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EC number: 218-076-0 | CAS number: 2049-95-8
- 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:
- 14 to 15 June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- OECD Guideline 4.1 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tert-pentylbenzene
- EC Number:
- 218-076-0
- EC Name:
- tert-pentylbenzene
- Cas Number:
- 2049-95-8
- Molecular formula:
- C11H16
- IUPAC Name:
- (2-methylbutan-2-yl)benzene
- Details on test material:
- - Analytical purity: 97.4%
- Impurities: Cumene: 0.7%, Heptylbenzene (C13H18): 0.6%, Nonylbenzene (C15H22): 0.6%
- Lot/batch No.: Tank BV1112 du 18 avril 2007.
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek Corporation, Ashland MA, U.S.A.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEST SYSTEM
- Test system: The EpiDerm Skin Model consists of human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differential model of the human skin epidermis.
- Source: MatTek Corporation, Ashland MA, USA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 36 +/- 1°C
- Humidity (%): 80 - 100% containing 5 +/- 0.5% CO2SKIN DISC PREPARATION
- Quality control for skin discs: Electrical resistance obtained with two of the isolated skin discs was [complete, e.g. 10 kΩ]
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if [complete, e.g. if the mean TER value is less than or equal to 5 kΩ and the skin disk is obviously damaged, or if the mean TER value is less than or equal to 5 kΩ, and the skin disc is showing no obvious damage, but the mean disc dye content is greater than or equal to the mean disc dye content of the 10M HCl positive control obtained concurrently.]
- The test substance is considered to be non-corrosive to skin if [complete, e.g. if the mean TER value obtained for the test substance is greater than 5 kΩ, or if the mean TER value is less than or equal to 5 kΩ, and the skin disc is showing no obvious damage, and the mean disc dye content is well below the mean disc dye content of the 10M HCl positive control obtained concurrently.] - Control samples:
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl of the undiluted test substances was added on top of the skin tissues into a 6-well plate. - Duration of treatment / exposure:
- 3 minutes or 1 hour.
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 3
Test system
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The tissues were washed with phosphate buffered saline to remove residual test substance.
- Time after start of exposure: 3 minutes and one hour exposure.
SCORING SYSTEM: Skin corrosion is expressed as the remaining cell viability following exposure of the test substance with either of the two exposuretimes. Cell viability was calculated for each tissue as percentage of the mean of the negative control tissues.
The test substance is corrosive if:
a) The relative mean tissue viability obtained after 3 min. treatment compared to the negative control tissues is decreased below 50%
b) In addition, a test substance considered non-corrosive after 3 min. is considered corrosive if the mean relative tissue viability after 1 hr treatment with the test substance is decreased below 15%.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- After 3 minutes of exposure
- Value:
- 91
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- After 1 hour of exposure
- Value:
- 100
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Mean tissue viability in the in vitro skin corrosion test
3 min application viability (percentage of control) |
1 hr application viability (percentage of control) |
|
Negative control |
100 |
100 |
Tertiary-amylbenzene |
91 |
100 |
Positive control |
15 |
13 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions of this study, Tertiary-amylbenzene is considered as not corrosive according to EU criteria.
- Executive summary:
In vitro skin corrosion test with Teriatiary-amylbenzene was performed according to OECD 431 and in compliance with GLP. The possible corrosive potential of Tertiary-amylbenzene was tested through topical application for 3 minutes and 1 hour, using a human skin model (EpiDerm (EPI-200)). Tertiary-amylbenzene was applied undiluted (50µL) directly on top of the skin tissue.
The positive control had mean relative tissue viability after 3 minutes exposure of 15%. The absolute mean OD540 (optical density at 540 nm) of the negative control was within the laboratory historical control data range. The maximum inter tissue variability in viability between two tissues treated identically was less than 23% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 13% 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 Tertiary-amylbenzene compared to the negative control tissues was 91% and 100% respectively.
Since the mean relative tissue viability for Tertiary-amylbenzene was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment, Tertiary-amylbenzene is considered to be not corrosive.
Under the test conditions of this study, it is concluded that this test is valid and that Tertiary-amylbenzene is not corrosive in the in vitro skin corrosion test.
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