Registration Dossier
Registration Dossier
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EC number: 700-845-1 | CAS number: 133978-15-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Remarks:
- other: clinical investigations
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publications which meet basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 011
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 010
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- clinical investigations
- GLP compliance:
- no
Test material
- Reference substance name:
- [TN]2-Octyl cyanoacrylate[/TN][SPEC][/SPEC][AM][/AM]
- IUPAC Name:
- [TN]2-Octyl cyanoacrylate[/TN][SPEC][/SPEC][AM][/AM]
- Details on test material:
- commercial preparations of 2-octyl cyanoacrylate
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: not applicable
Test system
- Vehicle:
- other: commerical preparations
- Controls:
- other: not applicable
- Duration of treatment / exposure:
- various
- Observation period (in vivo):
- various
- Number of animals or in vitro replicates:
- not applicable
Results and discussion
In vivo
Results
- Irritation parameter:
- other: not applicable, no standard test
- Basis:
- other: not applicable, no standard test
- Time point:
- other: not applicable
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The publications describe clinical observations. No standard irritation scores have been read.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Several studies in literature describe the use of 2-octyl cyanoacrylate in ocular surgery in humans. A direct contact with the eyes is given in case studies where 2-octyl cyanoacrylate is applied to heal corneal perforations, but also skin contact in close proximity to the eyes is reported. Although the publications do not cover large clinical trials, the few case studies presented do give an indication on the behaviour of the tissue adhesive on the eyes.
The studies conclude that 2-octyl cyanoacrylate can well be used as wound barrier in ocular (and skin) surgery with a low side effect profile. Reversible eye irritation was reported occasionally, however, conjunctival injection, mild corneal edema, or anterior chamber cellular reaction were no more significant than those seen in other routine surgery cases. Based on the close structural similarity and same reaction mechanism, 1-methylheptyl cyanoacrylate is considered to be non-irritating to the eyes.
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