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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 05 Aug - 02 Sep 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted Sep 2014
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, 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: Cool and dark place- Stability: 1 year
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm™ (EPI-200)
- Source strain:
- other: Keratinocyte strain 00267
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE- Model used: EpiDerm™ (EPI-200-SCT) (MatTek Corporation, Bratislava, Slovakia)- Tissue batch number(s): 21691- Shipping date: 2 Sept 2015 - Delivery date: 2 Sept 2015- Date of initiation of testing: 2 Sep 2015TEMPERATURE USED FOR TEST SYSTEM- Temperature used during treatment / exposure: 37 °CREMOVAL OF TEST MATERIAL AND CONTROLS-Volume and number of washing steps: The test item was carefully washed from the skin surface with Dulbecco's phosphate buffered saline (D-PBS)MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE- MTT concentration: 1 mg/mL- Incubation time: 3 h- Spectrophotometer: Tecan Sunrise Magellan Version 6.4 (Tecan Deutschland GmbH, Crailsheim, Germany)- Wavelength: 540 nmFUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA- Viability: The quality of the EpiDerm™ tissue was assessed by an 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 1% Triton X-100. The ET-50 value was determined to be 4.91 h.- Contamination: All biological components of the epidermis and the culture medium were tested by the manufacturer for viral, bacterial, fungal and mycoplasma contamination.NUMBER OF REPLICATE TISSUES: Duplicate tissues; from each tissue, 3 absorbance measurements after MTT incubation were performed.CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCEThe test substance did not directly reduce the MTT solution.PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL- Amounts applied: 50 µLNEGATIVE CONTROL- Amounts applied: 50 µLPOSITIVE CONTROL- Amounts applied: 50 µL- Concentration: 8.0 N
- Duration of treatment / exposure:
- 3 and 60 min
- Number of replicates:
- Duplicate tissues; from each tissue, 3 absorbance measurements after MTT incubation were performed.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 3 min exposure
- Value:
- 79.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 60 min exposure
- Value:
- 73.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:- Direct-MTT reduction: The test substance did not interfere with the MTT assay (no reducing capacity).ACCEPTANCE OF RESULTS: - Acceptance criteria met for negative control: The mean negative control OD, both for the 3 and 60 min exposure period, was in the range of ≥ 0.8 and ≤ 2.8.- Acceptance criteria met for positive control: Exposure to the positive control induced a decrease in the relative cell viability as compared to the negative control, both for the 3 min exposure period (7.1%) and for the 60 min exposure period (5.4%) thus the values were below the cut-off value at 60 min exposure confirming the validity of the test system and the specific batch of tissue models.- Acceptance criteria met for variability between replicate measurements: The SD of all replicates determined was below the limit of acceptance of 30%.- Range of historical values if different from the ones specified in the test guideline: the results of the negative and positive control fell within the historical control range (see Table 1 under "Any other information on results incl. tables").
Any other information on results incl. tables
Table 1: Historical data of negative and positive controls
Material | Criteria | Average viability (%) | OD (mean±SD) | Range of OD | Coefficient of variation (%) | ||||
3 min | 60 min | 3 min | 60 min | 3 min | 60 min | 3 min | 60 min | ||
Negative control | Non-corrosive | 100 | 100 | 1.78± 0.40 | 1.82± 0.52 | 1.10 - 2.29 | 1.02 - 2.42 | 22.2 | 28.7 |
8 N KOH | Corrosive | 10.0 | 5.0 | 0.18± 0.09 | 0.09± 0.03 | 0.03 - 0.33 | 0.04 - 0.13 | 50.5 | 38.6 |
OD = Optical Density
Table 2: Results after treatment with the test substance and controls
Test group | OD (n = 2 tissues) | SD | % OD540compared to the control % viability | OD (n = 2 tissues) | SD | % OD540compared to the control % viability |
3 min | 60 min | |||||
Negative control | 1.573 | 0.185 | 100 | 1.507 | 0.035 | 100 |
Test substance | 1.251 | 0.061 | 79.5 | 1.112 | 0.252 | 73.8 |
Positive control | 0.111 | 0.10 | 7.1 | 0.082 | 0.006 | 5.4 |
Applicant's summary and conclusion
- Interpretation of results:
- other: the results of this study as a stand-alone study are not suitable 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 RHE test method the test substance showed no corrosive properties.
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