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EC number: 299-434-3 | CAS number: 93882-40-7
- 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:
- 7th August 2014 - 17th September 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate
- EC Number:
- 299-434-3
- EC Name:
- 4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate
- Cas Number:
- 93882-40-7
- Molecular formula:
- C48H86O8S
- IUPAC Name:
- 2-octadecenylsuccinic anhydride, thiodiethanol esterification products
- Test material form:
- solid
- Remarks:
- Waxy Solid
1
- Specific details on test material used for the study:
- Lot Number 00031-353/ E00298-234-001
Physical State: Brown Solid
Sotrage Conditions: Ambient Temerpature in the dark, sealed container
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek
- Justification for test system used:
- The EpiDerm™ model closely mimics the human epidermis and thus provides an important in vitro approach in the evaluation of dermal corrosion and toxicity.
- Vehicle:
- water
- Details on test system:
- The 3-dimensional Human Dermal Epithelial Model (EpiDerm™, MatTek Corp., Ashland, MA) is made up of normal human keratinocytes in serum free medium. The cells form an epithelial tissue that consists of organized basal, spinous, granular, and cornified layers analogous to those found in vivo. The EpiDerm™ model also contains epidermis-specific differentiation markers such as profilaggrin, the K1/K10 cytokeratin pair, involucrin, and type I epidermal transglutaminase, as well as keratohyalin granules, tonofilament bundles, desmosomes, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns characteristic of in vivo epidermis. This model has been used with several common tests of cytotoxicity, corrosion and irritation including 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT), release of lactate dehydrogenase (LDH), expression and release of interleukin 1-alpha (IL-1a), release of prostaglandin E2 (PGE2) and sodium fluorescein permeability. A growing body of evidence indicates that EpiDerm™ effectively provides a non-animal means to assess dermal corrosion and other toxicological issues.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of test article
- Duration of treatment / exposure:
- 3 minutes at room temperature and 60 minutes at approximately 37°C, approximately 5% CO2 in a humidified incubator.
- Duration of post-treatment incubation (if applicable):
- The MTT assay was performed by transferring the tissues to 24- well plates containing 300 µL MTT medium (1.0 mg/mL). After 3 hours MTT incubation at approximately 37°C, approximately 5% CO2 in a humidified incubator, the tissues were rinsed
twice with DPBS. The blue formazan salt was extracted by submerging tissues in 2 mL isopropanol in a 24-well plate. The extraction time was overnight protected from light, followed by a 15 minute shaking period the following day. - Number of replicates:
- n=6
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 Minute Mean
- Value:
- ca. 107.9
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 30.6
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute Mean
- Value:
- ca. 81.2
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 5.7
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Negative Control (NC)
The assay meets the acceptance criterion if the Optical Density (OD570) of the NC tissues (treated with sterile ultrapure water) in the MTT assay is =0.8 and =2.8. This is an indicator of tissue viability following shipping and conditions under use. In this assay, the acceptance
criterion was met with each negative control OD between 1.870 and 2.798.
Positive Control (PC)
8N KOH (potassium hydroxide) was used as a PC and tested concurrently with the test article. The assay is meeting the acceptance criteria if the mean viability of the positive control after 1 hour exposure, expressed as mean % of the negative control, is <15%. In this
assay, this acceptance criterion was met with mean % viability of 5.7% viable after 1 hour exposure, resulting in the classification as a corrosive.
Tested Samples
The assay is meeting the acceptance criteria if the tested samples, when in the range of 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates is =30%. This is an indicator of tissue reproducibility and proper performance of the assay. In this assay, this
acceptance criterion was met with a percent CV of 7.7% and 7.8% for the 3 minute and 1 hour exposures, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Substance was demonstrated to be non-corrosive in vitro corrosion assay.
- Executive summary:
The MatTek EpiDerm™ model was used to assess the potential dermal corrosivity of a test article by determining the cell viability of the tissues after exposure to the test article. The pre-testing (color and MTT pre-test) was performed on August 20, 2014 while the dosing and MTT assay were performed on August 26th. The objective of this study was to assess the dermal corrosion potential of the test article. Tissues were exposed to the test article and controls for three minutes and one hour. The viability of each tissue was determined by MTT assay. The positive control, 8N potassium hydroxide (KOH), reduced cell viability to 30.6% of control after 3 minute exposure and to 5.7 of control after 1 hour exposure. The test article had no effect on the cell viability after 3 minutes exposure (>100% viable) and only a mild effect at 60 minutes exposure (>81% viable). These data suggest that the test material is non-corrosive according to the OECD test guideline using MatTek EpiDerm™ tissues.
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