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Diss Factsheets
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EC number: 947-354-0 | 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- This is a non-GLP study, based on OECD test guideline 431 (In vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method).
Test material
- Reference substance name:
- 1-methyl-2-[(2-methyl-1-oxoallyl)oxy]ethyl hydrogen phthalate
- EC Number:
- 265-951-8
- EC Name:
- 1-methyl-2-[(2-methyl-1-oxoallyl)oxy]ethyl hydrogen phthalate
- Cas Number:
- 65859-45-2
- Molecular formula:
- C15H16O6
- IUPAC Name:
- 2-{[2-(methacryloyloxy)-1-methylethoxy]carbonyl}benzoic acid
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Test Material Name: Methacryloxyisopropyl acid phthalate
Lot/Reference/Batch Number: YY00GCV000
Purity/Characterization (Method of Analysis and Reference): The non-GLP purity of the test material was determined to be 62.8% (Sathiosatham, 2017).
Test Material Stability Under Storage Conditions: The record of custody lists the test material as having a 1 year shelf life (Sathiosatham, 2017).
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Cultured human derived epidermal keratinocytes, MatTek Corporation
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Experiment Procedure:
Upon receipt, the EpiDerm tissue transwell discs were stored at 2-8 ºC and used within 48 hours of receipt from the supplier. On the day prior to testing, each EpiDerm tissue transwell disc was inspected for air bubbles between the agarose gel and Millicell® insert prior to opening the sealed package. Tissue discs with air bubbles greater than 50% of the Millicell® area were not used for testing. An appropriate number of EpiDerm tissues were aseptically removed from the 24-well shipping plate and transferred to a 6-well plate containing pre-warmed assay medium. The EpiDerm tissues were then incubated at approximately 37ºC in a humidified atmosphere of approximately 5% CO2 for 18 ± 3 hours to acclimate the tissue prior to treatment.
Corrosion Experimental Procedure:
On the day of treatment, the EpiDerm tissues were transferred to new 6-well plates containing 0.9 mL/well of fresh pre-warmed assay medium and exposed to the test material (50 µL), in conjunction with negative (water) and positive controls (8N Potassium hydroxide solution (KOH)) for two exposure periods: 3 and 60 minutes. The 3 minute exposure groups were held at room temperature during the treatment incubation, while the 60 minute exposure groups were placed in the incubator at standard culture conditions (approximately 37ºC with 5% CO2/95% air) during treatment. Following the exposure period, the tissues were rinsed with sterile DPBS (approximately 20 times) to remove test substance (extra rinses were implemented as necessary). Following rinsing, tissue inserts were evaluated for cell viability using MTT assay. Each tissue insert was transferred to a well containing 300 µL MTT (1mg/mL) solution in a 24-well plate and tissues were incubated for 3 ± 0.1 hr at standard cell culture conditions. After incubation the tissues were washed with DPBS and formazan was extracted in 2 mL extractant solution (isopropanol) overnight at room temperature. The extract solution was mixed and 2 x 200 µL aliquots were transferred to the appropriate wells of a 96-well plate. The amount of extracted formazan was measured spectrophotometrically at 570 nm (OD570) with a Microplate Reader. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Preparation of the Test Material:
Test material(s) will be tested as neat (100%) or as provided, following the OECD 431 guideline.
Route of Administration:
The test material and control substances were administered by topical application to the tissue disc. In the corrosion assay, 50 μL of undiluted methacryloxyisopropyl acid phthalate was directly dispensed atop the tissue. - Duration of treatment / exposure:
- Corrosion Experimental Procedure:
On the day of treatment, the EpiDerm tissues were transferred to new 6-well plates containing 0.9 mL/well of fresh pre-warmed assay medium and exposed to the test material (50 μL), in conjunction with negative (water) and positive controls (8N Potassium hydroxide solution (KOH)) for two exposure periods: 3 and 60 minutes. The 3 minute exposure groups were held at room temperature during the treatment incubation, while the 60 minute exposure groups were placed in the incubator at standard culture conditions (approximately 37ºC with 5% CO2/95% air) during treatment. - Duration of post-treatment incubation (if applicable):
- Corrosion Experimental Procedure:
Following the exposure period, the tissues were rinsed with sterile DPBS (approximately 20 times) to remove test substance (extra rinses were implemented as necessary). Following rinsing, tissue inserts were evaluated for cell viability using MTT assay. Each tissue insert was transferred to a well containing 300 μL MTT (1mg/mL) solution in a 24-well plate and tissues were incubated for 3 ± 0.1 hr at standard cell culture conditions. - Number of replicates:
- 3 replicates
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of 3 replicates (3 minute)
- Value:
- 82.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of 3 replicates (60 minutes)
- Value:
- 36.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- In the corrosion assay, the positive control (KOH) reduced the relative mean tissue viability to 19.8% and 11.2%, following 3 and 60 minute exposures, respectively. The positive control results demonstrated appropriate study conduct and tissue responsiveness.
Assessment of Direct Test Material Reduction of MTT:
One limitation of this assay method is a possible interference of the test material with the MTT assay. A colored test substance or one that directly reduces MTT (and thereby mimics dehydrogenase activity of the cellular mitochondria) may interfere with the MTT end point. To assess potential direct test material reduction, 50 μL of methacryloxyisopropyl acid phthalate was incubated with 1 mg/mL of the MTT reagent at standard cell culture conditions for 60 min. Untreated (no test material) MTT medium was used as the negative control.
Results from this experiment suggested no direct reduction of MTT dye by methacryloxyisopropyl acid phthalate, as the test material did not turn the MTT solution to a blue/purple color.
Assessment of Test Material Color Interference:
Potential color interference can arise from colored test chemicals or test chemicals that become colored when in contact with water (environment during exposure) and/or isopropanol (extracting solution). To assess the potential of color interference, 50 μL of methacryloxyisopropyl acid phthalate was incubated with 300 μL of H2O at standard cell culture conditions for 60 min. Untreated (no test material) H2O was used as the negative control. As the solution was not colored at the end of the 60 min incubation, it can be concluded that the test material does not possess the potential to induce color interference.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean tissue viabilities of methacryloxyisopropyl acid phthalate-dosed tissues following the 3 minute exposure period was 82.1% and following the one hour exposure period was 36.5%. Since the mean tissue viability was > 50% at the 3 minute exposure and >15% at the 60 minute exposure, methacryloxyisopropyl acid phthalate was interpreted as a non-corrosive (NC) in the EpiDerm corrosion assay.
- Executive summary:
Methacryloxyisopropyl acid phthalate was evaluated for skin corrosion and irritation potential in in vitro EpiDerm skin corrosion and irritation assays (MatTek Corporation; Ashland, MA). The EpiDerm tissue model consists of normal, human-derived epidermal keratinocytes that are cultured to form a stratified, squamous epithelium similar to that found in human epidermis tissue. To assess corrosion potential, methacryloxyisopropyl acid phthalate was topically applied to the EpiDerm tissue for 3 and 60 minutes. In this study, sterile water and 8N potassium hydroxide (KOH) served as the negative and positive controls, respectively. At the end of exposure, cell viability in treated and control tissues were measured using the MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide) assay. The test substance is considered corrosive (UN GHS Corrosive) if the relative mean viability is ≤ 50% at three minutes or ≥ 50% at three minutes but less than 15% at one hour.
In the corrosion assay, the mean tissue viability of the positive control (KOH) following the 3 minute and 60 minute exposures were 19.8% and 11.2%, respectively, thereby demonstrating appropriate assay responsiveness. The mean tissue viabilities of methacryloxyisopropyl acid phthalate-dosed tissues following the 3 minute and 60 minute exposures were 82.1% and 36.5%, respectively. Therefore, under these conditions, methacryloxyisopropyl acid phthalate was interpreted as negative for corrosion potential in the EpiDerm corrosion assay (UN GHS Non-Corrosive).
Therefore, under the conditions of the EpiDerm corrosion study, methacryloxyisopropyl acid phthalate is predicted to be negative for dermal corrosion potential.
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