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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 13 April 2004
- 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
In vitro test system
- Test system:
- human skin model
- Cell source:
- other: MatTek Corporation, Ashland MA, USA
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model (EPI-200)
- Tissue batch number(s): 9640 kit T
- Storage and preparation:
On the day of receipt the tissues were kept on agarose and stored in the refrigerator. The next day, at least one hour before the assay is started the tissues were transferred to 6-well plates containing 0.9 ml DMEM medium per well. The medium was replaced with fresh DMEM medium just before butoxystyrene was applied.
ENVIRONMENTAL CONDITIONS
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation: 37 °C
- Humidity: 80-100%.
Temporary deviations from the humidity (with a maximum of 8%) occurred that were caused by opening and closing of the incubator door, but the time of these deviations did not exceed 1 hour. It is only a minor deviation in the humidity and the OD540 of the negative and positive controls were all within the historical data range. Therefore this deviation has no effect on the results of the study.
- CO2 percentage in the air: 5%
- Photoperiod: dark
REMOVAL OF TEST MATERIAL AND CONTROLS
After the exposure period, the tissues were washed with phosphate buffered saline to remove residual test substance.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/ml
- Incubation time: 3 h
- Spectrophotometer: Multiskan Spectrum (Thermo Labsystems)
- Wavelength: 540 nm
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µl of undiluted test substance
NEGATIVE CONTROL
- Amount(s) applied: 50 µl of Milli-Q water
POSITIVE CONTROL
- Amount(s) applied: 50 µl
- Concentration: 8N potassium hydroxide - Duration of treatment / exposure:
- Two time periods were used for exposure to the test substance: 3 minutes and one hour.
- Duration of post-treatment incubation (if applicable):
- For cell viability measurement, tissues were incubated for 3 h at 37 °C in air containing 5 ± 0.5% carbon dioxide.
- Number of replicates:
- The test was performed on a total of 4 tissues per test substance (two for 3 min exposure and two for 1 h exposure) together with a negative control and positive control for each exposure period.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- The relative mean tissue viability obtained after 1 hour treatment with butoxystyrene compared to negative control tissues.
- Value:
- 121
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- The relative mean tissue viability obtained after 3 minutes treatment with butoxystyrene compared to negative control tissues.
- Value:
- 112
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
The absolute mean optical density at 540 nm of the two tissues of the negative control was within the laboratory historical control data range.
- Acceptance criteria met for positive control:
The mean relative tissue viability of the 3 minutes exposure of the positive control was 4% (should be < or = 30%).
- Acceptance criteria met for variability between replicate measurements:
a) The maximum inter tissue variability (in viability) was less than 3% between two tissues treated identically (should be max. 30%).
b) The maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 2% (should be max. 15%).
It was therefore concluded that the test system functioned properly.
Any other information on results incl. tables
The relative mean tissue viability obtained after 3 minutes and 1 hour treatment with butoxystyrene compared to the negative control tissues was 112% and 121% respectively.
It was noted that butoxystyrene had affected the cell culture insert of the skin tissue after exposure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Butoxystyrene is not corrosive in the in vitro skin corrosion test under the described experimental conditions.
- Executive summary:
The corrosive properties of butoxystyrene on a human three dimensional epidermal model (EpiDerm (EPI-200)) were studied. The possible corrosive potential of butoxystyrene was tested through topical application for 3 minutes and 1 hour.
Butoxystyrene was applied undiluted (50 µl) directly on top of the skin tissue. The positive control had a mean relative tissue viability after 3 minutes exposure of 4%. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter tissue variability in viability between two tissues treated identically was less than 3% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 2%, indicating that the test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3 minutes and 1 hour treatment with butoxystyrene compared to the negative control tissues was 112% and 121% respectively. Since the mean relative tissue viability for butoxystyrene was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment butoxystyrene is considered to be not corrosive.
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