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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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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:
- 2 005
Materials and methods
- Endpoint addressed:
- eye irritation
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Retrospective case series
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Isobutyl cyanoacrylate
- IUPAC Name:
- Isobutyl cyanoacrylate
- Test material form:
- other: liquid
- Details on test material:
- - Isobutyl cyanoacrylate (Iso-Dent, Ellman Int. Inc., New York)
Constituent 1
Method
- Ethical approval:
- other: retrospective study, treatment at Duke University (1996-2002) performed after obtaining institutional review board exemption
- Details on study design:
- The charts of 20 patients (22 eyes) with corneal perforation <=3mm in size treated with isobutyl cyanoacrylate tissue adhesive were reviewed for etiology of perforation, visual outcome and complications.
- Exposure assessment:
- not specified
- Details on exposure:
- Of 70 patients with corneal perforations <=3mm, 22 eyes of 20 patients were treated with isobutyl cyanoacrylate at Duke University between 1996 and 2002. The adhesive was applied using a standard technique.
Results and discussion
- Results:
- Cyanoacrylate tissue adhesive is useful in the management of corneal perforation. Healing frequently occurs with the adhesive alone and no further surgical intervention is required. In this case series, isobutyl adhesive was highly effective at treating corneal perforations <=3mm in size. Additionally, the visual results in eyes treated with adhesive were excellent and, in this study, similar to those attained in eyes that underwent PK.
The experience of this study suggests that the use of cyanoacrylate tissue adhesive for corneal perforation can lead to healing, provide excellent visual results, and offer a useful alternative to surgery.
Any other information on results incl. tables
Nine (40.9%) of the 22 eyes healed with application of tissue adhesive. The mean interval of time needed for healing was 33.4 days (range 4 to 80 days; median 34 days). Seven eyes (31.8%) proceeded to PK with the adhesive in place. PK was performed not as a result of adhesive failure, but because of the belief that it offered improved visual potential. The mean time from adhesive application to PK was 33 days (range, 1 to 109 days; median 14 days). Four eyes had adhesive in place at the final follow-up visit (mean 187 days; range 75 to 270 days; median 201 days) and two patients were lost to follow-up. The most common complication was the need for reapplication in six eyes (27.3%) because of recurrent leaks or glue dislodgement. Of those eyes, three (50%) healed, two (33%) underwent PK, and one (17%) had glue in place at final follow-up. There was no case of endophthalmitis despite the fact that two patients had perforated bacterial keratitis.
Of the nine eyes that healed with tissue adhesive alone, best-corrected visual acuity (BCVA) improved in seven (77.8%) and remained stable in two (22.2%). In these eyes, mean BCVA at the time of perforation was 1.77 +/- 1.21 (logMAR scale) and at final follow-up (mean 100 days; median 240 days; range 39 to 1304 days) improved to 0.91 +/- 1.08 (P = 0.0078). Of the seven eyes that underwent PK, BCVA improved in five (71.4%), remained stable in one (14.3%), and decreased in one (14.3%). Mean BCVA at the time of perforation was 1.51 +/- 1.03 and at final follow-up (mean 739 days; median 365 days; range 120 to 2095 days) improved to 0.75 +/- 0.56 (P = 0.125). At final follow-up, there was no statistically significant difference in BCVA between eyes that healed with adhesive and those that underwent PK. Of the four eyes that had adhesive in place at final follow-up, BCVA improved in one (25%), remained stable in one (25%), and decreased in two (50%). ln these eyes, mean BCVA at perforation was 0.85 +/- 0.37 and at final follow-up (mean 187 days; median 201 days; range 75 to 270 days) 1.15 +/- 0.70 (P = 0.75).
Applicant's summary and conclusion
- Conclusions:
- Isobutyl cyanoacrylate tissue adhesive is highly effective at treating corneal perforations. Approximately half of the perforations <=3 mm healed and visual acuity improved in most of these eyes.
- Executive summary:
METHODS
The charts of 20 patients (22 eyes) with corneal perforation <=3 mm in size treated with isobutyl cyanoacrylate tissue adhesive were reviewed for etiology of perforation, visual outcome and complications.
RESULTS
Nine of the 22 eyes (40.9%) healed with application of adhesive alone. The mean interval of time needed for healing was 33.4 days. VisuaI acuity improved in seven eyes (77.8%) and remained stable in two (22.2%). Seven eyes (31.8%) proceeded to penetrating keratoplasty (PK) with the adhesive in place. Of these, visual acuity improved in five (71.4%), remained stable in one (14.3%), and decreased in one (14.3%). Six eyes (27.3%) required more than one application of adhesive.
CONCLUSIONS
Isobutyl cyanoacrylate tissue adhesive is highly effective at trealing corneal perforations. Approximately half of the perforations <=3 mm healed and visual acuity improved in most of these eyes.
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