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EC number: 234-858-4 | CAS number: 12037-47-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
Test material
- Reference substance name:
- Silicon orthophosphate
- EC Number:
- 234-858-4
- EC Name:
- Silicon orthophosphate
- Cas Number:
- 12037-47-7
- Molecular formula:
- O16P4Si3
- IUPAC Name:
- silicon(4+) tetraphosphate
- Details on test material:
- - Name of test material (as cited in study report): silicon orthophosphate
- Physical state: solid, light grey
- Analytical purity: >80% (w/w)
- Batch No.: 5
- Storage condition of test material: at room temperature, dry atmosphere, protected from light
Constituent 1
Test animals / tissue source
- Species:
- other: isolated bovine corneas
- Strain:
- not specified
Test system
- Vehicle:
- physiological saline
- Controls:
- other: number of eyes for the test item: 3
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 20%
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL test item preparation - Duration of treatment / exposure:
- 4 hours ± 5 minutes at 32 ± 1 °C
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- Fresh eyes from the slautherhouse were transported in HBSS containing Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation was initiated. The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS. Before the corneas were mounted in the corneal holders, they were carefully examined for defects and any defective eyes were discarded. The chambers were filled with RPMI containing 1% FBS and 2 mM L-glutamine and incubated for one hour at 32 ± 1°C in a water bath. After the equilibration period, the medium was removed from the chambers and replaced by fresh medium. An initial opacity measurement was performed on each of the corneas using the calibrated opacitometer. Afterwards the test item preparation or the control substance was introduced into the anterior chamber (closed-chamber method). After 4 hours ± 5 minutes incubation at 32 ± 1°C either the test substance or the control substance was removed and the epithelium was washed three times with medium. Once the medium was free of test substance, the cornea was fully rinsed with complete RPMI and opacity measurement was performed. Afterwards, the medium was removed from the chambers and filled with fresh medium. 1 mL of a 5 mg/mL sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 ± 1°C. Then the medium was removed and its optical density at 490 nm was determined, using a spectrophotometer. 3 corneas each were used for the test item, as negative control treated with physiological saline 0.9% NaCl or as positive control treated with imidazole 20% in physiological saline 0.9% NaCl.
The change in opacity for each cornea was calculated by subtracting the initial opacity reading from the final opacity reading. These values were corrected by subtracting from each the average change in opacity observed for the negative-control corneas. The mean opacity value for each treatment was calculated by averaging the corrected opacity values of each cornea for a given treatment.
The mean OD490 for the blank wells were calculated. The mean blank OD490 was subtracted from the OD490 of each well (corrected OD490). Any dilutions that were made to bring the OD490 values into the linear range of the spectrophotometer (OD490 should be less 1.500), were taken into account by multiplying the OD490 value of the dilution by the dilution factor. The final-corrected OD490 of the test article and the positive control were calculated by subtracting the average corrected OD490 of the negative control corneas from the corrected OD490 value of each treated cornea: final-corrected OD490 = (OD490 - mean blank OD490) - average-corrected negative control OD490. The mean OD490 value of each treatment group was calculated by averaging the final corrected OD 490 values of the treated corneas for that treatment condition. The following formula was used to determine the in vitro irritation score (IVIS): IVIS= mean opacity value + (15x mean OD490 value). Evaluation of the mean scores as follows: 0-3 = non irritant, 3.1-25 = mild irritant, 25.1 – 55 = moderate irritant, 55.1 – 80 = severe irritant, >80.1 = very severe irritant.
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:
- 93.33
- 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:
- -0.014
- 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:
- 93.13
- 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:
- 164.67
- 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:
- 1.966
- 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:
- 194.16
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Positive control
Any other information on results incl. tables
Table 1: Opacity data
Cornea No. |
Test item |
Initial Opacity |
Final Opacity |
Change of Opacity Value |
Corrected Oapcity Value |
1 |
Negative Control |
3 |
3 |
0 |
|
2 |
3 |
4 |
1 |
|
|
3 |
3 |
3 |
0 |
|
|
Mean Value |
3.00 |
3.33 |
0.33 |
|
|
4 |
Positive Control |
3 |
199 |
196 |
195.67 |
5 |
3 |
150 |
147 |
146.67 |
|
6 |
3 |
155 |
152 |
151.67 |
|
Mean Value |
3.00 |
168.00 |
165.00 |
164.67 |
|
7 |
Test Item |
2 |
102 |
100 |
99.67 |
8 |
2 |
102 |
100 |
99.67 |
|
9 |
2 |
83 |
81 |
80.67 |
|
Mean Value |
2.00 |
95.67 |
93.67 |
93.33 |
Table 2: Permeability data
Cornea No. |
Test Item |
OD490 |
Corrected OD490 Value |
1 |
Negative Control |
0.026 |
|
2 |
0.010 |
|
|
3 |
0.011 |
|
|
Mean Value |
0.016 |
|
|
4 |
Positive Control |
1.996 |
1.980 |
5 |
1.870 |
1.854 |
|
6 |
2.079 |
2.063 |
|
Mean Value |
1.981 |
1.966 |
|
7 |
Test Item |
0.003 |
-0.013 |
8 |
0.002 |
-0.014 |
|
9 |
0.001 |
-0.015 |
|
Mean Value |
0.002 |
-0.014 |
Table 3: In vitro irritation score
Cornea No. |
Test Item |
Corrected Opacity Value |
Corrected OD490 Value |
IVIS |
1 |
Negative Control |
0.00 |
0.026 |
|
2 |
1.0 |
0.010 |
|
|
3 |
0.00 |
0.011 |
|
|
Mean Value |
0.33 |
0.016 |
0.57 |
|
4 |
Positive Control |
195.67 |
1.980 |
|
5 |
146.67 |
1.854 |
|
|
6 |
151.67 |
2.063 |
|
|
Mean Value |
164.67 |
1.966 |
194.16 |
|
7 |
Test Item |
99.67 |
-0.013 |
|
8 |
99.67 |
-0.014 |
|
|
9 |
80.67 |
-0.015 |
|
|
Mean Value |
93.33 |
-0.014 |
93.13 |
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Cat. 1, H318
DSD: Xi, R41
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