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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437 of July 2013: Bovine Corneal Opacity and Permeability test method for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
Test animals / tissue source
- Species:
- other: in vitro test
- Strain:
- other: bovine eyes
Test system
- Vehicle:
- physiological saline
- Amount / concentration applied:
- 750 µl of test substance, 20% in physiol. saline, positive control solution (20% w/w imidazole in physiol. saline) or negative control solution (physiol. saline) was introduced into the anterior part of each cornea holder. Following application, turning of the holder into horizontal position and its slight rotation ensured uniform distribution of the test substance over the surface of the cornea.
- Duration of treatment / exposure:
- 4 hours (± 5 min.).
Each cornea holder was incubated in a horizontal position at 32°C ± 1°C in a waterbath. Following incubation, the test substance, positive and negative controls were removed and the epithelial surface of the cornea washed, at least three times or until the wash medium (EMEM* with phenol red) was clear and there was no discolouration.
* EMEM, Eagles Minimal Essential Medium - Details on study design:
- Each treatment group (test substance, negative/positive controls) comprised 3 corneas from bovine eyes. Each cornea surrounded by ca. 2 to 3 mm of sclera was mounted to a holder. Eyes were maintained and transported to the laboratory and isolated corneas stored in sufficient HBSS* containing 1% penicilin/streptomycin solution until being used. The eyes were used within 4 hours of slaughter. Adequate exposure of the epithelial surface of the cornea to the test substance was provided. Opacity of the cornea was determined by measurement of light transmission through the centre of each mounted cornea using a calibrated opacitometer. Permeability of the cornea was determined by spectophotometric measurement at 490 nm (OD490) of medium from the posterior compartment of the cornea holder after addition of 1 ml of sodium fluorescein solution (4 mg/ml) to the anterior compartment, thus determining the degree of penetration of sodium fluorescein through all corneal cell layers. Prior to the spectophotometric measurement, incubation with fluorescein solution had happened in horizontal position of the cornea holder at 32°C ± 1°C for 90 ± 5 minutes in a waterbath. Then the medium in the posterior compartment was mixed by drawing approximately 2.5 ml gently up and down a 5 ml syringe, with a needle attached, three times. Any solution giving an OD490 value above 1.8 was diluted 1 in 5 with cMEM.
Effects to the cornea (corresponding to possible eye damage) were measured as opacity and permeability, which when combined gave an In Vitro Irritancy Score (IVIS) for each treatment group. A substance that induces an IVIS greater than 55 is defined as a corrosive or severe irritant.
*HBSS Hanks Balanced Salt Solution containing Ca++ and Mg++ without phenol red
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- replicate 1
- Value:
- 0.333
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- replicate 2
- Value:
- 1.333
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- replicate 3
- Value:
- 1.333
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- replicate 1
- Value:
- 0.483
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- replicate 2
- Value:
- 1.063
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- replicate 3
- Value:
- 1.078
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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