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EC number: 229-552-2 | CAS number: 6606-65-1
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- OPHTHALMOLOGICAL TEST METHOD:
- Corneal tolerance: an intracorneal needle tract was made approx. in the middle of the stroma using a gauge 26 needle attached to a tuberculin syringe filled with the adhesive. A small amount of adhesive was deposited in the cornea as the needle was withdrawn.
- Subconjunctival tolerance: the adhesive was introduced subconctivally using a gauge 26 needle.
- Intraocular tolerance: the adhesive (0.1 cc) was injected into the anterior chamber through the limbus using a gauge 26 needle, carefully so as not to injure the iris, lens or corneal endothelium. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Enbucrilate
- EC Number:
- 229-552-2
- EC Name:
- Enbucrilate
- Cas Number:
- 6606-65-1
- Molecular formula:
- C8H11NO2
- IUPAC Name:
- butyl 2-cyanoprop-2-enoate
- Test material form:
- liquid
- Details on test material:
- - Histoacryl N (butyl 2-cyanoacrylate, CAS 6606-65-1),
- blue liquid,
- polymerization period 10 sec
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- 7 Albino rabbits weighing 1-2kg were used.
The animals were anesthetized with intravenous Nembutal Sodium and 0.5% proparacaine (Ophtetic) was applied topically.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- once
- Observation period (in vivo):
- 8 w
- Number of animals or in vitro replicates:
- 7
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Intracorneal tolernace
- Basis:
- mean
- Time point:
- other: week 4
- Score:
- 0
- Reversibility:
- other: no signs of inflammation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Subconjunctival tolerance
- Basis:
- mean
- Time point:
- other: week 4-8
- Score:
- 0
- Reversibility:
- other: subsiding reaction
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
RESULTS
Intracorneal tolerance:
Clinical: Of the four eyes, three had minimal edema noted during the first week. One had moderate corneal edema. Aqueous flares were noted in two eyes. One developed neovascularization. Chemosis was noted in one, which subsided without treatment. On the second week, corneal edema subsided. Aqueous flares disappeared. No further neovascularization was noted. From the fourth to the eighth week, no significant change was noted.
Histologic picture: Presence of chronic inflammatory cells was noted in the first week specimen. There was necrosis noted around the site of injection on the second week specimen. The fourth and eighth week specimen showed no inflammation. Stromal cells below the needle tract were noted to be minimal in all 4 specimens.
Subconjunctival tolerance:
Clinical: Minimal congestion of the conjunctiva was noted at the site of injection from the first to the eighth week.
Histologic picture: Intense reaction to the adhesive was noted in the first and second week specimens. This reaction subsided from the 4th to the 8th week. Granulomatous type of reaction was noted in this specimen.
Intracameral tolerance:
Clinical: Of the three eyes, one developed moderately severe corneal edema, while the other two developed minimal corneal edema. In the eye which developed moderately severe corneal edema, the anterior chamber was not visible and the cornea became staphylomatous. One had neovascularization. Aqueous flare was noted in one.
Histologic picture: The three specimens presented the same histologic picture: presence of acute and chronic inflammatory cells; breaks in the Descemet's membrane; increased vascularity and edema of the iris; presence of synechia-anterior and posterior.
Histopathologic results
Site | week 1 | week 2 | week 4 | week 8 |
intralamellar | - presence of chronic inflammatory cells- minimal stromal cells below needle tract | - necrosis around site of injection | - (-) inflammation | - mild vascularization- (-) inflammation |
subconjunctival | - presence of plasma cells and lymphocytes- fibroblastic proliferation- thickening of conjunctiva near limbus | - increased vascularity- acute inflammation | - chronic inflammation- milder | - foreign body giant cells- granulomatous reaction |
intracameral | - fibroblastic proliferation throughout cornea- acute and chronic inflammatory cells- break in Descemet's- posterior synechia- vascularization and edema of iris- inflammatory cells at angle | - presence of chronic inflammatory cells at angle- peripheral anterior synechia - detached Descemet's | - presence of chronic inflammatory cells- break in Descemet's- vascularization and edema of iris |
Applicant's summary and conclusion
- Interpretation of results:
- other: well tolerated
- Conclusions:
- Butyl 2-cyanoacrylate when applied in small amounts is well tolerated by the rabbit intralamellarly and subconjunctivally.
There was considerable reaction (toxic) when it was placed intracameral, even with the use of 0.1 cc of adhesive. - Executive summary:
SUMMARY
Results of experimental studies on butyl 2-cyanoacrylate showed that it is well tolerated by the rabbit intralamellarly and subconjunctivally, but produces toxic reaction when placed intracamerally even in small amounts (0.1 cc).
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