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EC number: 212-774-9 | CAS number: 868-19-9
- 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:
- November 3, 2014 - November 4, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- (2013)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- (2010)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: The Ocular Toxicity Working Group (OTWG) of ICCVAM and NICEATM, Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The BCOP Test Method, March 2006
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Strontium tartrate
- EC Number:
- 212-774-9
- EC Name:
- Strontium tartrate
- Cas Number:
- 868-19-9
- Molecular formula:
- C4H4O6Sr
- IUPAC Name:
- strontium(2+) 2,3-dihydroxybutanedioate
- Details on test material:
- - Name of test material (as cited in study report): Strontium tartrate (anhydrous)
- Appearance: Off-white powder
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Since no workable suspension in physiological saline could be obtained, the test substance was added on top of the corneas, in such a way that the cornea was completely covered
- Amount applied: 317 to 360 mg per cornea
NEGATIVE CONTROL
- Amount applied: 750 µL of physiological saline per cornea
POSITIVE CONTROL
- Amount applied: 750 µL of a 20% (w/v) Imidazole solution in physiological saline per cornea - Duration of treatment / exposure:
- 4 hours
- Details on study design:
- TEST SITE
- Isolated bovine cornea
- Three corneas were used for each treatment group
- The corneas were incubated at 32 ± 1°C
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with MEM+phenol red
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- After exposure, the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement
- Following the final opacity measurement, permeability of the cornea to Na-fluorescein (Merck) was evaluated (90 minutes incubation)
- After the incubation period, permeability evaluation of the cornea was performed
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate the mean in vitro score:
Mean in vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
- Opacity and permeability values were also evaluated individually
TOOL USED TO ASSESS SCORE:
- Opacitymeter and microplate reader
DATA EVALUATION:
- A test substance that induces a mean IVIS >55 is classified with Eye Irr. Cat. 1 in accordance with the CLP Regulation
- A test substance that induces a mean IVIS ≤ 3 is not classified for Eye irritation in accordance with the CLP Regulation
- For a test substance that induces a mean IVIS of >3 - ≤55, it cannot be concluded whether the substance needs to be classified or not and for these substances, more (in vivo) information is needed
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In vitro irritancy score (IVIS)
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 1.9
- Remarks on result:
- other: Negative control: 0; Positive control: 123.9
Any other information on results incl. tables
Summary of opacity, permeability and in vitro scores:
Treatment |
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score |
Negative control |
0.0 |
0.000 |
0.0 |
Positive control |
90.3 |
2.237 |
123.9 |
Strontium tartrate (anhydrous) |
0.3 |
0.105 |
1.9 |
Individual in vitro irritancy scores:
Eye |
In vitro Irritancy Score |
Negative control |
|
1 |
0.0 |
2 |
-0.1 |
3 |
0.1 |
Positive control |
|
13 (*) |
131.3 |
5 |
108.8 |
6 |
131.5 |
Strontium tartrate (anhydrous) |
|
10 |
1.8 |
11 |
0.9 |
12 |
3.1 |
(*) Cornea 4 was replaced by cornea 13, since cornea 4 was damaged and discarded. Cornea 7, 8 and 9 were used for another test substance.
No pH effect of the test substance was observed on the rinsing medium.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of a Bovine Corneal Opacity and Permeability test in which Strontium tartrate (anhydrous) did not induce ocular irritation (mean in vitro irritancy score of 1.9), Strontium tartrate (anhydrous) has no eye irritating properties and does not need to be classified for Eye irritation in accordance with the CLP Regulation.
- Executive summary:
Using the Bovine Corneal Opacity and Permeability test (BCOP test) Strontium tartrate (anhydrous) was screened for its eye irritancy potential in accordance with OECD 437 and according to GLP principles. The substance was applied as such directly on top of the corneas in such a way that the cornea was completely covered (317 to 360 mg per cornea). Adequate negative and positive controls were included. The substance did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.9 after 240 minutes of treatment. Since the substance induced a mean IVIS ≤ 3, the substance does not need to be classified for Eye irritation in accordance with the CLP Regulation.
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