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EC number: 434-600-2 | CAS number: 2628-16-2
- 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:
- 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 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:
- 09 October 2017
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 434-600-2
- EC Name:
- -
- Cas Number:
- 2628-16-2
- Molecular formula:
- CH3CO2C6H4CH=CH2
- IUPAC Name:
- 4-ethenylphenyl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- purity: 98.4%
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Test system:
Freshly isolated bovine cornea obtained as a by-product from animals freshly slaughtered
- Source: A. Moksel AG, Buchloe, Germany
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 mL of the test item, the negative or positive control
- Duration of treatment / exposure:
- - 10 minutes incubation at 32 ± 1 °C, washed at least three times with MEM (containing phenol red)
- Duration of post- treatment incubation (in vitro):
- - illuminance measurement was performed after 2 hours incubation with RPMI at 32 ± 1 °C
- After the illuminance measurement the corneas were incubated for 90 minutes with RPMI and sodium fluorescein solution at 32 ± 1 °C for the optical density determination - Number of animals or in vitro replicates:
- 3 corneas/group
- Details on study design:
- Preparation of the Corneas
On the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS
containing Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation was initiated.
The eyes were carefully examined for defects and any defective eyes were discarded.
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2
to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS. Before the
corneas were mounted in corneal holders (Duratec GmbH) with the endothelial side against the O-ring
of the posterior chamber, they had been visually examined for defects and any defective cornea had
been discarded. The anterior chamber was then positioned on top of the cornea and tightened with screws.
The chambers of the corneal holder were then filled with RPMI (without phenol red) containing
1% FBS and 2 mM L-glutamine (complete RPMI). The posterior chamber was always filled first. The
corneas were incubated for one hour at 32 ± 1 °C.
Treatment of the Corneas
After the equilibration period, the medium was removed from both chambers and replaced with fresh
complete RPMI. An initial measurement was performed on each of the corneas using the opacitometer.
Three corneas with illuminance readings approximately equivalent to the median illuminance of all
corneas were selected as negative-control corneas. The illuminance of each cornea was read and re
corded. Only corneas that had an initial illuminance reading I > I0/1.1651 lux were used for the assay.
The medium was removed from the anterior chamber and replaced with the test item or control.
0.750 mL of the test substance or the control substance was introduced into the anterior chamber. Af
ter 10 minutes incubation at 32 ± 1 °C either the test substance or the control substance was removed
and the epithelium washed at least three times with MEM (containing phenol red). Once the medium
was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red).
The anterior chamber was refilled with complete RPMI and an illuminance measurement was p
erformed after 2 hours incubation at 32 ± 1 °C. Also, each cornea was observed visually and pertinent
observations were recorded.
After the illuminance measurement was performed, the medium was removed from both chambers
of the holder. The posterior chamber was refilled with fresh complete RPMI. 1 mL of a 4 mg/mL
sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for
90 minutes at 32 ± 1 °C. Then the medium from the posterior chamber was removed and its optical
density at 490 nm (OD490) was determined, using a spectrophotometer (Jenway 6405 UV/VIS).
Test Groups
3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive controls treated with ethanol 100%
Validity of the assay:
The BCOP assay is considered to be valid if the in vitro irritation score obtained with the positive control falls within the two standard deviations
of the current historical mean.
The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background
bovine corneas treated with the respective negative control.
Evaluation of Results:
The following formula was used to calculate the opacity, whereas the values a and b are equipmentspecific
variables empirically determined by the manufacturer: Opacity= ( I0/I-b)/a; with a = 0.025 and b = 0.9894.
The change in opacity for each cornea was calculated by subtracting the initial opacity
reading from the final opacity reading. These values were corrected by subtracting from
each the average change in opacity observed for the negative-control corneas. The
mean opacity value for each treatment was calculated by averaging the corrected
opacity values of each cornea for a given treatment.
The final-corrected OD490 of the test article and the positive control were calculated by subtracting the average-corrected OD490 of the
negative-control corneas from the corrected OD490 value of each treated cornea:
Final-corrected OD490 = (OD490 – mean blank OD490) – average-corrected negative control OD490
The mean OD490 value of each treatment group was calculated by averaging the final
corrected OD490 values of the treated corneas for that treatment condition.
The following formula was used to determine the in vitro irritation score (IVIS):
IVIS = mean opacity value + (15 x mean permeability OD490 value)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean of 3 corneas / 10 min incubation time
- Value:
- 1.26
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The in vitro irritation score obtained with the positive control fell within the two standard
deviations of the current historical mean and therefore this assay is considered to be
valid.
The negative control responses resulted in opacity and permeability values that are less
than the established upper limits for background bovine corneas treated with the
respective negative control.
Any other information on results incl. tables
In Vitro Irritation Score
Cornea no. | Test item | Corrected opacity | Corrected OD490 value | IVIS |
1 | Negative control | 0.11 | 0.004 | 0.48 |
2 | 0.68 | 0.005 | ||
3 | 0.47 | 0.003 | ||
MV | 0.42 | 0.004 | ||
4 | Positive control | 22.29 | 1.178 | 52.16 |
5 | 35.57 | 1.776 | ||
6 | 23.62 | 2.046 | ||
MV | 27.16 | 1.667 | ||
7 | Test item | 1.28 | 0.002 | 1.26 |
8 | 0.55 | 0.004 | ||
9 | 1.83 | 0.002 | ||
MV | 1.22 | 0.003 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the evaluation criteria the test item 4-acetoxystyrene is classified into UN
GHS No Category. - Executive summary:
The eye irritancy potential of 4-acetoxystyrene was investigated in the bovine corneal opacity and permeability assay according to OECD 437 and in compliance to GLP.
All 3 corneas treated with 4-acetoxystyrene showed a very slight opacity of the tissue. The following mean in vitro irritation score (IVIS) was calculated: 1.26
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid. The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
Therefore the test item was classified into UN GHS No Category.
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