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EC number: 283-029-3 | CAS number: 84522-34-9
- 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:
- From 2017-06-06 to 2017-06-09
- 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 2016
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium 5-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazinecarboxamidate
- EC Number:
- 283-029-3
- EC Name:
- Sodium 5-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazinecarboxamidate
- Cas Number:
- 84522-34-9
- Molecular formula:
- C14H16N4NaO3S
- IUPAC Name:
- 5-methyl-N-[2-(4-sulfamoylphenyl)ethyl]pyrazine-2-carboxamide;sodium
Constituent 1
- Specific details on test material used for the study:
- Batch: 16024R046
Purity: 100.3%
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model
- Tissue batch number(s): 26424 Kit J
- Date of initiation of testing: 06 Jun 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: incubation of 3 minutes: at room temperature, others at 37.0 ± 1.0°C (actual range 36.5 - 37.6°C).
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: washed with phosphate buffered saline, the rinsed tissues were kept in 24 well plates on 300 μL DMEM until 6 tissues (= one application time) were dosed and rinsed.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT concentrate (5 mg/mL) diluted (1:5) with MTT diluent (supplemented DMEM).
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: two tissues for 3-minute exposure and two for a 1-hour exposure, for the negative and positive controls, 2 tissues for both the 3-minute and 1-hour time point
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 (volume or weight with unit): 26.0 to 42.6 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL Milli-Q water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL 8N KOH - Duration of treatment / exposure:
- 3-minute and 1-hour
- Number of replicates:
- two tissues for 3-minute exposure and two for a 1-hour exposure, for the negative and positive controls, 2 tissues for both the 3-minute and 1-hour time point
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 78
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: The relative mean tissue viability obtained after the 3-minute treatments with the test item
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 7.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: The relative mean tissue viability obtained after the 1-hour treatments with the test item
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: two freeze-killed tissues treated with test item and two freeze-killed negative control treated tissues were used for the cytotoxicity evaluation with MTT at each time point. The non-specific reduction of MTT by test item was -0.07% and -1.4% of the negative control tissues after 3 minutes and 1 hour respectively.
- Colour interference with MTT: a color change was observed by adding MTT-medium it was concluded that test item did interact with the MTT endpoint.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range.
- Acceptance criteria met for positive control: The mean relative tissue viability following the 1-hour exposure to the positive control was 4.4%.
- Acceptance criteria met for variability between replicate measurements: In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤10%, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test item is corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
- Executive summary:
In vitro skin corrosion test was performed using a human skin model according to OECD 431 (2016).
Skin tissue was moistened with 25 μL of Milli-Q water and at least 25 mg of the test item was applied directly on top of the skin tissue.
Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 78% and 7.2%, respectively. Because the mean relative tissue viability for the test item was below 15% after the 1-hour treatment the test item is considered to be corrosive.
In conclusion, the test item is corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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