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Diss Factsheets
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EC number: 700-217-7 | 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draft OECD Guideline: Draft Test Guideline for the Bovine Corneal Opacity and Permeability (BCOP) Test Method for Identifying Ocular Corrosives and Severe Irritants
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Purity: 100% as a reaction product
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Bovine Corneas
Bovine eyes were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were placed in Hanks' Balanced Salt Solution, containing Penicillin/Streptomycin (HBSS), and transported to the laboratory on ice packs. Immediately upon receipt of the eyes into the laboratory, preparation of the corneas was initiated.
Preparation of Corneas
The eyes were grossly examined for damage and those exhibiting defects were discarded. The tissue surrounding the eyeball was carefully pulled away and the cornea was excised such that a 2 to 3 mm rim of sclera was present around the cornea. The isolated corneas were then stored in a petri dish containing HBSS until they were mounted in a corneal holder. The corneas were mounted in the holders with the endothelial side against the O-ring of the posterior chamber. The anterior chamber was then positioned on top of the cornea and the screws were tightened. Starting with the posterior chamber, the two chambers were then filled with Minimum Essential Medium (EMEM) without phenol red, containing 1% fetal bovine serum and 2 mM L-glutamine (Complete MEM). The corneal holders were incubated at 32 ± 1 ºC for a minimum of 1 hour.
Test system
- Controls:
- yes
- Amount / concentration applied:
- Test Substance Preparation
The test substance was administered to the test system as a 20% (w/v) dilution in sterile, deionized water. The test substance dilution was prepared by weighing approximately 1,200 mg of the test substance into a prelabeled conical tube. Sterile, deionized water was added until a 20% (wlv) dilution was achieved and the conical was vortexed for approximately 1 minute prior to application. The resulting dilution was described as a cloudy yellow non-viscous suspension. For the remainder of this report, the test substance dilution is referred to as the test substance.
Test Substance pH Determination
0-14 pH and 0-6 pH paper were used to obtain a pH value. The test substance discolored the pH paper and the pH could not be determined.
Controls
Positive: Imidazole. 20% (w/v) solution in complete MEM without phenol red
Negative: sterile, deionized water - Duration of treatment / exposure:
- 4 hours
- Details on study design:
- The Bovine Corneal Opacity and Permeability Assay (BCOP) is used to assess the potential ocular irritancy of the test substance as measured by changes in opacity and permeability (to fluorescein) in isolated bovine corneas. Based on changes in corneal opacity and permeability (relative to the control corneas), an in vitro score is determined.
Opacity Measurement: The change in opacity for each cornea (including the negative control corneas) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting from each the average change in opacity observed for the negative control corneas. The mean opacity value of the treatment group was calculated by averaging the corrected opacity values of each cornea for that treatment condition.
Permeability Measurement: The mean OD490 value for the blank wells was calculated. The mean blank OD490 value was then subtracted from the raw OD490 values of each well (corrected OD490). Any dilutions that were made to bring the OD490 readings into the linear range of the plate reader (OD490 should be less than 1,500), had each diluted OD490 reading multiplied by the dilution factor. The final corrected OD490 values of the test substance and the positive control were then calculated by subtracting the average corrected OD490 value of the negative control corneas from the corrected OD490 value of each treated cornea:
Final Corrected OD490 = (raw OD490 - mean blank OD490) - average corrected negative control OD490
The mean OD490 value of the treatment group was calculated by averaging the final corrected OD490 values of the treated corneas for that treatment condition.
The following formula was used to determine the in vitro score:
In Vitro Score = Mean Opacity Value + (15 x Mean OD490 Value)
The following classification system was established by Sina et al (Fundamental and Applied Toxicology 26:20-31) based on studies with a wide range of test materials. While this classification system provides a good initial guide to interpretation of these in vitro data, these specific ranges may not be applicable to all classes of materials.
In Vitro Score:
0 to 25 = mild irritant
25.1 to 55 = moderate irritant
55.1 and above = severe irritant
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- Mean Opacity Value + (15 x Mean OD490 Value)
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Imidazole had a mean opacity of 63.7 and a mean OD490 of 1.726. Giving an in vitro score of 89. Since the results of the positive control fell within two standard deviations of the historical mean (within a range of 68.3 to 131.4), the assay was considered valid.
The test substance had a mean opacity of 0.0 and a mean OD490 (Permeability) of 0.003. Giving an in vitro score of 0.0. Based on the classification, the test substance would be considered a mild irritant.
Criteria for Determination of a Valid Test
The BCOP assay was accepted when the positive control (Imidazole) caused an in vitro score that fell within two standard deviations of the historical mean, updated every three months.
Any other information on results incl. tables
Opacity Results
Treatment | Initial | Final | Change | Corrected | Avg | Std Dev |
Test Substance | 2 | 5 | 3 | 1.0 | 0.0 | 1.0 |
2 | 3 | 1 | -1.0 | |||
1 | 3 | 2 | 0.0 | |||
2 | 5 | 3 | 1.0 | |||
3 | 4 | 1 | -1.0 | |||
Negative Control (sterile, Dl water) | 4 | 7 | 3 | NA | 2.0 | |
3 | 5 | 2 | NA | |||
2 | 3 | 1 | NA | |||
Positive Control (Imidazole) | 1 | 64 | 63 | 61.0 | 63.7 | 8.3 |
1 | 60 | 59 | 57.0 | |||
2 | 77 | 75 | 73.0 |
x
Permeability Results
Treatment | Initial OD490 | Dilution Factor | Corrected OD490 | Avg | Std Dev |
Test Substance | 0.003 | 1 | 0.000 | 0.003 | 0.002 |
0.007 | 1 | 0.004 | |||
0.005 | 1 | 0.002 | |||
0.004 | 1 | 0.001 | |||
0.007 | 1 | 0.004 | |||
Negative Control (sterile, Dl water) | 0.007 | NA | 0.007 | 0.003 | |
-0.004 | NA | -0.004 | |||
0.005 | NA | 0.005 | |||
Positive Control (Imidazole) | 0.342 | 5 | 1.707 | 1.726 | 0.119 |
0.324 | 5 | 1.617 | |||
0.371 | 5 | 1.852 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mild irritant
- Executive summary:
The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test substance to isolated bovine corneas. Bovine corneas, obtained as a by-product from freshly slaughtered animals, were mounted in special holders and exposed to the test substance. An in vitro score was determined for the test substance based on the induction of opacity and permeability (to fluorescein) in the isolated bovine corneas. Based on the classification scheme, the test substance would be considered a mild irritant.
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.
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