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EC number: 226-029-0 | CAS number: 5232-99-5
- 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:
- 24 Jan 2012 - 08 Feb 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EU) No. 761/2009 of 23 July 2009 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology, BASF SE, 67056 Ludwigshafen, Germany
Test material
- Reference substance name:
- Etocrilene
- EC Number:
- 226-029-0
- EC Name:
- Etocrilene
- Cas Number:
- 5232-99-5
- Molecular formula:
- C18H15NO2
- IUPAC Name:
- ethyl 2-cyano-3,3-diphenylprop-2-enoate
- Test material form:
- solid
- Details on test material:
- - Physical state: solid/white
Constituent 1
Test animals
- Species:
- other: Reconstructed human epidermis model EpiDermTM
- Strain:
- other: Tissue model: Epi-200
- Details on test animals or test system and environmental conditions:
- Origin of tissue: MatTek Corporation, Ashland MA, USA
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: 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.
- Vehicle:
- other: The test substance was applied minimally moistened with PBS.
- Controls:
- other: Negative control (NC): PBS, sterile. Positive control (PC): 5% (w/v) sodium dodecyl sulfate (SDS, Sigma, Germany) in deionized water, sterile.
- Amount / concentration applied:
- 25 μL of the solid ground test material (about 20 mg) was applied with a sharp spoon.
- Duration of treatment / exposure:
- The tissues were kept under the laminar flow hood at room temperature for 25 minutes overall and for 35 minutes in the incubator.
- Observation period:
- 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.
- Number of animals:
- Three tissues were treated with the test substance, the PC and NC, respectively.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The tissues were washed with sterile PBS to remove residual test material 1 hour after start of application.
SCORING SYSTEM:
The present test is based on the experience that irritant chemicals produce cytotoxicity in human reconstructed epidermis. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow colored water-soluble 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) to the insoluble blue colored formazan.
After the postincubation 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.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 100
Any other information on results incl. tables
EXPERIMENTAL RESULTS
tissue 1 | tissue 2 | tissue 3 | mean | SD | ||
negative control | mean OD570 | 1.932 | 2.087 | 1.96 | 1.993 | |
viability [% of NC] |
96.9 | 104.7 | 98.3 | 100 | 4.15 | |
test material | mean OD570 | 1.958 | 2.046 | 1.959 | 1.988 | |
viability [% of NC] |
98.2 | 102.7 | 98.3 | 100 | 2.54 | |
positive control | mean OD570 | 0.13 | 0.126 | 0.13 | 0.129 | |
viability [% of NC] |
6.5 | 6.3 | 6.5 | 6 | 0.11 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the observed results and applying the evaluation criteria cited it was concluded, that the test substance does not show a skin irritation potential in the EpiDermTM skin irritation test under the test conditions chosen.
- Executive summary:
The potential of the test substance to cause dermal irritation was assessed by a single topical application of 25 μL bulk volume (about 20 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). Three EpiDerm™ tissue samples were incubated with the test substance for 1 hour followed by an about 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/ post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability. The EpiDerm skin irritation test showed the following results: The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 100%. Based on the observed results and applying the evaluation criteria cited it was concluded, that the test article does not show a skin irritation potential in the EpiDerm™ skin irritation test under the test conditions chosen.
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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