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EC number: 608-855-7 | CAS number: 33288-71-0
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 2017-04-14 to 2017-05-19
- 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 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- other: Direct Peptide Reactivity Assay (DPRA)
Test material
- Reference substance name:
- 5-Methyl-N-(2-(4-sulfamoylphenyl)ethyl)pyrazine-2-carboxamide
- Cas Number:
- 33288-71-0
- Molecular formula:
- C14-H16-N4-O3-S
- IUPAC Name:
- 5-Methyl-N-(2-(4-sulfamoylphenyl)ethyl)pyrazine-2-carboxamide
Constituent 1
- Specific details on test material used for the study:
- Batch: 16005R064
Purity: 99.3%
In chemico test system
- Details on the study design:
- Test system
- Test system: Synthetic peptides containing cysteine (SPCC) or synthetic peptides containing lysine (SPCL).
- Rationale: Recommended test system in the international OECD guideline for DPRA studies.
- Source: JPT Peptide Technologies GmbH
Experimental Design
- Test Item Preparation: 14.41 mg of test item was pre-weighed into a clean amber glass vial and dissolved, just before use, in 1799 μL ACN to obtain a 25 mM solution.
- Preparation of Solutions for Cysteine Reactivity Assay:
Synthetic Peptide Containing Cysteine (SPCC) Stock Solution: A stock solution of 0.667 mM SPCC (0.501 mg SPCC/mL) was prepared by dissolving 10 mg of SPCC in 19.96 mL phosphate buffer pH 7.5. The mixture was stirred for 5 minutes followed by 5 minutes sonication.
SPCC Reference Control Solutions: Three 0.5 mM SPCC reference control (RC) solutions (RCcysA, RCcysB and RCcysC) were prepared in amber vials by mixing 750 μL of the 0.667 mM SPCC stock solution with 250 μL ACN.
- Preparation of Solutions for Lysine Reactivity Assay:
Synthetic Peptide Containing Lysine (SPCL) Stock Solution: A stock solution of 0.667 mM SPCL (0.518 mg SPCL/mL) was prepared by dissolving 10 mg of SPCL in 19.31 mL of ammonium acetate buffer pH 10.2 followed by stirring for 5 minutes.
SPCL Reference Control Solutions: Three 0.5 mM SPCL reference control (RC) solutions (RClysA, RClysB and RClysC) were prepared in amber vials by mixing 750 μL of the 0.667 mM SPCL stock solution with 250 μL ACN.
- Sample Incubations: After preparation, the samples (reference controls, calibration solutions, co-elution control, positive controls and test item samples) were placed in the autosampler in the dark and incubated at 25±2.5°C. The incubation time between placement of the samples in the autosampler and analysis of the first RCcysB- or RClysB-sample was 24.5 hours. The time between the first RCcysB- or RClysB-injection and the last injection of a cysteine or lysine sequence, respectively, did not exceed 30 hours.
- HPLC-PDA Analysis: SPCC and SPCL peak areas in the samples were measured by HPLC-PDA.
- Other measurement: Prior to HPLC-PDA analysis the samples were visually inspected for precipitation.
Results and discussion
- Positive control results:
- The mean Percent SPCC Depletion for the positive control cinnamic aldehyde was 74.6% ± 1.5%. This was within the acceptance range of 60.8% to 100% with aSD that was below the maximum (SD<14.9%).
The mean Percent SPCL Depletion for the positive control cinnamic aldehyde was 63.4% ± 0.9%. This was within the acceptance range of 40.2% to 69.0% with a SD that was below the maximum (SD<11.6%).
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Cysteine Reactivity Assay
- Parameter:
- other: SPCC depletion%
- Positive controls validity:
- valid
- Remarks on result:
- other: In the cysteine reactivity assay the test item showed co-elution with SPCC and therefore no % SPCC could be calculated.
- Key result
- Run / experiment:
- other: Lysine Reactivity Assay
- Parameter:
- other: SPCL depletion%
- Value:
- 0.1
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - Precipitation: Cysteine Reactivity Assay: Upon preparation and after incubation, both the co-elution control (CC) as well as the test item samples were visually
inspected and a precipitate was observed in both the CC and test item samples; Lysine Reactivity Assay: Upon preparation as well as after incubation, a precipitate was observed in the CC and the test item samples.
- Test Acceptability: all acceptability criteria were met this DPRA is considered to be valid.
Any other information on results incl. tables
In the cysteine reactivity assay the test item showed co-elution with SPCCand therefore no % SPCC could be calculated. In the lysine reactivity assay the test item showed 0.1% SPCL depletion. Since no DPRA prediction and reactivity classification can be made based on SPCL depletion data alone, the DPRA results obtained for test item are inconclusive.
Applicant's summary and conclusion
- Interpretation of results:
- other: Inconclusive
- Conclusions:
- The test item was positive in the DPRA and was classified in the “low reactivity class” when using the Cysteine 1:10 prediction model.
- Executive summary:
The reactivity of test item towards model synthetic peptides containing either cysteine (SPCC) or lysine (SPCL) was determined according to OECD guideline 442C.
After incubation of test item with either SPCC or SPCL, the relative peptide concentration was determined by High-Performance Liquid Chromatography (HPLC) with gradient elution and photo diode array (PDA) detection at 220 nm and 258 nm. SPCC and SPCL Percent Depletion Values were calculated and used in a prediction model which allows assigning the test chemical to one of four reactivity classes used to support the discrimination between sensitizers and non-sensitizers.
In the cysteine reactivity assay the test item showed co-elution with SPCC and therefore no % SPCC could be calculated. In the lysine reactivity assay the test item showed 0.1% SPCL depletion. Since no DPRA prediction and reactivity classification can be made based on SPCL depletion data alone, the DPRA results obtained for test item are inconclusive.
In conclusion, since all acceptability criteria were met this DPRA is considered to be valid. The DPRA results obtained for test item were inconclusive.
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