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EC number: 287-673-6 | CAS number: 85566-63-8
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 October 2017 - 26 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- yes
Test material
- Reference substance name:
- Dioctyl maleate, branched
- EC Number:
- 287-673-6
- EC Name:
- Dioctyl maleate, branched
- Cas Number:
- 85566-63-8
- Molecular formula:
- C20H36O4
- IUPAC Name:
- 1,4-bis(octan-2-yl) (2Z)-but-2-enedioate
Constituent 1
- Specific details on test material used for the study:
- Test Article: Bernel Ester DCM
CAS Number: 85566-63-8
Storage: 15 to 25˚C, protected from light
Purity: 92.78%
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Three-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum supplied by MatTek In Vitro Life Science Laboratories, Bratislava, Slovak Republic.
- Justification for test system used:
- This study was conducted to determine whether the test article causes corrosion in the in vitro skin model EpiDermTM.
The test article was applied topically to a three-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum. Corrosive materials are identified by their ability to produce a decrease in cell viability (as determined using the MTT reduction assay) below defined thresholds at specified exposure periods. The principle of the human skin model assay is based on the hypothesis that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion, and are cytotoxic to the underlying cell layers. - 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 supplied by MatTek In Vitro Life Science Laboratories, Bratislava, Slovak Republic.
Identification
The test system was appropriately labelled with the study number, date of treatment, duration of treatment and negative/positive/test article.
General Model 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.
Functional Model Conditions
The magnitude of viability is quantified using MTT. The optical density (OD) of the extracted (solubilised) dye from the negative control tissue is at least 20-fold greater than the OD of the extraction solvent alone. The negative control tissue has been shown to be stable in culture for the duration of the test exposure period. The stratum corneum is sufficiently robust to resist the rapid penetration of certain cytotoxic marker chemicals (eg 1% Triton X-100). This property has been estimated by the exposure time required to reduce cell viability by 50% (ET50). For the EpiDermTM model the lower acceptance limit is 4.08 hours and the upper acceptance limit is 8.7 hours. The tissue has been shown to demonstrate reproducibility over time, and it has been shown to be capable of predicting the corrosive potential of the reference chemicals when using the testing protocol selected. - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 3 minute and 60 minutes
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 4
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes exposure
- Value:
- 98
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes exposure
- Value:
- 93
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The OD values for the negative controls met the acceptance criteria.
Skin viability after a 3 minute or 60 minute exposure to the positive control article was 2% and 4%, respectively, demonstrating appropriate performance of the assay.
Any other information on results incl. tables
3 minute exposure period
Test Substance | OD570 | Mean | Tissue Mean | Tissue Mean - FK | %Survival | %CV | ||
Negative | 0.968 | 0.981 | 0.969 | 0.973 | 1.029 | 100 | 6.1 | |
Negative | 1.066 | 1.105 | 1.082 | 1.084 | ||||
Test article | 1.021 | 1.031 | 1.017 | 1.023 | 1.009 | 98 | 1.8 | |
Test article | 0.982 | 1.005 | 0.997 | 0.995 | ||||
Positive | 0.192 | 0.191 | 0.189 | 0.191 | 0.175 | 0.018 | 2 | 9.6 |
Positive | 0.16 | 0.162 | 0.158 | 0.16 | ||||
Positive FK | 0.131 | 0.132 | 0.13 | 0.131 | 0.158 | |||
Positive FK | 0.183 | 0.186 | 0.184 | 0.184 |
60 minute exposure period
Test Substance | OD570 | Mean | Tissue Mean | Tissue Mean - FK | %Survival | %CV | ||
Negative | 1.174 | 1.19 | 1.168 | 1.177 | 1.166 | 100 | 1.7 | |
Negative | 1.156 | 1.133 | 1.172 | 1.154 | ||||
Test article | 1.102 | 1.047 | 1.103 | 1.084 | 1.082 | 93 | 2 | |
Test article | 1.08 | 1.091 | 1.068 | 1.079 | ||||
Positive | 0.308 | 0.296 | 0.31 | 0.305 | 0.259 | 0.05 | 4 | 20 |
Positive | 0.202 | 0.236 | 0.202 | 0.213 | ||||
Positive FK | 0.211 | 0.25 | 0.217 | 0.226 | 0.21 | |||
Positive FK | 0.193 | 0.191 | 0.197 | 0.194 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article, Bernal Ester DCM, was considered to be non-corrosive according to the UN GHS classification system.
- Executive summary:
This study was conducted to determine whether the test article, Bernel Ester DCM, causes corrosion in the in vitro skin model EpiDermTM.
Duplicate EpiDermTM inserts were treated with test article, purified water (negative control) and 8N potassium hydroxide (positive control) for 3 minutes and 60 minutes. At the end of the treatment period, the tissues were washed with phosphate buffered saline (PBS) and cell viability was assessed using the MTT assay. The skin corrosivity potential was classified according to the remaining cell viability obtained after test material treatment with either of the two treatment times.
Skin viability after a 3 minute or 60 minute exposure to the test article was 98% and 93%, respectively.
The OD values for the negative controls met the acceptance criteria.
Skin viability after a 3 minute or 60 minute exposure to the positive control article was 2% and 4%, respectively, demonstrating appropriate performance of the assay.
The test article, Bernal Ester DCM, was considered to be non-corrosive according to the UN GHS classification system.
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