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EC number: 239-799-8 | CAS number: 15707-23-0
- 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:
- 11 April 2017 - 21 June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: B.40 bis (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethyl-3-methylpyrazine
- EC Number:
- 239-799-8
- EC Name:
- 2-ethyl-3-methylpyrazine
- Cas Number:
- 15707-23-0
- Molecular formula:
- C7H10N2
- IUPAC Name:
- 2-ethyl-3-methylpyrazine
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: EpiDerm TM Kit (human-derived epidermal keratinocytes)
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- Epi-200 kits and MTT-100 assays were purchased from MatTek Corporation (Bratislava, Slovakia). EpiDerm™ tissues were shipped at 4 °C on medium-supplemented agarose gels in a 24-well plate. On day of receipt the pre-incubation phase of the EpiDerm™ tissues started.
- Justification for test system used:
- The EpiDerm TM is an in vitro system recommended by the corresponding guideline.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200 Kit
- Tissue batch number: 25811
- Date of initiation of testing: 2017-05-10
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C for 3 minutes; room temperature for 60 minutes
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 20 times
- Observable damage in the tissue due to washing: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL
- Incubation time: 3 h
- Spectrophotometer: Versamax Molecular Devices, Softmax Pro
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
The test substance is considered to be corrosive to skin if:
- < 50% after 3 minutes exposure
- ≥ 50% after 3 minutes exposure AND < 15% after 60 minutes exposure
The test substance is considered to be non-corrosive to skin if:
- ≥ 50% after 3 minutes exposure AND ≥ 15% after 60 minutes exposure - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL - Duration of treatment / exposure:
- 3 min and 60 min
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: relative absorbance (%)
- Run / experiment:
- 1_Exposure: 3 min
- Value:
- 97.1
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: relative absorbance (%)
- Run / experiment:
- 2_exposure: 3 min
- Value:
- 94.6
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: relative absorbance (%)
- Run / experiment:
- Corrected Mean_Exposure: 3 min
- Value:
- 91.5
- Irritation / corrosion parameter:
- other: relative absorbance (%)
- Run / experiment:
- 1_Exposure: 1 hour
- Value:
- 21.4
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: relative absorbance (%)
- Run / experiment:
- 2_Exposure: 1 hour
- Value:
- 24.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: relative absorbance (%)
- Run / experiment:
- Corrected Mean_Exposure: 1 hour
- Value:
- 6
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: yes, an additional test with freeze-killed tissues was performed to determine a correction factor for calculating the true viability in the main experiment
- Colour interference with MTT: none
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test item is considered to be corrosive to skin according to EU CLP and UN GHS.
- Executive summary:
An in vitro study was performed to assess the corrosive potential of the test substance by means of the Human Skin Model Test with EpiDerm™ tissues models.
The test item passed the colour interference pre-test. Since it proved to be a MTT reducer in the MTT interference pre-test, an additional test with freeze-killed tissues was necessary.
Independent duplicate tissues of EpiDermTM were exposed to the test item, the negative control (deionised water) or the positive control (8.0 N KOH) for 3 minutes and 1 hour, respectively.
Afterwards, the test and the control items were rinsed off the tissues, and a 3 hour incubation period (37 ± 1 °C, 5 ± 0.5 % CO2) with MTT solution followed. MTT solution was then aspirated from the wells and the wells were rinsed with DPBS. Inserts were transferred into new 24 well plates. The formazan salt was extracted for 17.6 hours at room temperature.
After exposure to the test item the corrected relative absorbance value decreased to 91.5% after 3 minutes exposure. After 1 hour exposure the corrected relative absorbance value was reduced to 6.0%. The 1-hour-value fell below the threshold for corrosivity which is defined to be 15%.
The required acceptability criteria were met.
The test item is considered to be corrosive.
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