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EC number: 700-840-4 | CAS number: 160583-22-2
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is comparable to a guideline study with adaptions that do not impair the overall conclusion from data. The applied tissue model and test protocol was tested in a catch-up validation study and validation results are currently asessed at EURL-ECVAM with the aim of official regulatory acceptance. Accordingly, the study follows the prediction model as described in the EURL-ECVAM "Performance Standards for in vitro Skin Irritation Testing" (ECVAM 2009). The study was carried out with reference to selected rules of GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Study was performed with the Henkel OS-REp (Open Source Reconstructed Epidermis Model) model according to the Standard Operation Procedure “Catch-up Validation Study Skin Irritation: Open Source Epidermal Model; Version 3.2; revised October 2011”.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-phenylethyl 2-cyanoprop-2-enoate
- EC Number:
- 700-840-4
- Cas Number:
- 160583-22-2
- Molecular formula:
- C12 H11 N O2
- IUPAC Name:
- 2-phenylethyl 2-cyanoprop-2-enoate
- Reference substance name:
- [TN]PhECA[/TN][SPEC][/SPEC][AM] > 98.8 % [/AM]
- IUPAC Name:
- [TN]PhECA[/TN][SPEC][/SPEC][AM] > 98.8 % [/AM]
- Test material form:
- solid: crystalline
- Details on test material:
- 2-Phenylethyl cyanoacrylate, Batch 3635-59, > 98.8 %
Constituent 1
Constituent 2
Test animals
- Species:
- other: Human Skin Model
- Strain:
- other: OS-REp reconstituted epidermis model
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistured with PBS
- Controls:
- other: not applicable
- Amount / concentration applied:
- ~31 µg/cm² (substabce was applied with a 25 µl spoon for the sake of practicability, see details on study design)
- Duration of treatment / exposure:
- 0,5 h
- Observation period:
- 42 h
- Number of animals:
- 0
- Details on study design:
- Test substance:
For application of the test substance, a sharp application spoon with a volume of 25 µl was used. The spoon was filled and excess material gently scratched away without applying any pressure. The material was distributed evenly over the surface of the skin models and moistured with 25 µl PBS. The application time started after applying PBS.
Negative control:
Phosphate buffered saline, pH 7.0-7.4, with Ca/Mg (D-PBS). 25 µl of the negative control were directly dispensed atop the tissue surface. Based on historical data, the mean OD at 590 nm in the MTT assay with models treated with PBS should be located between 0.8 and 1.5 relative units.
Positive control:
5% (aq) sodium dodecyl sulphate (CAS 151-21-3). 25 µl of the postive control were directly dispensed atop the tissue surface. Viability of skin models treated with the positive control should be below 10 % based on historical data.
Treatment and MTT assay:
At the day of substance testing the OS-REp models were transferred from petri dishes to the wells of 6-well plates, where they were provided with 1 ml of fresh prewarmed culture medium each. The models were then topically exposed to the chemicals for 35 minutes each. Three tissues were used for the 2-phenylethyl cyanoacrylate, positive control (PC) and negative control (NC). After the indicated period of time the tissues were thoroughly washed with buffer solution and transferred to fresh prewarmed culture medium. After 42 hours of incubation at 37°C the tissues were transferred to 24 well-plates containing 0.2 ml of a freshly prepared MTT solution (1 mg/ml), where they remained for 3 hours. Then the blue formazan dye, which has been deposited inside living cells, was extracted with 2 ml of 2-propanol each for 2 hours at ambient temperature. The optical density of the extracted formazan solution was determined in a spectrophotometer at a wavelength 570 nm without reference wavelenght. The relative cell viability was calculated for each tissue as the percentage of the mean negative control tissues.
Data evaluation and statistical procedure:
According to the GHS classification the irritation potential for a test substance is predicted if the mean relative tissue viability of three individual tissue exposed to said substance is reduced below or equal to the 50% threshold of the mean viability of the negative controls.
In vitro result: In vivo prediction:
Mean tissue viability ≤ 50% of NC Irritant
Mean tissue viability > 50% of NC Non-irritant
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Viability human skin model
- Value:
- ca. 97
- Remarks on result:
- other:
- Remarks:
- Basis: other: not applicable. Time point: 42 h. Max. score: 100.0. Reversibility: other: not applicable. Remarks: score is tissue viability as percentage of negative control. (migrated information)
Any other information on results incl. tables
All OS-REp models treated with the test substance and the controls could be included into the data analysis process. The table depicts the relative viabilities of the OS-REp models topically treated with 2 -phenylethyl cyanoacrylate and the controls. The test substance did not significantly decrease the relative tissue viability. With 97.3% the mean value is similar to that of the negative control. According to the prediction model 2 -phenylethyl cyanoacrylate can be regarded as non-irritating to the skin.
Table: Mean relative viability data of the OS-REp models after topical application of the indicated substances (mean ± SD). Viability has been determined after 35 minutes substance exposure time and 42 hours of post-incubation. All data are calculated compared to the negative control (= 100% rel. viability)
Test substance |
Mean rel. viability |
SD |
Negative control |
100.00 |
8.52 |
Positive control |
1.33 |
0.47 |
2-Phenylethyl cyanoacrylate |
97.28 |
10.87 |
Quality criteria:
- The the mean optical density of the negative control was 1,214 +/- 0,103 absorption units.
- The positive control (5% SDS solution) killed the tissue models nearly completely, resulting in a remaining activity of 1.33 +/- 0.47%
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the test results, 2-phenylethyl cyanoacrylate is classified as being non-irritant in the in vitro skin irritation test under the described experimental conditions.
- Executive summary:
2 -Phenylethyl cyanoacrylate (PhECA) was tested for skin irritation on a human three dimensional epidermal model (OS-REp, Henkel). PhECA were applied topically with the help of a 25 µl spoon to the skin model, moistened with PBS and applied for 35 minutes before the substance was washed away from the models. Application was followed by a 42 hours incubation period, then the cytotoxic (irritancy) effect was determined. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after treatment with PhECA was 85% compared to the negative control tissues. Since the mean relative tissue viability for PhECA was above 50% it is considered to be non irritant. The positive control (SDS) had a mean cell viability of about 1 %. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was 1.2. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.
Finally, it is concluded that this test is valid and that PhECA is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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