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EC number: 203-613-3 | CAS number: 108-75-8
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2019-12-19 to 2020-01-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 06 July 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 18 June 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,4,6-trimethylpyridine
- EC Number:
- 203-613-3
- EC Name:
- 2,4,6-trimethylpyridine
- Cas Number:
- 108-75-8
- Molecular formula:
- C8H11N
- IUPAC Name:
- 2,4,6-trimethylpyridine
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: The EpiDerm™ tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™, Epi-200-SIT kit and MTT-100 assay, purchased from MatTek Corporation (82105 Bratislava, Slovakia)
- Tissue batch number: Lot No.: 30842
REMOVAL OF TEST MATERIAL AND CONTROLS
At the end of the treatment interval the tissues were gently rinsed with PBS several times in order to remove any residual test material. Excess PBS was removed by gently shaking the inserts and blotting the bottom with blotting paper.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 1 hour
- Spectrophotometer: microplate reader (Versamax® Molecular Devices)
The absorbance values were determined using the software SoftMax Pro Enterprise (version 4.7.1).
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA
- The test item is identified as non-irritant to skin in accordance with UN GHS / EU CLP “No Category” if the tissue viability after exposure and post-treatment incubation is more than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 30 µL
NEGATIVE CONTROL
DPBS (MatTek)
- Amount applied: 30 µL
POSITIVE CONTROL
5% SDS solution in deionised water (MatTek)
- Amount applied: 30 µL - Duration of treatment / exposure:
- After pre-warming of the EpiDerm™ tissues was completed, the negative and positive control, and the test item was added atop the tissues. The test item respectively controls were tested in triplicate tissues with an exposure time of 60 minutes. Within this period the 6-well plates were placed in the incubator for 34 minutes at standard incubation conditions. In the remaining period the plates were placed in a sterile bench at room temperature until the end of treatment.
- Duration of post-treatment incubation (if applicable):
- After treatment and washing, the tissues were incubated in 0.9 mL of fresh assay medium for 24 hours. After this incubation period the medium was changed and the tissues were incubated for another about 18 hours at standard incubation conditions. The complete incubation time was about 42 hours.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of 3 runs with 3 replicates each
- Value:
- 2.18
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: After treatment with the negative control the absorbance values were well within the required range of the acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues.
- Acceptance criteria met for positive control: Treatment with the positive control induced a decrease in the viability compared with the negative control to 2.91%, thus ensuring the validity of the test system
- Acceptance criteria met for variability between replicate measurements: The standard deviations between the three tissue percentage viability values of each group (test item, positive and negative controls) in the main test were below 18 (threshold according OECD 439: ≤ 18), thus ensuring the validity of the study.
Any other information on results incl. tables
Table 1: Results after treatment with 2,4,6-Collidine and the controls
Treatment Group | Tissue No. | OD 570 nm | Mean OD of 3 Wells | Mean OD of 3 tissues blank corrected | Rel. Viability [%] Tissue 1, 2 + 3 | Standard Deviation | Mean Rel. Viability [%] | ||
Well 1 | Well 2 | Well 3 | |||||||
Blank |
| 0.039 | 0.039 | 0.039 | 0.039 |
|
| ||
Negative control | 1 | 1.680 | 1.603 | 1.604 | 1.629 | 1.656 | 96.023 | 3.6 | 100.0 |
2 | 1.731 | 1.763 | 1.746 | 1.747 | 103.149 | ||||
3 | 1.711 | 1.696 | 1.718 | 1.708 | 100.828 | ||||
Positive control | 1 | 0.089 | 0.094 | 0.092 | 0.091 |
0.048
| 3.147 | 0.2 | 2.91 |
2 | 0.087 | 0.087 | 0.086 | 0.087 | 2.857 | ||||
3 | 0.084 | 0.084 | 0.085 | 0.084 | 2.714 | ||||
Test item | 1 | 0.080 | 0.079 | 0.079 | 0.079 | 0.036 | 2.406 | 0.2 | 2.18 |
2 | 0.072 | 0.072 | 0.073 | 0.072 | 1.999 | ||||
3 | 0.074 | 0.075 | 0.075 | 0.074 | 2.124 |
Applicant's summary and conclusion
- Interpretation of results:
- other: The test substance is irritant or corrosive to skin. Further information is necessary to decide if it is to be classifed into category 1 or 2 for skin irritation/corrosion.
- Conclusions:
- In this study and under the experimental conditions reported, the test item is irritant or corrosive to skin according to UN GHS and EU CLP regulation.
- Executive summary:
The in vitro study according to OECD Guideline No. 439 was performed to assess the irritation potential of the test item by means of the Human Skin Model Test. The test item did not prove to be a MTT reducer in the MTT interference pre-experiment. Also, its intrinsic colour was not intensive and it did not change colour when mixed with deionised water or isopropanol. Therefore, additional tests with freeze-killed tissues or viable tissues (without MTT addition) did not have to be performed. Each three tissues of the human skin model EpiDerm™ were treated with the test item, the negative control (DPBS) or the positive control (5% SDS) for 60 minutes. After treatment with the negative control the absorbance values were well within the required range of the acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues. Treatment with the positive control induced a sufficient decrease in the viability as compared to the negative control for the 60 minutes treatment interval, thus assuring the validity of the test system. After treatment with the test item the mean relative viability value was 2.18% compared to the relative absorbance value of the negative control. This value is below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is irritant or corrosive to skin.
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