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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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
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:
- other: Study was performed according to the recommended guidelines and GLP, and without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: The OTWG on the ICCVAM and the NICEATM, BRD: current status of in vitro test methods for identifying ocular corrosives and severe irritants: The BCOP Test Method, March 2006.
- Qualifier:
- according to guideline
- Guideline:
- other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 124. Bovine Opacity and Permeability assay - SOP of Microbiological Associates Ltd., 1999.
- Qualifier:
- according to guideline
- Guideline:
- other: Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992.
- Principles of method if other than guideline:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing. As a consequence a validated and accepted in vitro test for eye irritation should be performed before in vivo tests are conducted. One of the proposed in vitro eye irritation tests is the Bovine Corneal Opacity and Permeability (BCOP) test. The BCOP assay measures two important components which are predictive of irritation, corneal opacity and permeability. Although the BCOP test method is not yet validated, the EU national regulatory authorities accept positive outcomes (severe eye irritants) of this method for classification and labelling (R41). Where no positive result is obtained, an in vivo test is subsequently required.
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals / tissue source
- Species:
- other: isolated corneas from bovine eyes
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 750 µl undiluted substance
- Duration of treatment / exposure:
- Corneas were incubated in a horizontal position for 10 +/- 1 minutes at 32 +/- 1°C
- Observation period (in vivo):
- After the incubation the control or test substance was removed and the epithelium was washed at least three times with cMEM. The medium in the posterior compartment was removed and both compartments were refilled with fresh cMEM. Subsequently the corneas were incubated for 120 +/-10 minutes at 32 +/- 1°C. After the completion of the incubation period opacity determination was performed.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: in vitro irritancy scores: opacity and permeability
- Basis:
- mean
- Time point:
- other: 10 minutes
- Score:
- 0
- Max. score:
- 0.2
- Reversibility:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean in vitro irritancy score (uncorrected) obtained with the negative control was less than 3.1 indicating that the negative controls did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% w/v Benzalkonium Chloride) was within the historical positive control data range (Appendix I, table 5). It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
The in vitro irritancy scores of the corneas treated with the test substance ranged from -0.1 to 0.2 with a mean of 0.0. Since all in vitro irritancy scores were less than 3.1, the test substance was considered non irritant.
Finally, it is concluded that this test is valid and that the test substance is non irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
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