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EC number: 680-798-0 | CAS number: 886577-76-0
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Feb - 17 Mar 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted Jul 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
- Reference substance name:
- 2-isocyanato-2-methyl-3-(prop-2-enoyloxy)propyl prop-2-enoate
- Cas Number:
- 886577-76-0
- Molecular formula:
- C11H13NO5
- IUPAC Name:
- 2-isocyanato-2-methyl-3-(prop-2-enoyloxy)propyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: At room temperature
Test animals / tissue source
- Species:
- human
- Strain:
- other: EpiOcular™
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL - Amounts applied: 50 µL NEGATIVE CONTROL - Amounts applied: 50 µLPOSITIVE CONTROL - Amounts applied: 50 µL
- Duration of treatment / exposure:
- 30 min
- Duration of post- treatment incubation (in vitro):
- 120 min
- Number of animals or in vitro replicates:
- duplicates for each treatment and control group; from each tissue, 2 absorbance measurements after MTT incubation were performed.
- Details on study design:
- - RhCE tissue construct used, including batch number: EpiOcular™ tissue (MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia), batch number: 23701- Viability: The quality of the final tissue was assessed by undertaking a MTT cell viability test.- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 µL of 0.3% Triton X-100. The ET-50 value was determined to be 15.18 min.- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods: 30 min exposure, 12 min post-exposure immersion and 120 min post-exposure incubation at 37 °C- Indication of controls used for direct MTT-reducers and/or colouring test chemicals: The ability of the test substance to directly reduce MTT and to form a blue/purple reaction product was assessed in a pre-experiment. Since the MTT solution colour did not turn blue/purple, the test substance is not presumed to have reduced the MTT. An additional test with freeze-killed tissues was not to be required.- Number of tissue replicates used per test chemical and controls: 2- Wavelength: 570 nm- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model: If the test item-treated tissue viability is > 60% relative to the negative control treated tissue viability, the test item is labelled non-irritant. If the test item-treated tissue viability is ≤ 60% relative to negative control treated tissue viability, the test item is labelled irritant.- Reference to historical data of the RhCE tissue construct: Historical control data was used to assess the validity of the test.- Acceptance criteria:The results are acceptable if:- The negative control OD is > 0.8 and < 2.5, - The mean relative viability of the positive control is below 50% of the negative control viability. - The difference of viability between the two relating tissues of a single test item is < 20% in the same run (for positive and negative control tissues and tissues of test items). This applies also to the killed controls (items and negative killed control) and the colorant controls which are calculated as percent values related to the viability of the relating negative control. This applies also to the killed controls (single items and negative killed control) which are calculated as percent values related to the viability of the relating negative control.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % tissue viability mean value of 2 tissues
- Run / experiment:
- 30 min exposure
- Value:
- 52.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER OBSERVATIONS:The optical pre-experiment (colour interference pre-experiment) to investigate the colour change potential of the test substance in water or isopropanol did not led to a change in colour. Optical evaluation of the MTT-reducing capacity of the test substance with MTT-reagent did not show blue colour.ACCEPTANCE OF RESULTS:- Acceptance criteria met for negative control: The negative control values were between 1.903 and 2.290.- Acceptance criteria met for positive control: Treatment with the positive control induced a decrease in the mean relative absorbance to 24.2%, compared with the negative control, thus the validity of the test system is ensured. - Acceptance criteria met for viability: The difference in mean viability between 2 duplicate tissues during the same run was 4.6-6.9%, for the positive control tissues, the negative control tissues and the test substance tissues. Please refer to Table 2 under "Any other informational results incl. Tables".
Any other information on results incl. tables
Table 1: Historical Control Data
Positive Control | Negative Control | |
Mean Viability | 32.0% | |
Rel. Standard Deviation | 12.8% | |
Range of Viabilities | 6.90 - 40.4% | |
Mean Absorption | 0.538 | 1.65 |
Rel. Standard Deviation | 0.258 | 0.299 |
Range of Absorbance | 0.107 - 0.849 | 1.27 - 2.05 |
Data of 11 studies performed from July 2015 until end of February 2016
Table 2: Results after treatment for 30 min with the test substance and the controls
Test Group | Absorbance 570 nm Well 1 | Absorbance 570 nm Well 2 | Mean Absorbance Tissue 1 and 2 | Mean Absorbance* Tissue 1 and 2 minus Mean Blank | Mean Absorbance of 2 Tissues* | Rel. Absorbance [%] Tissue 1 and 2** | Absolute Value of the Difference of the Rel. Absorbances [%] Tissue 1 and 2 | Rel. Absorbance [% of Negative Control]** |
Negative Control (Tissue 1 and 2) | 2.290 | 2.104 | 2.197 | 2.160 | 2.109 | 102.4 | 4.8 | 100.0 |
1.903 | 2.288 | 2.095 | 2.059 | 97.6 | ||||
Positive Control (Tissue 1 and 2) | 0.623 | 0.617 | 0.620 | 0.584 | 0.511 | 27.7 | 6.9 | 24.2 |
0.464 | 0.485 | 0.474 | 0.438 | 20.8 | ||||
Test Substance (Tissue 1 and 2) | 1.181 | 1.194 | 1.187 | 1.151 | 1.103 | 54.5 | 4.6 | 52.3 |
1.081 | 1.102 | 1.091 | 1.054 | 50.0 |
*: Mean of two replicate wells after blank correction
**: Relative absorbance (rounded values): 100 × (absorbance test substance/positive control) / (absorbance negative control)
Applicant's summary and conclusion
- Interpretation of results:
- other: the results of this study as a stand-alone study are not suit able for classification according to CLP/EU GHS criteria; the results may be used for classification purposes in a weight of evidence approach
- Conclusions:
- Under the conditions of the RhCE test method the test substance showed irritant properties.
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