Registration Dossier

Diss Factsheets

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:
2005
Reference Type:
publication
Title:
Unnamed
Year:
2011
Reference Type:
publication
Title:
Unnamed
Year:
2001
Reference Type:
publication
Title:
Unnamed
Year:
2010
Reference Type:
publication
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
clinical investigations
GLP compliance:
no

Test material

Constituent 1
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

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.