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EC number: 826-676-4 | CAS number: 521065-36-1
- 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:
- 2018-12-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2017
- Deviations:
- yes
- Remarks:
- In the test item treated group, one cornea out of three was excluded from measurement as it was punctured. As other two measurements showed comparable results, this deviation had no influence on the study results.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lithium [ethanedioato-O,O’]tetrafluorophosphate
- EC Number:
- 826-676-4
- Cas Number:
- 521065-36-1
- Molecular formula:
- LiPF4C2O4
- IUPAC Name:
- Lithium [ethanedioato-O,O’]tetrafluorophosphate
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 180410
Purity: 99%
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Vitelco, -'s Hertogenbosch, The Netherlands
- Transport: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified - Duration of treatment / exposure:
- 240 ± 10 minutes
- Number of animals or in vitro replicates:
- 3 (1 was excluded from measurement)
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The isolated corneas were stored in a petri dish with cMEM (Earle’s Minimum Essential Medium (Life Technologies, Bleiswijk, The Netherlands) containing 1% (v/v) L-glutamine (Life Technologies) and 1% (v/v) Fetal Bovine Serum (Life Technologies)). The isolated corneas were mounted in a corneal holder (one cornea per holder) of BASF (Ludwigshafen, Germany) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 ± 1°C. The corneas were incubated for the minimum of 1 hour at 32 ± 1°C.
QUALITY CHECK OF THE ISOLATED CORNEAS
The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
NUMBER OF REPLICATES : 3 each for negative, positive control and test item
NEGATIVE CONTROL USED : physiological saline
POSITIVE CONTROL USED : 20% (w/v) Imidazole solution
APPLICATION DOSE AND EXPOSURE TIME
The medium from the anterior compartment was removed and 750 μL of the negative control and 20% (w/v) Imidazole solution (positive control) were introduced onto the epithelium of the cornea. The test item was weighed in a bottle and applied directly on the corneas in such a way that the cornea was completely covered. The holder was slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the solutions over the entire cornea. Corneas were incubated in a horizontal position for 240 ± 10 minutes at 32 ± 1°C.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the incubation the solutions and the test compound were removed and the epithelium was washed at least three times with MEM with phenol red (Earle’s Minimum Essential Medium Life Technologies).
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of a cornea was measured by the diminution of light passing through the cornea.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
- Others: Possible pHeffects of the test item on the corneas were recorded. Each cornea was inspected visually for dissimilar opacity patterns.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: The decision criteria as indicated in the TG was used.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 180
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
The corneas treated with the test item showed opacity values ranging from 168 to 191 and permeability values ranging from 0.020 to 0.076. The corneas were turbid after the 240 minutes of treatment with the test item. A pH effect of the test item was observed on the rinsing medium, the corneas were rinsed until no colour change of the medium was observed. Hence, the in vitro irritancy scores ranged from 169 to 192 after 240 minutes of treatment with test item.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.
- Acceptance criteria met for positive control: The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 124 and within two standard deviations of the current historical positive control mean.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In conclusion, since test item induced an IVIS > 55 (actual: 180), it is concluded that test item induces serious eye damage in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
- Executive summary:
The eye hazard potential of test item as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea was assessed using the Bovine Corneal Opacity and Permeability test (BCOP test) based on the most recent OECD guideline 437.
The eye damage of test item was tested through topical application to isolated bovine corneas for approximately 240 minutes.
The test item induced mainly serious opacity eye damage, resulting in a mean in vitro irritancy score of 180 after 4 hours of treatment. In conclusion, since test item induced an IVIS > 55, it is concluded that test item induces serious eye damage in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
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