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EC number: - | 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
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
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- Endpoint summary
- Stability
- Biodegradation
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- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Jan - 03 Feb 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- yes
- Remarks:
- Due to small amount of the test item no retention sample is stored at the test facility.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - name of test material (as cited in study report): Reaction mass of tetra (potassium and sodium) (2R,3R)-2-hydroxy-3-(phosphonatooxy)succinate and tetra (potassium and sodium) (2S,3S)-2-hydroxy-3-(phosphonatooxy)succinate
- physical state: White to slightly yellowish powder of crystalline appearance
Constituent 1
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- other: bovine eyes
- Details on test animals or tissues and environmental conditions:
- Identification of the source of the eyes, storage and transport conditions:
- Source: Hubert Bahlmann GmbH & Co. Versandschlachterei Spezialmischfutterwerk KG, Lindern, Germany
- Donor animals: age: 6 to 12 months
- Transport medium and temperature conditions: Hanks´ Balanced Salt Solution (HBSS) containing penicillin (100 IU/mL) and streptomycin (100 μg/mL)
Preparation of the eyes (before exposure)
- Eyes free of defects (scratches, neovascularisation): yes
- Dissection of the eyes and treatment: Corneas were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders with anterior (epithelium) and posterior (endothelium) chambers.
- Test medium and temperature conditions used in the cornea holder:
Eagle´s Minimum Essential Medium (EMEM) with and without phenol red; prior to use: pre-warmed to 32 ± 1 °C
- Equilibration time: 1 h at 32 ± 1 °C
- Quality check of the equilibrated corneas: free of macroscopic defects, initial opacity of 3 (Note: Corneas with an initial opacity above 7 in the opacitometer or with any macroscopic defects were discarded.)
Determination of the initial opacity:
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Specification of the device: BASF 2011-13; 67063 Ludwigshafen am Rhein, Germany
- 1 mL sodium fluorescein solution (5 mg/mL in 0.9% sodium chloride solution)
- microplate reader: Tecan Sunrise Magellan Version 6.4, Tecan Deutschland GmbH, 74564 Crailsheim, Germany
Test system
- Vehicle:
- physiological saline
- Controls:
- other: number of eyes for the negative control: 3; number of eyes for the positive control: 3
- Amount / concentration applied:
- 20% solution in 0.9% sodium chloride solution (w/v)
- Duration of treatment / exposure:
- 4 h at 32 ± 1 °C
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- number of eyes for the test item: 3
- Details on study design:
- Test conditions:
- Short description of the method used: closed-chamber method
The controls or test substance were added to completely cover the corneas's epithelium in the anterior chamber. Corneas were exposed for 4 h with the test substance or the controls.
Post-exposure treatment:
- Removal of the test substance: The test substance was removed from the anterior chamber and the epithelium washed at least three times.
- Medium for washing the corneas: EMEM containing phenol red
- Medium for final rinsing: EMEM without phenol red
Determination of the final opacity:
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Time of determination: Directly after refilling fresh EMEM without phenol red in the anterior chamber the final opacity was measured.
- Specification of the device: BASF 2011-13; 67063 Ludwigshafen am Rhein, Germany
Determination of the corneal permeability:
- Method: Sodium fluorescein solution was added to the anterior chamber of the cornea holder while the posterior chamber was filled with fresh medium. The amount of sodium fluorescein that crosses into the posterior chamber was quantitatively measured via UV/VIS spectrophotometry at 490 nm recorded as optical density (OD490).
- Amount and concentration of the dye: 1 mL sodium fluorescein solution (5 mg/mL; dissolved in 0.9% sodium chloride solution)
- Incubation time: 90 ± 5 min at 32 ± 1 °C
- Treatment for measuring: OD490 in a microplate.
- Specification of the spectrophotometer: Tecan Sunrise, Tecan Deutschland GmbH, 74564 Crailsheim, Germany
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: opacity
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- < 0.01
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: permeability
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- < 0.01
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: IVIS
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- < 0.01
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: opacity
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- ca. 73.413
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control
- Irritation parameter:
- other: permeability
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- ca. 0.808
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control
- Irritation parameter:
- other: IVIS
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- ca. 85.528
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control
- Irritant / corrosive response data:
- The acceptance criteria for the solvent control are met.
The calculated IVIS value for the positive control was within two standard deviations of the current historical mean and well above the cut-off value of 55. Thus, the acceptance criteria for the test were fulfilled.
The calculated IVIS value for the test substance is below the cut-off value of 3 (UN GHS no category). Thus, the test substance is not classified for eye irritation or serious eye damage using the BCOP test method. - Other effects:
- not applicable
Any other information on results incl. tables
Table 1: Opacity Values
|
Cornea No. |
Opacity [Opacity Units] |
Corrected Opacity |
||
|
Mean of group |
Standard deviation |
|||
0.9% NaCl |
1 |
1.594 |
1.408 |
1.408 |
0.227 |
2 |
1.155 |
||||
3 |
1.474 |
||||
20% Imidazol |
4 |
70.877 |
69.469 |
73.413 |
6.455 |
5 |
71.315 |
69.907 |
|||
6 |
82.270 |
80.862 |
|||
PWS (20% w/v) |
7 |
0.677 |
-0.731 |
-1.634 |
1.330 |
Table 2: In vitro irritancy score (IVIS)
|
Cornea No. |
Opacity |
Permeability |
IVIS |
||
Per Cornea |
Per Group |
|||||
Mean |
SD |
|||||
0.9% NaCl |
1 |
1.594 |
0.020 |
1.894 |
1.733 |
0.333 |
2 |
1.155 |
0.013 |
1.350 |
|||
3 |
1.474 |
0.032 |
1.954 |
|||
20% Imidazol |
4 |
69.469 |
0.814 |
81.679 |
85.528 |
6.265 |
5 |
69.907 |
0.816 |
82.147 |
|||
6 |
80.862 |
0.793 |
92.757 |
|||
PWS (20% w/v) |
7 |
-0.731 |
-0.005 |
-0.806 |
-1.664 |
1.351 |
8 |
-1.010 |
0.003 |
-0.965 |
|||
9 |
-3.161 |
-0.004 |
-3.221 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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