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EC number: 947-766-0 | 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 irritation: in vitro / ex vivo
- Remarks:
- In vitro skin corrosion test with EpiDerm (EPI-200))
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 26, 2017 to July 27, 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:
- adopted 29 July 2016
- 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
Test material
- Reference substance name:
- Quaternary ammonium compounds, N,N,N'-tris(hydroxyethyl)-N,N'-dimethyl-N'-C16-18 (even numbered) and C18 unsatd., alkyltrimethylenedi-, bis(Me sulfates) (salts)
- EC Number:
- 947-766-0
- Molecular formula:
- Since the test substance is a complex UVCB, no defined molecular formula is available.
- IUPAC Name:
- Quaternary ammonium compounds, N,N,N'-tris(hydroxyethyl)-N,N'-dimethyl-N'-C16-18 (even numbered) and C18 unsatd., alkyltrimethylenedi-, bis(Me sulfates) (salts)
- Test material form:
- solid: bulk
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm Skin Model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts. Recommended test system in international guidelines (OECD and EC)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Test system specifications: Three-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum was supplied by MatTek In Vitro Life ScienceLaboratories, Bratislava, Slovak Republic.
System conditions: Human keratinocytes are used to construct the epithelium. Multiple layers of viable epithelial cells are present under a functional stratum corneum. The stratum corneum is multi-layered with the necessary lipid profile to produce a functional barrier. The containment properties of the model prevent the passage of material around the stratum corneum to the viable model tissue. The skin model was supplied free of contamination with bacteria, mycoplasma and fungi.
Assessment of MTT Interacting substances: In order to assess the potential non-specific reduction of the test substance, 50 μL of test substance was added to 1 mL of 1.0 mg/mL MTT and the colour change was assessedcafter incubation for 60 minutes at 37±1°C, 5±1% CO2, 95% RH. There was no change in colour therefore the test substance did not interact with MTT.
Assessment for colour interference: 50 μL of test substance was added to both 0.3 mL deionized water and isopropanol, before being incubated for 60 minutes at 37±1°C, 5±1% CO2, 95% RH. The solutions did not become coloured, therefore the test substance was deemed not to have the potential to stain the tissue.
Application of test and control substances: On the day of receipt EpiDermTM tissues were transferred to refrigerator at 2 to 8°C and stored overnight. The next day, approximately 1 hour before starting the assay, the tissues were prepared for treatment in labelled 6-well plates. The test was performed on a total of four tissues per test substance, negative and positive control, out of which two were used for a 3 minute application and two tissues were used for a 1 hour application. A volume of 50 μL of the undiluted test substance was applied to the tissue. Further tissues were concurrently treated with 50 μL distilled water (negative control) and with 50 μL 8M potassium hydroxide (positive control). After the 3 minute or 1-hour contact periods, the tissues were washed with phosphate buffered saline (PBS) to remove residual material. The rinsed tissues were kept in 24-well plates (holding plates) until all tissues were dosed and rinsed. The positive control material was a direct MTT reducer, therefore additional positive controls were performed. The positive control substance was applied to two freeze-killed tissues (thawed on the day of treatment) per exposure time.
Cell viability measurements: 1 mg/mL MTT-medium and were incubated for 3 hours (37±1°C, 5±1% CO2, 95% RH). After incubation any resultant colour was extracted with 2 mL isopropanol overnight. The optical density of each resultant extract was determined spectrophotometrically at 570 nm and cell viability was calculated for each tissue as a percentage of the mean of the negative control tissue. Skin corrosivity potential of the test substance was classified according to the remaining cell viability obtained after test substance treatment with either of the two treatment times. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 3 minutes and 1 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- cytotoxicity
- Run / experiment:
- 3 minutes treatment
- Value:
- ca. 82
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- cytotoxicity
- Run / experiment:
- 1 h treatment
- Value:
- ca. 73.9
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- -The test substance was checked for color interference in aqueous conditions and possible direct MTT reduction by adding the test substance to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that the test substance did not interfere with the MTT endpoint.
The mean absorption at 570 nm measured after treatment with the test substance and controls were as follows:
1) Negative control 1.100 (3 minute application) and 1.211 (1 h application)
2) Test substance 0.905 (3 minute application) and 0.894 (1 h application)
3) Positive control 0.294 (3 minute application) and 0.210 (1 h application)
- The mean tissue viability obtained after 3 minute and 1 h treatments with the test substance compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after the 3 minute and 1 h treatments with the test substance compared to the negative control tissues was 82% and 73.9% respectively. Because the mean relative tissue viability for the test substance was not below 50% after 3 minutes treatment and not below 15% after 1 h treatment the test substance is considered to be not corrosive.
- The OD values for the negative controls were between 0.8 and 2.8, and were within observed historical ranges. The mean relative tissue viability following the 1 h exposure to the positive control was 4.4%.
- In the range of 20 - 100% viability the coefficient of variation between tissue replicates was <30%, indicating that the test system functioned properly. The coefficient of variation between tissue replicates treated with the test substance was 5.9% for the 3-minute treatment, which is above acceptance criteria. Since all individual viabilities were >50%, the test outcome was considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Under the study conditions, the test substance was determined to be non corrosive to skin based on human three dimensional epidermal model (EpiDerm (EPI-200)).
- Executive summary:
An in vitro study was conducted to determine the skin corrosion potential of the substance according to OECD Guideline 431 and EU Method B.40 bis in compliance with GLP. The test substance was checked for colour interference in aqueous conditions and possible interference with MTT reduction by adding the test substance to MTT medium. Because the solutions did not turn blue/purple nor a blue/purple precipitate was observed, it was concluded that the test substance did not interfere with the MTT. Duplicate tissue sample were exposed to 50 µL test substance for 3 min and 1 h. Post treatment period, a determination of the cytotoxic effect was performed. Cytotoxicity was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Skin corrosion was expressed as the remaining cell viability after exposure to the test substance. The positive control had a mean relative tissue viability of 4.4% after the 1-h exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 and the laboratory historical control data range. In the range of 20 - 100% viability the coefficient of variation between tissue replicates was <30%, indicating that the test system functioned properly. The relative mean tissue viability obtained after 3 min and 1 h treatments with the test substance compared to the negative control tissues was 82% and 73.9%, respectively. Because the mean relative tissue viability for the test substance was above 50 and 15% after 3 min and 1 h treatment respectively, so the test substance is considered to be non-corrosive. Under the study conditions, the test substance was determined to be non-corrosive to skin based on human three dimensional epidermal model (EpiDerm (EPI-200)) (Payne, 2017).
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