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Diss Factsheets
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EC number: 947-766-0 | 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:
- From October 16, 2017 to October 19, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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)
- Deviations:
- no
- Principles of method if other than guideline:
- This study was performed in order to evaluate the potential of test substancein a Reconstructed human Cornea-like Epithelium (RhCE) model in an in vitro study. The EpiOcularTM Eye Irritation Test (EIT) predicts the acute ocular irritation potential of chemicals by measurement of irreversible tissue damage caused by cytotoxic effects in the human cornea model. Strategic combinations of other accepted test methods with OECD Guideline 492 can be used as replacement of the in vivo Draize test. It is utilized for the classification and labelling of chemicals concerning their eye irritation potential. The EpiOcularTM EIT is intended to differentiate substances that are “not eye irritant” from those that require labelling as either GHS category 1 or 2 for serious eye damage or eye irritation potential. Eye irritant substances are identified by their ability to produce a decrease in cell viability as determined. The cell viability is measured by dehydrogenase conversion of MTT (3-(4,5- Dimethylthiazol-2-yl)-2,5-iphenyltetrazoliumbromide), present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percentage reduction of cell viability in comparison with untreated negative controls is used to predict the eye irritation potential. The test was performed according to the protocol provided from MatTek Corporation.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Quaternary ammonium compounds, N,N,N'-tris(hydroxyethyl)-N,N'-dimethyl-N'-C16-18 (even numbered) and C18 unsatd., alkyltrimethylenedi-, bis(Me sulfates) (salts)
- EC Number:
- 947-766-0
- Molecular formula:
- Since the test substance is a complex UVCB, no defined molecular formula is available.
- IUPAC Name:
- Quaternary ammonium compounds, N,N,N'-tris(hydroxyethyl)-N,N'-dimethyl-N'-C16-18 (even numbered) and C18 unsatd., alkyltrimethylenedi-, bis(Me sulfates) (salts)
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: human-derived keratinocytes
- Details on test animals or tissues and environmental conditions:
- The EpiOcular 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.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 1) Tissue 51.7 mg
2) Tissue 49.8 mg - Duration of treatment / exposure:
- 6 h
- Duration of post- treatment incubation (in vitro):
- 18 h
- Number of animals or in vitro replicates:
- Duplicates
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % relative tissue viability
- Run / experiment:
- 6 h
- Value:
- 8.8
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
% Viability positive control and test substance:
Designation | Positive Control | Test substance |
% Viability (Tissue 1) | 39.90% | 7.30% |
% Viability (Tissue 2) | 43.00% | 10.30% |
% Viability Mean | 41.40% | 8.80% |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met (Inconclusive)
- Conclusions:
- Under the study conditions, based on the percentage viability of 8.8%, the test substance wasconsidered either eye irritant or inducing serious eye damage to the human eye.
- Executive summary:
An in vitro study was conducted to determine the eye irritation potential of the substance according to OECD Guideline 492, in compliance with GLP. Two tissues of the EpiOcular tissue model were treated with the test substance, positive control and negative control. Tissues were pre-wetted with 20 μL of PBS (Sterile Phosphate Buffered Saline) prior to topical application of approximately 50±2 mg of neat test substance. Sterile demineralised water was used as negative control and methyl acetate as positive control. After 6 h exposure on the surface of EpiOcular reconstructed ocular epithelium and 18 h post-incubation time, the viability of the tissues was assessed and compared to a negative control. The MTT viability test readings were performed at 570 nm without reference filter. Under the study conditions, based on the percentage viability of 8.8%, the test substance was concluded to be irritant to the human eye. However further GHS classification Category 1 or 2 cannot be concluded based on the result. Under the study conditions, based on the percentage viability of 8.8%, the test substance wasconsidered either eye irritant or inducing serious eye damage to the human eye (Andres, 2018).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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