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EC number: 202-632-4 | CAS number: 98-06-6
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Version / remarks:
- adopted: 25. June 2018
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- adopted 14. Feb. 2017
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- This in vitro study was performed to assess the potential of the test item tert-butylbenzene to activate the Nrf2 transcription factor by using the genetically modified keratinocyte cell-line “LuSens” OECD 442D(Bauch et al. 2012).
Test material
- Reference substance name:
- tert-butylbenzene
- EC Number:
- 202-632-4
- EC Name:
- tert-butylbenzene
- Cas Number:
- 98-06-6
- Molecular formula:
- C10H14
- IUPAC Name:
- tert-butylbenzene
- Test material form:
- liquid
- Details on test material:
- - Name of test material: tert-butylbenzene
- IUPAC name: tert-Butylbenzene
- Molecular formula: C10H14
- Molecular weight: 134.22 g/mol
- Substance type: Organic
- Physical state: Liquid
Constituent 1
In vitro test system
- Details on the study design:
- -Solvent: dimethyl sulfoxide (DMSO).
-Negative control: DL-Lactic acid.
-Positive control: EGDMA (Ethylene glycol dimethylacrylate)
-Cell line: LuSens cell line (BASF SE), are stored in liquid nitrogen in the cell bank of LAUS GmbH.
-Cell cultivate condition: 37 ± 1 °C in a humidified atmosphere with 5.0 ± 0.5 % CO2.
-Cell measurement: Cytotoxicity Range Finder Assay cells
-Chemicals and Media: Ca2+/Mg2+-Solution for PBS, EDTA Solution (250 g/L), FCS (Fetal Calf Serum) Superior, Lysepuffer Glo Lysis Buffer 1X.
-Test vessels: 96-well plates.
PERFORMANCE OF THE STUDY:
Cytotoxicity Range Finder Test:
Method: measuring the cell viability with MTT.
Exposure time: 48h
Nominal concentrations of the test item: 0.98 µM, 1.95 µM, 3.91 µM, 7.81 µM, 15.63 µM, 31.25 µM, 62.5 µM, 125 µM, 250 µM, 500 µM, 1000 µM, 2000 µM.
Dose Selection for Experiment I and II:
the following 12 nominal concentrations were chosen for experiment I and II:
33.6 µM, 40.4 µM, 48.5 µM, 58.1 µM, 69.8 µM, 83.7 µM, 100.5 µM, 120.6 µM, 144.7 µM, 173.6 µM, 208.3 µM, 250.0 µM
Results and discussion
- Positive control results:
- Experiment I: Induced a clear effect with an induction value of 4.6 fold in comparison to the solvent control.
Experiment II: Induced a clear effect with an induction value of 4.0 fold in comparison to the solvent control.
EGDMA (120 µM) was used as positive control. The viability was above 70 % and a distinct increase in luciferase induction above 2.5 fold in comparison to the solvent control was detected. This luciferase induction is well within the historical data range of the positive control.
In vitro / in chemico
Results
- Key result
- Value:
- 1.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: luciferase induction is < 1.5 fold
- Remarks:
- luciferase induction is < 1.5 fold
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test item, tert-Butylbenzene, was negative in the LuSens assay and is therefore considered not to have the potential to activate the Nrf2 transcription factor (no sensitizing potential).
- Executive summary:
Thisin vitrostudy evaluates the potential of the test itemtert-Butylbenzeneto activate the Nrf2 transcription factor (sensitizing potential) by using the LuSens cell line. This test is part of a tiered strategy for the evaluation of skin sensitization potential. Thus, data generated with the present Test Guideline should be used to support the discrimination between skin sensitizers and non-sensitizers in the context of an integrated approach to testing and assessment.
The LuSens test is an ARE Reporter Gene Assay based on the OECD 442D Guidelinewith the title “In Vitro Skin Sensitisation assays addressing the AOP Key Event on Keratinocyte activation”.
The assay included a cytotoxicity range finder test (CRFT) and two independent experiments (experiment I and II) with a treatment period of 48 h. The CRFT was performed to detect a potential cytotoxic effect of the test item. Based on the results of this test the concentrations for the two experiments were determined.
In the experiments, the highest nominal applied concentration (250 µM) was chosen based on the results obtained in the CRFT. A geometric series (factor 1.2) of eleven dilutions thereof was prepared. Precipitation of the test item was not visible in any of the experiments.
DMSO (final concentration: 1 %) was used as solvent control and medium no. 3 as growth control. Lactic acid (5000 µM) was used as negative control and EGDMA (120 µM) as positive control.
No substantial and reproducible dose-dependent increase in luciferase induction equal or above 1.5 fold was observed in both experiments up to the maximal tested concentration of the test item.
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