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Diss Factsheets
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EC number: 924-670-7 | CAS number: -
- 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:
- 02/06/2020 - 02/07/2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
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:
- 2019
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Polyurethane thickener
- IUPAC Name:
- Polyurethane thickener
Constituent 1
- Specific details on test material used for the study:
- - Direct MTT reduction: The test item was tested for the ability of direct MTT reduction. The MTT solution did not change its colour; therefore, direct MTT reduction had not taken place, and no data correction was necessary.
- Assessment of Coloured or Staining Test Items: After subtraction of the mean OD for isopropanol, the mean OD of the test item solution was 0.00 (≤ 0.08). Therefore, the main test was performed without colourant controls.
Test animals / tissue source
- Species:
- human
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability:
The EpiOcularTM Eye Irritation Test (EIT) predicts the acute eye hazard potential of chemicals by measurement of tissue damage caused by cytotoxic effects in the reconstructed human cornea-like tissue model.
- Description of the cell system used: The EpiOcularTM tissue consists of normal, human-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells. These cells are not transformed or transfected with genes to induce an extended life span. The EpiOcularTM tissues are cultured in specially prepared cell culture inserts with a porous membrane through which nutrients can pass to the cells. The tissue surface is 0.6 cm2.
- Cell line used, its source, batch number used for testing: EpiOcularTM tissues, MatTek In Vitro Life Science Laboratories, batch 30665
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- - Amount of test material and controls applied: 50 μL
- Duration of treatment / exposure:
- - Negative and positive controls: 28 minutes
- Test item: 30 minutes - Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- Duplicate
- Details on study design:
- - Details of the test procedure used
: MTT assay
- Doses of test chemical and control substances used
: 50 μL
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods: 50 μL of the controls and the test item were applied in duplicate in one- minute- intervals. After dosing the last tissue, the plates were transferred into the incubator for 28 minutes (negative and positive control) and 30 minutes (test item) at 37 ± 1°C, 5 ± 1 % CO2 and ≥ 95% relative humidity. At the end of the exposure time, tissues were rinsed with DPBS then immediately transferred to and immersed in 5 mL of pre-warmed assay medium for 12 minutes post soak at room temperature. For post-treatment incubation, the tissues were incubated in assay medium for 120 minutes at 37 ± 1°C, 5 ± 1 % CO2 and ≥ 95% relative humidity.
- Controls used for direct MTT-reducers and/or colouring test chemicals: Following pre-test checks, no controls for direct MTT-reduction or coloured test item was required.
- Number of tissue replicates used per test chemical and controls: Two
- Wavelength and band pass used for quantifying MTT formazan: Plate spectrophotometer at 570 nm
- Measurements: Optical density (OD)
- Calculation: % viability = (OD corrected of test item or positive control / OD corrected of mean negative control) x 100
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 1
- Value:
- 106.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 2
- Value:
- 103.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- Mean
- Value:
- 105.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE AND VALIDITY:
- Acceptance criteria met for negative control: Yes - OD value of 2.0 (i.e. >0.8 - < 2.0)
- Acceptance criteria met for positive control: Yes - mean relative viability value of 39.0% compared to negative control (i.e. <50%)
- Variation within replicates: 8.9% for the negative control, 5.3% for the positive control and 3.0% for the test item (i.e. <20%)
- Historical data: The values for negative control and for positive control were within the range of historical data of the test facility.
- Conclusion: The experiment is considered valid.
RESULTS AND CONCLUSION:
- Test results: After treatment with the test item, the mean value of relative tissue viability was increased to 105.2%. This value is above the threshold for eye irritation potential (≤ 60%). Therefore, under the conditions of the test, the test item is considered non-eye irritant in the EpiOcularTM Eye Irritation Test.
Any other information on results incl. tables
Table 1. Mean OD570 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item | OD570 of tissues | Individual tissue viability (%) | Relative mean viability (%) | Variation within replicates (%) |
Negative control | 2.119 | - | - | 8.9 |
1.939 | - | |||
Positive control | 0.845 | 41.6 | 39.0 | 5.3 |
0.738 | 36.4 | |||
Test item | 2.166 | 106.7 | 105.2 | 3.0 |
2.105 | 103.7 |
OD = Optical density
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test item is considered non-eye irritant in the EpiOcularTM Eye Irritation Test.
- Executive summary:
The in vitro eye irritation potential was tested in the Reconstructed Human EpiOcular™ Model (OECD 492). After treatment with the test item, the mean value of relative tissue viability was increased to 105.2%. This value is above the threshold for eye irritation potential (≤ 60%). Therefore, the test item is considered to be non-irritating and was classified as a non-irritant.
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