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Diss Factsheets
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EC number: 935-814-3 | CAS number: 1797437-47-8
- 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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: There is no OECD Test Guideline for this study, but it was conducted according to GLP and sufficient information is available for interpretation of results.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Assessment of ocular irritation potential done using the SkinEthic reconstructed human corneal epithelium model (10 minute exposure)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report)
- Physical state: White powder
- Analytical purity: 99.5%
- Storage condition of test material: Room temperature in the dark.
Constituent 1
Test animals / tissue source
- Species:
- other: SkinEthic reconstructed human corneal epithelium model
- Strain:
- other: SkinEthic reconstructed human corneal epithelium model
- Details on test animals or tissues and environmental conditions:
- The SkinEthic HCE model consists of transformed human corneal epithelial cells of the cell line HCE (LSU EYE Center, New Orleans, USA) that form a corneal epithelial tissue (mucosa), devoid of stratum, resembling, histologically, the mucosa of the human eye.
The test item is applied directly to the culture surface, at the air interface, so that undiluted and/or end use dilutions can be tested directly. The model consists of an airlifted, living, corneal tissue construct, produced in polycarbonate inserts in serum-free and chemically defined medium.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative and positive controls maintained
- Amount / concentration applied:
- 30 mg
- Duration of treatment / exposure:
- 10 minute
- Observation period (in vivo):
- 3 hours
- Number of animals or in vitro replicates:
- Reconstructed human corneal epithelium
- Details on study design:
- The experimental design of the study consists of a test for direct reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) by the test item followed by the main test.
For the main test, triplicate SkinEthic tissues were treated with 30mg of the test item for 10 minutes. Triplicate tissues treated with 30 microliter of solution A served as the negative control and triplicate tissues treated with 30 microliter of 2% sodium dodecyl sulphate (SDS) served as a positive control. At the end of the exposure period each SkinEthic tissue was rinsed. The rinsed tissues (two per group) were taken for MTT loading. The remaining tissues were retained for possible histopathology. Following MTT loading the reduced MTT was extracted from the tissues. After extraction the absorbency of triplicate aliquots of the extracted MTT solution for each SkinEthic tissue was measured. The optical density was measured at 540 nm. Data are presented in the form of percentage viability (MTT conversion relative to negative controls).
Results and discussion
In vivo
Results
- Irritation parameter:
- other: relative mean tissue viability
- Basis:
- mean
- Time point:
- other: 10 minute exposure period
- Max. score:
- 100.7
- Reversibility:
- other: Not applicable - In vitro testing
- Remarks on result:
- other: End point expressed as %
- Irritant / corrosive response data:
- The relative mean tissue viability of the test item treated tissues was 100.7% after a 10-minute exposure period.
The test item was classified according to the following criteria:
(1)If the percentage relative mean tissue viability was >60% the test item was considered to be non-irritant (NI)
(2)If the percentage relative mean tissue viability was <60% the test item was considered to be irritant (I) - Other effects:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The relative mean viability of the test item treated tissues after 10-minute exposure period was 100.7%.
The test item was considered to be Non-Irritant. - Executive summary:
The purpose of this test was to determine the eye irritation potential of the test item using the SkinEthic reconstructed Human Corneal Epithelium model (HCE, SkinEthic Laboratories, Nice, France) after a treatment period of 10 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death.
The experimental design of the study consists of a test for direct reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) by the test item followed by the main test.
For the main test, triplicate SkinEthic tissues were treated with 30mg of the test item for 10 minutes. Triplicate tissues treated with 30 microliter of solution A served as the negative control and triplicate tissues treated with 30 microliter of 2% sodium dodecyl sulphate (SDS) served as a positive control. At the end of the exposure period each SkinEthic tissue was rinsed. The rinsed tissues (two per group) were taken for MTT loading. The remaining tissues were retained for possible histopathology. Following MTT loading the reduced MTT was extracted from the tissues. After extraction the absorbency of triplicate aliquots of the extracted MTT solution for each SkinEthic tissue was measured. The optical density was measured at 540 nm. Data are presented in the form of percentage viability (MTT conversion relative to negative controls).
The test item was classified according to the following criteria:
(1)If the percentage relative mean tissue viability was >60% the test item was considered to be non-irritant (NI)
(2)If the percentage relative mean tissue viability was <60% the test item was considered to be irritant (I)
RESULTS : The relative mean viability of the test item treated tissues after 10-minute exposure period was 100.7%.
CONCLUSION: The test item was considered to be Non-Irritant.
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