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EC number: 269-041-1 | CAS number: 68186-45-8
- 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:
- From May 16, 2017 to June 15, 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:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phosphoric acid, decyl octyl ester
- EC Number:
- 269-041-1
- EC Name:
- Phosphoric acid, decyl octyl ester
- Cas Number:
- 68186-45-8
- Molecular formula:
- C18H39O4P1 (representative: R = C8 and R1 = C10)
- IUPAC Name:
- Phosphoric acid, decyl octyl ester
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Supplier batch/lot No.: 0001146459; Appearance: colourless pale yellow liquid
In vitro test system
- Test system:
- human skin model
- Remarks:
- The reconstructed human epidermal model EpidermTM (EPI-200 MatTek Corporation)
- Cell type:
- other: normal human-derived epidermal keratinocytes
- Justification for test system used:
- The EpiDermTM skin model and assay for skin corrosion testing is endorsed by OECD TG 431.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Test system:
The reconstructed human epidermal model EpidermTM (EPI-200 MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differential model of the human epidermis. It consists of organised 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.
Characterisation of the test system:
MatTek’s EpiDermTM model has been extensively characterised for multiple parameters including morphology, tissue viability, skin barrier function and sterility. QC results for the specific lot of models received (Lot# 25819) were checked in-house for MatTek acceptance ranges with the following outcome:
- Morphology - PASS
- Tissue viability - PASS
- Skin barrier function (ET50 value for 1 % Triton X-100) where ET50 is the time taken for 1 % Triton X-100 to reduce the viability of the skin model to 50 % relative to the negative control) - PASS
- Sterility testing showed no contamination during long term antibiotic and antimycotic free culture - PASS - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 μl of neat test substance
- Duration of treatment / exposure:
- 3 and 60 minutes at 37 °C, 5 % CO2, 95 % RH
- Number of replicates:
- 3 replicates for test substance, negative and positive controls
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- 16.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- 4.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - Prior to the assay, the test substance was checked for interference (water coloration or MTT interference) and found not to interfere.
- The test substance did reduce the viability below 50 % after 3 min and below 15 % after 1 h and should be considered as corrosive.
All acceptance criteria were met:
- The mean OD570 of the negative control tissues must be ≥0.8.
Result: 1.651 after 3 min, 1.869 after 1 h
- The mean of the positive control relative percentage viability, after 1 hour exposure must be <15 % of the mean of the negative control.
Result: 3.0 %
- In the range between 20 % and 100 % viability, the coefficient of variation (CV) is an additional acceptance criterion. It should not exceed 0.3 (i.e 30 %).
Results:
NC: 5.6 % after 3 min, 5.6 % after 1 h
PC: 22.8 % after 3 min, 15.0 % after 1 h
Test substance: 13.2 % after 3 min, 7.6 % after 1 h
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1A (corrosive) based on CLP criteria
- Conclusions:
- Under the study conditions, the test substance was determined to be skin corrosive, sub category 1A.
- Executive summary:
An in vitro study was conducted to determine the skin corrosion potential of the test substance, mono- and di- C8-10 PSE, using the Reconstructed Human Epidermis (RHE) Test Method, according to OECD Guideline 431, in compliance with GLP. Three tissues of the human skin model EpiDermTM were used per treatment with the test substance, positive and negative control. 50 µL of the neat test substance was topically applied on each tissue model. Demineralised water was used as negative control, and KOH as positive control. After 3 minutes and 1 h treatment, the test substance or the control substance was rinsed off from the tissues. Then, cell viability of the tissues was evaluated by addition of MTT. Results were compared to negative control. All validity criteria for the performed test were met. After 3 minutes and 1 h treatment, the mean viability values obtained with the test substance were determined to be 16.5% and 4.4%. The test substance did reduce the viability below 50% after 3 min and below 15% after 1 hour and should be considered as corrosive. Under the study conditions, the test substance was determined to be skin corrosive (XcellR8, 2017).
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