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EC number: 941-221-0 | CAS number: 203929-12-8
- 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 / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 February 2014 to 13 February 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in compliance with GLP regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- MTDID 30531
- IUPAC Name:
- MTDID 30531
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 30531
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 98.6%
- Purity test date: 10 January 2012
- Lot/batch No.: 41260127919/Lot2
- Storage condition of test material: At room temperature in the dark.
Constituent 1
Test animals
- Species:
- other: NA: in vitro method: Human-derived keratinocytes were utilized
- Strain:
- other: NA: in vitro method
- Details on test animals or test system and environmental conditions:
- Not Applicable: in vitro method
Test system
- Type of coverage:
- other: NA: in vitro method
- Preparation of test site:
- other: NA: in vitro method
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: None: in vitro method. Positive (KOH) and negative (Milli-Q water) controls were utilized.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 uL - Duration of treatment / exposure:
- 2 tissues were treated for 3 minutes, while another two were treated for an hour.
- Observation period:
- Tissues were washed following exposure, and incubated with MTT medium for 3 hours. Formazan was then extracted with 2 mL isopropanol and the amount of extracted formazan was determined spectrophotometrically.
- Number of animals:
- None: in vitro method.
- Details on study design:
- Human-derived keratinocytes were cultured to form a multilayered, highly differentiated model of the human epidermis. The tissues were kept refrigerated until the day of use, transferred to 6 well plates containing 0.9 mL DMEM medium, and then incubated for 2.5 hours at 37 C in 5% CO2. MTDID 30531 (50 uL) was applied to 2 tissues for a 3 minute exposure and to 2 tissues for 1 hour exposure. The negative control (Milli-Q water) and the positive control (Potassium hydroxide- 8.0 normal solution) were applied (50 uL of each) in the same manner. Following the exposure periods, the tissues were washed with phosphate buffered saline (PBS). The DMEM medium was replaced with 300 uL MTT medium and then all tissues were again incubated for 3 hours at 37 C in 5% CO2. The tissues were then washed with PBS and formazan was extracted with 2 mL isopropanol. The amount of extracted formazan was determined spectrophotometrically at 540 nm in triplicate. Cell viability was then calculated as a percentage of the mean of the control tissues, and skin corrosion potential calculated from the optical density at 540 nm (OD540) measurements.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Tissue viability compared to negative controls
- Basis:
- mean
- Time point:
- other: 3 minute and 60 minute
- Score:
- ca. 88 - ca. 95
- Remarks on result:
- other: 3 Min: 88%, 60 Min: 95%
- Irritant / corrosive response data:
- The mean tissue viability of test article treated cells was 88% of the negative control after a 3 minute exposure and 95% after 1 hour exposure. The controls performed as expected indicating that the test was valid
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Category 2 Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, the test article is not corrosive in the in vitro skin corrosion test model and met the requirements of the test
- Executive summary:
The skin corrosion potential of the test article (clear colorless liquid, Batch: 41260127919j/Lot 2) was evaluated in an in vitro human skin model test. METHODS: This study was performed in compliance with OECD GLP (1997). The study design was based on OECD Guideline No. 431 (2013) and EC 440/2008 (2008). Human-derived keratinocytes were cultured to form a multilayered, highly differentiated model of the human epidermis. The tissues were kept refrigerated until the day of use, transferred to 6 well plates containing 0.9 mL DMEM medium, and then incubated for 2.5 hours at 37 C in 5% CO2. The test article (50 uL) was applied to 2 tissues for a 3 minute exposure and to 2 tissues for 1 hour exposure. The negative control (Milli-Q water) and the positive control (Potassium hydroxide- 8.0 normal solution) were applied (50 uL of each) in the same manner. Following the exposure periods, the tissues were washed with phosphate buffered saline (PBS). The DMEM medium was replaced with 300 uL MTT medium and then all tissues were again incubated for 3 hours at 37 C in 5% CO2. The tissues were then washed with PBS and formazan was extracted with 2 mL isopropanol. The amount of extracted formazan was determined spectrophotometrically at 540 nm in triplicate. Cell viability was then calculated as a percentage of the mean of the control tissues, and skin corrosion potential calculated from the optical density at 540 nm (OD540) measurements. The mean tissue viability of test article treated cells was 88% of the negative control after a 3 minute exposure and 95% after 1 hour exposure. The controls performed as expected indicating that the test was valid. Based on the results of the study, the test article is not corrosive in the in vitro skin corrosion test model and met the requirements of the test. As the study was performed according to OECD 431, a classification of Category 2 irritant was assigned.
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