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EC number: 241-782-5 | CAS number: 17814-85-6
- 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
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- Endpoint summary
- Stability
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- 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
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- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Feb 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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)
- Version / remarks:
- 9th October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (4-carboxybutyl)triphenylphosphonium bromide
- EC Number:
- 241-782-5
- EC Name:
- (4-carboxybutyl)triphenylphosphonium bromide
- Cas Number:
- 17814-85-6
- Molecular formula:
- C23H24BrO2P
- IUPAC Name:
- (4-carboxybutyl)triphenylphosphonium bromide
- Test material form:
- solid: crystalline
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: AB Schlachthof GmbH & Co. KG, 63739 Aschaffenburg, Germany
- Number of animals: not reported
- Characteristics of donor animals (e.g. age, sex, weight): 15 month
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Freshly isolated bovine eyes of donor cattle were collected from the abattoir. Excess tissue was removed from the excised eyes. The isolated eyes were stored in HBSS (Hank’s Balanced Salt Solution) containing 1% (v/v) penicillin/streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin) in the cooled slaughter-house and during transportation on the same morning to the laboratory using a Styrofoam box. The corneae were isolated on the same day after delivery of the eyes.
- Time interval prior to initiating testing: The corneae were directly used in the BCOP test on the same day.
- indication of any existing defects or lesions in ocular tissue samples: No
- Indication of any antibiotics used: see above
Test system
- Vehicle:
- other: 0.9% (w/v) NaCl in deionised water
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): 20% suspension (w/v) in 0.9% (w/v) NaCl - Duration of treatment / exposure:
- 240 min
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- COLLECTION OF BOVINE EYES
Freshly isolated bovine eyes of donor cattle were collected from the abattoir. Excess tissue was removed from the excised eyes. The isolated eyes were stored in HBSS (Hank’s Balanced Salt Solution) containing 1% (v/v) penicillin/streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin) in the cooled slaughter-house and during transportation on the same morning to the laboratory using a Styrofoam box. The corneae were isolated on the same day after delivery of the eyes.
PREPARATION OF CORNEAE
All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded. The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea. The corneae were directly used in the BCOP test on the same day.
Each isolated cornea was mounted in a specially designed cornea holder according to the description given in OECD guideline 437, which consists of anterior and posterior compartments, which interface with the epithelial and the endothelial sides of the cornea, respectively. The endothelial side of the cornea was positioned against the sealing ring (O-ring) of the posterior part of the holder. The cornea was gently flattened over the O-ring but stretching was avoided. The anterior part of the holder was positioned on top of the cornea and fixed in place with screws. Both compartments of the holder were filled with incubation medium. The posterior compartment was filled first to return the cornea to its natural convex position. Care was taken to assure that no air bubbles were present within the compartments.
For equilibration, the corneae in the holder were incubated in a vertical position for about one hour at 32 ± 1 °C in a water-bath. At the end of the incubation period, the medium was changed before basal opacity measurement (t0).
Only corneae with a value of the basal opacity < 7 were used. Sets of three corneae were used for treatment with the test item and for the negative and positive controls, respectively.
NUMBER OF REPLICATES
3
SOLVENT CONTROL USED
Saline (0.9% (w/v) NaCl in deionised water)
POSITIVE CONTROL USED
10% (w/v) Benzalkonium chloride (Sigma, lot BCBQ4331) in 0.9% (w/v) NaCl (saline) using sonication for 10 minutes.
APPLICATION DOSE AND EXPOSURE TIME
The anterior compartment received the test item suspension or the negative or positive controls at a volume of 0.75 mL each on the surface of the corneae via open chamber method, respectively. The corneae were incubated in a horizontal position at 32 ± 1 °C in the water-bath.
The incubation time lasted 240 minutes.
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period:
at least three times or more until phenol red was still discoloured (yellow or purple), or the test item was still visible
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
opacitometer (OP_KiT opacitometer (Electro Design, 63-Riom, France))
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
IVIS GHS / EU CLP
≤ 3 No Category
> 3; ≤ 55 No prediction can be made
> 55 Category 1
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of 3 replicates
- Value:
- 66.82
- Vehicle controls validity:
- valid
- Remarks:
- IVIS: 1.31
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- IVIS: 91.43
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for vehicle control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Results after 240 min treatment time
Test Group | Opacity value (t0) | Opacity value (t240) | Opacity value = Difference (t240-t0) of Opacity | Permeability at 490 nm (OD490) | IVIS | Mean IVIS | Standard Deviation in vitro score | Proposed in vitro Irritancy Score | ||
Mean | ||||||||||
Vehicle control | 0 | 1 | 1 | 0.33 | 0.07 | 0.065 | 2.05 | 1.31 | 0.64 | No Category |
0 | 0 | 0 | 0.061 | 0.82 | ||||||
0 | 0 | 0 | 0.065 | 0.98 | ||||||
Positive control | 2 | 80 | 77.67* | 0.551 | 0.486* | 84.95 | 91.43 | 5.88 | Category 1 | |
1 | 84 | 82.67* | 0.749 | 0.684* | 92.92 | |||||
2 | 88 | 85.67* | 0.782 | 0.717* | 96.42 | |||||
Test item | 0 | 68 | 67.67* | 0.075 | 0.010* | 67.81 | 66.82 | 4.54 | Category 1 | |
0 | 62 | 61.67* | 0.078 | 0.013* | 61.86 | |||||
0 | 71 | 70.67* | 0.073 | 0.008* | 70.78 |
*corrected values
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item caused an increase in corneal opacity. The calculated mean in vitro irritancy score was 66.82. According to OECD 437 fulfils the classification criteria for serious eye damage (EU CLP/GHS Category 1).
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