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EC number: 915-179-9 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from September 18th to September 18th, 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well described GLP study performed on the KH2PO3 monoconstituent substance. This form exists at lower pH (< 5.5) with a higher potential for irritation property
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
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)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: OECD series on testing and assessment n. 113- Supplement to test Guidelines n. 437 and 438
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium Hydrogen Phosphonate KH2PO3
- IUPAC Name:
- Potassium Hydrogen Phosphonate KH2PO3
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Molecular formula: KH2PO3
- Substance type: inorganic
- Physical state: white hygroscopic powder
- Storage condition of test material: ambient condition
Before the main assay, a solubility test was carried out resuspending the test item at 20% w/v (200 mg/mL) using physiological saline. Dissolution in the vehicle was immediate.
In the main assay the test item was dissolved in the same vehicle at the same concentration.
Constituent 1
Test animals / tissue source
- Species:
- other: in vitro; bovine cornea
- Details on test animals or tissues and environmental conditions:
- Eyes were supplied by a butcher service.
- Source: Butcher Service s.r.l- Mattatoio n. 2067M, Viterbo, IT
- Age of animals: 6-12 months;
- Killing time: from 10:45 to 12:30 in the morning;
- Transport condition: at c.a 4°C in eye transport solution;
Test system
- Amount / concentration applied:
- MEDIA AND REAGENTS
Eyes transport solution: hanks balanced salt solution (HBSS);
Complete EMEM (with and without phenol red);
Sodium fluorescein solution - Duration of treatment / exposure:
- Opacity determination: exposition of the corneas in horizontal position for 4 hours ± 5 minutes, incubated in a liquid bath at 32 ± 1 °C.
No post-exposure period.
Permeability: the corneas were horizontally incubated for approximately 90 minutes in a liquid batch at 32 ± 1 °C. - Observation period (in vivo):
- Visual observation of corneas through chamber glasses and opacity determination.
Permeability determination after incubation - Details on study design:
- PREPARATION OF CORNEAS
1) Eyes were examined for the presence of any defects (opacity, scratches or pitting of the corneal surface, vascularisation or pigmentation);
2) Cornea excision: each cornea with 2-3 mm of surrounding sclera was dissected from the eye using a scalpel, scissors and forceps and placed into a Petri dish containing HBSS (Hanks balanced salt solution);
3) Mounting of the cornea in the chamber with the endothelial surface placed in contact with the O-ring of the posterior part of the chamber in the correct position; the chamber was then filled with complete EMEM without phenol red maintained at 32 ± 1°C (posterior part of the chamber first to maintain convexity).
4) Equilibration: the corneas in their holders were incubated in a liquid bath at 32 ± 1°C at least for 1 hour to permit metabolic stabilisation.
At the end of the pre-dose incubation period, the two chambers were drained (anterior first) and re-filled with complete EMEM without phenol red maintained at approximately 32°C (posterior first).
5) Selection: basal opacity of corneas was determined by means of a calibrated meter, measuring difference in light transmission between the corneas placed into the beam paths versus air (opacitometer).
Cornea s with a basal value >= 7 arbitrary units were excluded from testing.
6) Determination of the mean opacity of the cornea;
METHOD
Test item: open chamber for a viscous substance;
Positive and negative controls: closed chamber method for free-flowing solutions.
The medium was completely removed from the anterior chamber. Corneas were treated with 0.75 mL of treatment volumes. After that, in the chambers the treatment was removed and corneas were exposed in horizontal position for 4h hours ± 5 minutes, incubated in a liquid bath at 32 ± 1°C. After a first washing with complete EMEM with phenol red a final wash with pre-warmed complete EMEM without phenol red was carried out. Finally, the anterior chamber was re-filled with pre-warmed complete EMEM without phenol red. Corneas were maintained in horizontal position, for further 2 hours ± 10 minutes, incubated in a liquid bath at 32 ± 1°C.
OBSERVATIONS
Visual observation through chamber glasses and pertinent observation recorded (e.g. tissue peeling/exfoliation, residual test substance, non-uniform opacity pattern etc.);
Opacity determination of all corneas: basal opacity of corneas was determined by means of a calibrated meter, measuring difference in light transmission between the corneas placed into the beam paths versus air (Opacitometer);
Permeability by treatment with fluorescein: 1 mL aliquot of 5 mg/mL sodium fluorescein solution in DPBS. The corneas were horizontally incubated for approximately 90 minutes in a liquid batch at 32 ± 1 °C. The quality ccontrols of the fluorescein solutions were assayed.
Permeability determination: measurement of the optical density of each sample using a spectrophotometer set at 490 nm.
Tissue retention.
At the end of the procedure, corneas were retained and fixed in 10% neutral buffered formalin.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: in vitro irritancy score (IVIS)
- Basis:
- other: mean IVIS = mean opacity score + (15 x mean permeability OD 490 score)
- Time point:
- other: IVIS test item: 1.1; IVIS positive control: 89.5
- Irritant / corrosive response data:
- PREPARATION OF THE CORNEAS
A total of 14 corneas were processed (out of 16 delivered) for a final selection of the 9 required corneas according to basal opacity.
Eight corneas were actually assigned to treatment since the number of corneas was sufficient to cover all treatments scheduled in the experiment.
OBSERVATIONS
Negative control samples: no corrosion as the mean opacity values were homogeneous and in line with the expected values for this kind of control.
The positive control induced opacity of the whole cornea surface with a mean increase of the opacity value equal to 181.0. Severe opacity was noted in the two replicates at the macroscopic examination performed at the end of the 4-hour incubation period.
The test item increased very slightly the corneal opacity, being the calculated mean value 1.0. At the macroscopic observation the three corneas did not show any abnormality.On the other hand, cornea permeability was essentially unaffected when compared to that of negative control. The calculated mean permeability OD490 value was 0.0049.
The corneal permeability was also increased. The calculated mean permeability OD490 value was 2.8002. - Other effects:
- Classification of the test item was performed according to the in vitro irritancy score:
> 55 corrosive or severely irritant;
In addition, the test item was evaluated also for the eye irritancy potential according to the criteria stated in the OECD Supplement to Test Guidelines nos. 437 and 438.
0-3 Non eye irritation
3.1 - 25 Mild eye irritant
25.1 - 55 Moderate eye irritant
Any other information on results incl. tables
Table. 1
Treatment Code | Pre-test cornea number | Basal opacity | Mean group basal opacity | |
N1 | 13 | 0 | 0.3 | |
N2 | 14 | 1 | ||
N3 | 3 | 0 | ||
P1 | 2 | 4 | 2.0 | |
P2 | 1 | 0 | ||
A1 | 4 | 1 | 0.3 | |
A2 | 5 | 0 | ||
A3 | 6 | 0 | ||
Mean: 0.64 ° | ||||
° the mean refers to the total number of selected pre-test corneas | ||||
^ showing a small lesion on the surface |
TABLE 2 - Observation |
|||||||||||||||
Treatment | OPACITY | MACROSCOPIC OBSERVATIONS of the CORNEA | PERMEABILITY | ||||||||||||
Basal Opacity Value | Assay Opacity Value | Value corrected (basal value) | Value Corrected (negative control) | OD490 | Dilution factor | Value Corrected (dilution factor) | Value Corrected (negative control) | ||||||||
N1 | 0 | 3 | 3 | N/A | No macroscopic changes | 0,037 | 1 | 0,037 | N/A | ||||||
N2 | 1 | -1 | 0 | * | N/A | No macroscopic changes | 0,014 | 1 | 0,014 | N/A | |||||
N3 | 0 | -1 | 0 | * | N/A | No macroscopic changes | 0,031 | 1 | 0,031 | N/A | |||||
Mean | 1 | Mean | 0,0225 | ||||||||||||
SD | 1,7 | SD | 0,012 | ||||||||||||
CV % | 170 | CV % | 53,33 | ||||||||||||
P1 | 4 | 185 | 181 | 180 | Strongly opaque | 1,85 | 1 | 1,85 | 1,828 | ||||||
P2 | 0 | 183 | 183 | 182 | Strongly opaque | 0,761 | 5 | 3,805 | 3,783 | ||||||
Mean | 181 | Mean | 2,805 | ||||||||||||
SD | 1,4 | SD | 1,3824 | ||||||||||||
CV % | 0,8 | CV % | 49,28 | ||||||||||||
C1 | 1 | 1 | 0 | 0 | * | No macroscopic changes | 0,008 | 1 | 0,008* | 0 | |||||
C2 | 0 | 4 | 4 | 3 | No macroscopic changes | 0,042 | 1 | 0,042 | 0,02 | ||||||
C3 | 0 | 1 | 1 | 0 | No macroscopic changes | 0,014 | 1 | 0,014* | 0 | ||||||
Mean | 1 | Mean | 0,0065 | ||||||||||||
SD | 1,7 | SD | 0,0113 | ||||||||||||
CV % | 170 | CV % | 173,85 | ||||||||||||
* : Negative values assumed to be 0 for calculation purpose | |||||||||||||||
N1-3: Negative control | P1-2: Positive control | C1-3: Test item | |||||||||||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria of the OECD Guideline 437: not corrosive/sever irritant to the eye. Criteria OECD supplement to Test Guidelines 437 and 438: no irritant effect to the eye Criteria used for interpretation of results: EU
- Conclusions:
- Very slight alterations of cornea opacity but not of permeability were recorded after treatment with the test item. According to the OECD Guideline no. 437, the test item is not to be classified as corrosive or severely irritant to the eye.
Moreover, according to the criteria stated in the OECD Supplement to Test Guidelines nos. 437 and 438, there is no indication of an irritant effect to the eye
Very slight alteration of cornea opacity but not of permeability were recorded after treatment with the test item.. The IVIS score for the test item was 1.1.
According with OECD Guideline no. 437 the test item is not to be classified as corrosive or severe irritant to the eye. Moveover, according with OECD Supplement to Test Guidelines nos. 437 and 438 there is no indication of an irritant effect to the eye. - Executive summary:
The potential of the test item, Potassium hydrogen phosphonate, formula KH2PO3, to cause corrosion/severe irritation by using the Bovine Corneal Opacity and Permeability (BCOP) assay, was examined in agreement with OECD Guideline no. 437 (adopted on) and OECD Supplement to Test Guidelines nos. 437 and 438.
The test item was tested dissolved/suspended at 20% (w/v) in physiological saline (being a solid non surfactant) on the epithelial surface of three idoneous bovine corneas, for an exposure period of 4 hours.Positive and negative controls [at 20% (w/v) Imidazole solution in physiological saline and physiological saline alone, respectively] were concurrently tested in similar condition.
The mean opacity detected with an opacitometer at the end of the test item exposure period was 1.0, slightly higher than the negative control. After the determination of opacity, the epithelial surface was treated with a 0.5% solution of sodium fluorescein in DPBS for 90 minutes, to investigate alteration in cornea permeability.
Mean OD490value of the corneas treated with the test item was essentially unaffected by treatment, as well as the negative control.
Negative and positive controls gave the expected results.
The results obtained indicate that the test item induces slight changes in cornea opacity but not in corneal permeability under the reported experimental conditions. The calculated in vitro irritancy score (IVIS) for the test item is 1.1.
According to the OECD Guideline no. 437, the test item is not to be classified as corrosive or severely irritant to the eye. Moreover, according to the criteria stated in the OECD Supplement to Test Guidelines nos. 437 and 438, there is no indication of an irritant effect to the eye.
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