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EC number: 947-796-4 | 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 16, 2013 to July 22, 2013
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phosphoric acid, hexadecyl phosphate esters, potassium salts with cetostearyl alcohol
- Molecular formula:
- C16H34O4P1K1 (representative: mono- C16 PSE, K+) C16H34O1 (representative alcohol: C16 alcohol)
- IUPAC Name:
- Phosphoric acid, hexadecyl phosphate esters, potassium salts with cetostearyl alcohol
- Test material form:
- solid: granular
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- human three dimensional epidermal model (EPISKIN Small Model (EPISKIN-SMTM))
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The test is based on the experience that irritant chemicals show cytotoxic effects following short term exposure to the stratum corneum of the epidermis. The test was designed to predict and classify the skin irritation potential of a test substance by assessment of its effect on a three dimensional human epidermis model. In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- - Triplicates skin tissues were moistened with sterile distilled water and then treated with 10 mg test substance for 15 ± 0.5 minutes. Negative (PBS) and positive (SDS 5%) controls were included as well in the experiment. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment (optical density measurement). Skin irritation was expressed as the remaining cell viability after exposure to the test substance.
- Possible inflammatory mediator (IL-1a) was also determined. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 mg
- Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Expressed as the reduction of mitochondrial dehydrogenase activity
- Value:
- ca. 108
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100% relative mean viability
- Positive controls validity:
- valid
- Remarks:
- 19.5% relative mean viability
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - Skin irritation was expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test substance compared to the negative control tissues was 108.0%. Since the mean relative tissue viability for the test substance was above 50%, it was considered to be non-irritant. It was unnecessary to perform IL-1a analysis as the results of the MTT test were unequivocal.
- The positive control had a mean cell viability of 19.5% after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range.
- The standard deviation value of the percentage viability of three tissues treated identically was 2.0% or less, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified based on EU CLP criteria
- Conclusions:
- Under the study conditions, the test substance was determined to be non-irritating to the skin.
- Executive summary:
An in vitro study was conducted to determine the skin irritation potential of the test substance, 'mono- and di- C16 PSE, K+ and C16-18-OH', using Reconstructed Human Epidermis Test Method – EpiskinTM, according to OECD Guideline 439 and EU Method B.46, in compliance with GLP. Triplicates skin tissues were moistened with sterile distilled water and then treated with 10 mg test substance for 15 ± 0.5 minutes. Positive (5% Sodium Dodecyl Sulphate) and negative (Phosphate Buffered Saline Dulbecco's) controls were included in the experiment as well. After a 42 h post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment (optical density measurement). Skin irritation was expressed as the remaining cell viability after exposure to the test substance. Possible inflammatory mediator (IL-1a) was also determined. The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 108.0%. Since the mean relative tissue viability for the test substance was above 50%, it was considered to be non-irritant. It was unnecessary to perform IL-1a analysis as the results of the MTT test were unequivocal. The positive control had a mean cell viability of 19.5% after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was 2.0% or less, indicating that the test system functioned properly. The study was considered to have met all the validity criteria. Under the study conditions, the test substance was determined to be non-irritating to the skin (Harlan, 2014).
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