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EC number: 941-484-1 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 3-methyl-1-octylpyridinium chloride and 4-methyl-1-octylpyridinium chloride
- EC Number:
- 941-484-1
- Molecular formula:
- not possible
- IUPAC Name:
- Reaction mass of 3-methyl-1-octylpyridinium chloride and 4-methyl-1-octylpyridinium chloride
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: EPISKIN-SM™ tissue (SkinEthic)
- Details on test animals or test system and environmental conditions:
- The EPISKIN-SMTM tissues are provided as kits (SkinEthic), consisting of the following components
relevant for this study:
1x EPISKIN-SM™ plate containing 12 reconstructed epidermis units (area: 0.38 cm2); each
reconstructed epidermis is attached to the base of a tissue culture insert with an O-ring set and
maintained on nutritive agar for transport (Lot: 14-EKIN-034)
1x 12-well assay plate
1x flask of sterile maintenance medium (basic medium for incubations, Lot: 14-MAIN3-039)
1x flask of sterile assay medium (basic medium for use in MTT assays, Lot: 14-ESSC-037)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: positive and negative control tissues
- Amount / concentration applied:
- Dose Groups
1. Negative control 50 μL 0.9% NaCl solution
2. Positive control 50 μL glacial acetic acid
3. Test Item 50 ± 3 μL (undiluted)
MTT stock solution will be diluted 1 + 9 with DMEM-based medium (final concentration 0.3 mg/mL) - Duration of treatment / exposure:
- 3 minutes, 60 minutes and 4 hours
- Number of animals:
- The test was performed on a total of 6 tissues for each test item and for the negative control, 2 replicates for each treatment period (3 min, 60 min and 4 h exposure time). For the positive control the test was performed with 2 replicates for the 4 h exposure time.
- Details on study design:
- 4 h experiment: the tissues were treated with each dose group in duplicate, starting with the negative control. Start time was recorded with dosing of the first tissue. Then the 12-well plate(s) were incubated for 4 h ± 10 min. at room temperature.
60 min. experiment: the tissues were treated with the test item and the negative control in duplicate, starting with the negative control. Start time was recorded with dosing of the first tissue. Then the 12-well plate(s) were incubated for 60 min. ± 5 min. at room temperature.
3 min. experiment: the tissues were treated with the test item and the negative control in duplicate, starting with the negative control. Start time was recorded with dosing of the first tissue. A constant time interval of e.g. 30 sec. was kept between dosing. After 3 min. of application, with forceps, the first insert was removed from the 12-well plate. Using e.g. a wash bottle the tissue was gently rinsed about 15 times with PBS to remove any residual test item. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper. The surface was swept with a cotton bud. The insert was placed in a prepared 2-well “holding plate“ containing pre-warmed assay medium per well. All inserts were treated in the same manner.
Then the inserts were transferred into a prepared 12-well “MTT assay plate“ containing prewarmed MTT solution. The plate was incubated for 3 h ± 15 min. at 37 °C, 5.0% CO2 / 95% air.
60 min and 4 h experiment: after 60 min. / 4 h application, with forceps, the first insert was removed from the 12-well plate. Using e.g. a wash bottle the tissue was gently rinsed about 15 times with PBS to remove any residual test item. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper. The surface was swept with a cotton bud. The insert was placed in a prepared 12-well “holding plate“ containing pre-warmed assay medium per well. All inserts were treated in the same manner.
Then the inserts were transferred into a prepared 12-well “MTT assay plate“ containing prewarmed MTT solution. The plate was incubated for 3 h ± 15 min. at 37 ± 1 °C, 5.0% CO2 / 95% air.
3 min., 60 min. and 4 h experiment: After the 3 h MTT incubation period the tissues were placed on blotting paper to remove excess liquid. Afterwards a total biopsy of the epidermis by using the biopsy punch was performed and the epidermis was separated from the collagen matrix with the aid
of forceps. Both parts (epidermis and collagen matrix) were transferred into suitable tubes and acidic isopropanol were added. Then the tubes were mixed on a vortex mixer. Extraction was carried out at room temperature overnight, protected from light.
At the end of the formazan extraction period the tubes were mixed by vortexing until solution color became homogeneous.
If any visible cell/tissue fragments were in suspension, the tubes were centrifuged at 500 rpm to eliminate the fragments and avoid possible interference with the absorbance readings.
Per each tissue aliquots of the extract were transferred into a 96-well plate and OD was measured at 570 nm without reference wavelength in a plate spectrophotometer.
Results and discussion
Any other information on results incl. tables
3 min.
Name |
Negative Control |
Test Item |
||
Tissue |
1 |
2 |
1 |
2 |
absolute OD570- values (raw data) |
0.966 |
0.976 |
0.885 |
0.910 |
0.944 |
0.960 |
0.882 |
0.888 |
|
mean OD570(mean of 2 aliquots) |
0.955 |
0.968 |
0.884 |
0.899 |
mean OD570(blank corrected) |
0.912 |
0.926 |
0.841 |
0.857 |
total mean OD570(mean of 2 replicate tissues, blank corrected) |
0.919* |
0.849 |
||
relative tissue viability [%] |
99.3 |
100.7 |
91.5 |
93.2 |
mean relative tissue viability [%] |
100 |
92 |
||
difference of relative tissue viability [%]*** |
1.5 |
1.6 |
*corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.
***difference between each two replicates is≤30% (in the range of 20 – 100% viability and for
ODs > 0.3).
60 min.
Name |
Negative Control |
Test Item |
||
Tissue |
1 |
2 |
1 |
2 |
absolute OD570- values (raw data) |
0.901 |
0.960 |
0.645 |
0.635 |
0.890 |
0.955 |
0.645 |
0.637 |
|
mean OD570(mean of 2 aliquots) |
0.895 |
0.957 |
0.645 |
0.636 |
mean OD570(blank corrected) |
0.853 |
0.915 |
0.603 |
0.594 |
total mean OD570(mean of 2 replicate tissues, blank corrected) |
0.884* |
0.598 |
||
relative tissue viability [%] |
96.5 |
103.5 |
68.2 |
67.2 |
mean relative tissue viability [%] |
100 |
68 |
||
difference of relative tissue viability [%]*** |
7.0 |
1.0 |
*corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.
***difference between each two replicates is≤30% (in the range of 20 – 100% viability and for
ODs > 0.3). 4 hName |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
absolute OD570 -values (raw data) |
0.922 |
0.842 |
0.238 |
0.238 |
0.077 |
0.061 |
0.894 |
0.829 |
0.227 |
0.226 |
0.076 |
0.062 |
|
mean OD570(mean of 2 aliquots of 1 tissue) |
0.908 |
0.835 |
0.232 |
0.232 |
0.076 |
0.061 |
mean OD570(blank corrected) |
0.866 |
0.793 |
0.190 |
0.189 |
0.034 |
0.019 |
total mean OD570(mean of 2 replicate tissues, blank corrected) |
0.829* |
0.190 |
0.026 |
|||
relative tissue viability [%] |
104.4 |
95.6 |
22.9 |
22.8 |
4.1 |
2.3 |
mean relative tissue viability [%] |
100 |
23 |
3** |
|||
difference of relative tissue viability [%]*** |
8.8 |
0.1 |
1.8 |
*corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.
**mean relative tissue viability of the two positive control tissues of the 4 h treatment period is ≤ 20%.
***difference between each two replicates is ≤ 30% (in the range of 20 – 100% viability and for ODs > 0.3).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In this study under the given conditions the test item showed corrosive effects. The relative mean tissue viability after 4 h treatment was decreased below 35%. Additionally, the relative mean tissue viability was decreased to less than 35% after 60 min. treatment. The test item is therefore
classified as “corrosive“ in accordance with optional UN GHS sub-category 1B/C.
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