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EC number: 701-116-0 | CAS number: 2156592-45-7
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (Z)-4-[C11-13 (branched) alkylamino]-4-oxo-2-butenoic acid
- EC Number:
- 701-116-0
- Cas Number:
- 2156592-45-7
- Molecular formula:
- C17H31NO3
- IUPAC Name:
- (Z)-4-[C11-13 (branched) alkylamino]-4-oxo-2-butenoic acid
Constituent 1
Test animals
- Species:
- other: not applicable, in vitro system
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized 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. The EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and are commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.
It was concluded by the ECVAM Scientific Advisory Committee that the EpiDerm™ human epidermis model is suitable to be used for distinguishing between corrosive and non-corrosive chemicals (ECVAM: ESAC statement on the application of the EpidermTM human skin model for skin corrosivity testing of 14-15 Mar 2000) as well as between irritant and non-irritant chemicals (ECVAM: ESAC statement on the scientific validity of in-vitro tests for skin irritation testing of 5 Nov )
Test system
- Type of coverage:
- other: N/A
- Preparation of test site:
- other: N/A
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: PC and NC were concurrently applied
- Amount / concentration applied:
- Corrosion Test: Fifty microliter (50 μL) of the undiluted liquid test substance, negative control (NC, water) or positive control (PC, 8 n potassium hydroxide)
Irritation Test: Thirty microliter (30 μL) of the undiluted liquid test substance, NC (PBS) or PC (5% SDS) - Duration of treatment / exposure:
- Corrosion Test: 3 min or 1 hr
Irritation Test: 1 hr (25 min at RT under the laminar flow hood and 35 min in the incubator) - Observation period:
- Corrosion Test: Tissues were immediately washed after incubation time with PBS
Irritation Test: 42 hrs ± 2 hrs - Number of animals:
- Corrosion Test: 2 tissues per exposure time (3 min at RT or 1 hr in the incubator) and test group (test material, NC, PC; 12 tissues per test)
Irritation Test: 3 tissues per test group - Details on study design:
- Corrosion Test:
From the day of arrival in the laboratory, tissues were kept in the refrigerator. At least 1 hour but not more than 1.5 hours before test-substance application, tissues were transferred to 6- well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C. The preincubation medium was replaced with fresh medium immediately before application of 50 µl of the test substance or controls. The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application treatment. Rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours. After incubation, tissues were washed with PBS and the formazan produced by the tissues was extracted with isopropanol. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 6 microtiter wells filled with isopropanol for each microtiter plate.
Irritation Test:
On the day of arrival in the laboratory, the tissues were transferred to sterile 6-well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C. After 1 hour the preincubation medium was replaced with fresh medium and preconditioning continued for 18 ± 3 hours. 30 µL of test material or controls were applied and tissues washed with sterile PBS to remove residual test material 1 hour after start of application. Rinsed tissues were blotted on sterile absorbent paper and transferred into new 6-well plates, pre-filled with 0.9 mL fresh medium. When all tissues were rinsed, the
surface of each tissue was carefully dried with a sterile cotton swab. Subsequently, the tissues were incubated in the incubator at 37°C for 24 ± 2 hours. After 24 ± 2 hours the tissues were transferred into new 6-well plates pre-filled with 0.9 mL of fresh medium and placed into the incubator for additional 18 ± 2 hours post-incubation period. After the post-incubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 6 microtiter wells filled with isopropanol for each microtiter plate.
The quotient of the OD570 of tissues treated with the test material and the mean OD570 values of the NC (percent of control) is used for evaluating whether or not a test material is corrosive or irritant. A test item is considered to be corrosive if the mean tissue viability (% of negative control) is < 50% after 3 min or >=50% after 3 min, but < 15% after 1 hr. Irritant potential of the test materials is predicted from the mean relative tissue viabilities
compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: corrosion test
- Value:
- 98
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 min. Max. score: 100.0. Reversibility: other: N/A. (migrated information)
- Irritation / corrosion parameter:
- other: other: corrosion test
- Value:
- 82
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 hr. Max. score: 100.0. Reversibility: other: N/A. Remarks: Corrosion test: Mean tissue viability (% of negative control): 3 min: < 50 = corrosive; 3 min: ≥ 50 and 1 hour: < 15 = corrosive; 3 min: ≥ 50 and 1 hour: ≥ 15 = non-corrosive . (migrated information)
- Irritation / corrosion parameter:
- other: other: Irritation test
- Value:
- 5
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 hr. Max. score: 100.0. Reversibility: other: N/A. Remarks: Irritation test: Mean tissue viability (% of negative control) ≤ 50 = irritant; > 50 = non-irritant . (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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