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EC number: 231-388-1 | CAS number: 7526-26-3
- 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:
- 2012-03-08 to 2012-05-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diphenyl methylphosphonate
- EC Number:
- 231-388-1
- EC Name:
- Diphenyl methylphosphonate
- Cas Number:
- 7526-26-3
- Molecular formula:
- C13H13O3P
- IUPAC Name:
- diphenyl methylphosphonate
- Details on test material:
- - Name of test material (as cited in study report): Diphenyl methylphosphonate
- Analytical purity: 99.88 %
- Stability under test conditions: not indicated by the sponsor
- Storage condition of test material: at room temperature, under nitrogen
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- freshly isolated bovine cornea
Test system
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): application of 0.75 mL test item dissolved in saline (20 % (w/v))
- Concentration (if solution): 20 % (w/v)
VEHICLE
- Amount(s) applied (volume or weight with unit): application of 0.75 mL test item dissolved in saline (20 % (w/v))
- Concentration (if solution):0.9 % (w/v)
- Lot/batch no. (if required): 310112 - Duration of treatment / exposure:
- 240 min (+/- 15 min). At the beginning of the test, the basal opacity of all corneae was recorded (t0). After 240 minutes of incubation with the test item, the opacity was measured again (t240).
- Number of animals or in vitro replicates:
- 3 freshly isolated bovine eyes were used per group (positive control, negative control, test item).
- Details on study design:
- Positive Control
10 % (w/v) Benzalkonium chloride (Sigma, 89555 Steinheim, Germany, lot no. 036K0208) in 0.9 % (w/v) NaCl in deionised water (saline, produced in-house, lot no. 310112) served as positive control.
Negative Control
Saline (produced in-house, lot no. 310112) served as negative control.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 6.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Evaluation of Results
Opacity
The change of opacity value of each treated cornea or positive and negative control corneae was calculated by subtracting the initial basal opacity from the post treatment opacity reading (t240 - t0), for each individual cornea. The average change in opacity of the negative control corneae was calculated and this value was subtracted from the change in opacity of each treated cornea or positive control to obtain a corrected opacity.
Permeability
The corrected OD490 value of each cornea treated with positive control and test item was calculated by subtracting the average negative control cornea value from the original permeability value for each cornea.
In Vitro Irritation Score Calculation
The following formula was used to determine the in vitro irritation score of the negative control:
In vitro Irritation Score = opacity value + (15 * OD490 value)
The following formula was used to determine the in vitro irritation score of the positive control and the test item:
In vitro Irritation Score = (opacity value - opacity value mean negative control) + (15 * corrected OD490 value)
The in vitro irritation score was calculated for each individual treatment and positive control cornea. The mean in vitro irritation score irritation value of each treated group was calculated from the individual in vitro irritation score values.
Depending on the score obtained, the test item was classified into the following category according to OECD guideline 437:
In vitro Irritation Score | In vitro Irritation Scale(according to OECD 437) |
≥ 55.1 | Corrosive/ Severe irritant CLP/EPA/GHS(Cat 1) |
Data Recording
The data generated were recorded in the raw data file. The results were presented in tabular form, including experimental groups with the test item, negative, and positive controls. The data of permeability measurement were registered and transferred into an Excel sheet.
Historical Data
Positive Control | Negative Control | |
Mean in vitro Irritation Score | 173.79 | 1.74 |
Standard Deviation | 43.90 | 0.74 |
Values of 138 studies with solid test items performed in 2008 to 2012 |
Results
Results after 240 Minutes Incubation Time | |||||||
Test Group | Opacity value = Difference (t240 -t0) of Opacity | Permeability at 490nm (OD490) | In vitro Score | Mean in vitro irritation score | Proposed in vitro Irritation Scale | ||
Mean | Mean | ||||||
Negative Control | 1 | 0,67 | 0,048 | 0.050 | 1.72 | 1.42 | Non corrosive / non severe irritant |
1 | 0,050 | 1.75 | |||||
0 | 0,053 | 0.80 | |||||
Positive Control | 230.33* | 0.035* | 230.85 | 234.77 | Corrosive / severe irritant | ||
257.33* | 0.020* | 257.63 | |||||
214.33* | 0.100* | 215.83 | |||||
Test Item | 6.33* | 0.046* | 7.02 | 6.50 | Non corrosive / non severe irritant | ||
3.33* | 0.054* | 4.14 | |||||
8.33* | 0.000* | 8.33 | |||||
*corrected values |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In conclusion, according to the current study and under the experimental conditions reported, the test item Diphenyl methylphosphonate is not corrosive / not severely irritating to the eye (CLP/EPA/GHS (Cat 1)).
- Executive summary:
In compliance with GLP criteria and according to OECD guideline 437 as well as EU guideline No 1152/2010: B.47, this in vitro study was performed to assess the corneal irritation and damage potential of Diphenyl methylphosphonate by means of the BCOP assay using fresh bovine corneae.
After a first opacity measurement of the fresh bovine corneae (t0), the 20 % (w/v) solution in saline (0.9 % (w/v) NaCl in deionised water) of the test item Diphenyl methylphosphonate, the positive, and the negative controls were applied to corneae and incubated for 240 minutes at 32 ± 1 °C. The posterior chamber contained MEM medium supplemented with sodium bicarbonate and L-glutamine and 1 % fetal calf serum (FCS) (complete medium = cMEM). After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240).
After the opacity measurements, permeability of the corneae was determined by measuring spectrophotometrically the transfer of fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.
With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed.
The positive control (10 % (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae corresponding to a classification as corrosive / severe irritant to the eye (CLP/EPA/GHS (Cat 1)).
Relative to the negative control, the test item Diphenyl methylphosphonate did not cause a relevant increase of the corneal opacity or permeability. The calculated mean in vitro irritation score was 6.50. According to OECD 437 the test item is classified as not corrosive / not severe irritant to the eye.
In conclusion, according to the current study and under the experimental conditions reported, the test item Diphenyl methylphosphonate is not corrosive / not severe irritant to the eye (CLP/EPA/GHS (Cat 1)).
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