranged from -0.1 to 0.0 with a mean of -0.1. Since all in vitro irritancy scores were less than 3.1 butoxystyrene was considered non irritant.
Finally, it is concluded that this test is valid and that butoxystyrene is non irritant in the Bovine Corneal Opacity and Permeability test under the described experimental conditions.
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