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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
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:
Effective Wound Closure With a New Two-Component Wound, Closure Device (Prineo TM) in Excisional Body-Contouring, Surgery: Experience in Over 200 Procedures
Author:
Huemer, G.M., Schmidt, M., Helmi, G.H., Shafighi, M., Dunst-Huemer, K.M.
Year:
2012
Bibliographic source:
Aesth Plast Surg (2012) 36: 382-386
Reference Type:
publication
Title:
Dermabond Efficacy in Total Joint Arthroplasty Wounds
Author:
Miller, A.G., MD, and Swank M.L., MD
Year:
2010
Bibliographic source:
Am. J. Otrhop. 2010; 39(10): 476-478
Reference Type:
publication
Title:
Paediatric sutureless circumcision-an alternative to the standard technique
Author:
Kelly, B.D., Lundon, D.J., Timlin, M.E., Sheikh, M., Nusrat, N.B., D'Arcy, F.T., Jaffry, S.Q.
Year:
2012
Bibliographic source:
Pediatr.Surg.Int. (2012) 29: 305-308
Reference Type:
publication
Title:
Use of skin glue versus traditional wound closure methods in brain surgery: A prospective, randomized, controlled study
Author:
Chibbaro, S.; Tacconi, L.
Year:
2009
Bibliographic source:
Journal of Clinical Neuroscience 16 (2009) 535-539
Reference Type:
publication
Title:
Use of Dermabond tissue adhesive in hand surgery
Author:
Hancock, N.J., Samuel, A.W.
Year:
2007
Bibliographic source:
Journal of Wound Care 16 (10) 2007, 441-443

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

Species:
human
Strain:
other: not applicable

Test system

Type of coverage:
open
Preparation of test site:
other: not applicable
Vehicle:
other: commercial preparations
Controls:
other: not applicable
Duration of treatment / exposure:
various
Observation period:
various
Number of animals:
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:
From experience in surgery published in literature, it can be concluded that the use of 2-octyl cyanoacrylate (and N-butyl cyanoacrylate) as medical adhesive is successful, safe and well accepted by patients. No adverse health implications with regard to skin irritation have been described in any of the mentioned publications in humans.
Executive summary:

A variety of clinical investigations demonstrate the well-established use of 2-octyl cyanoacrylate (and also N-butyl cyanoacrylate) as effective alternative to conventional sutures in closing surgical incisions in humans. Tissue adhesives are used in different procedures including general surgery, emergency medicine and plastic surgery. The adhesive polymerizes in contact with tissue surfaces in an exothermic reaction in 30-60 sec. From the overall clinical experience, it was concluded that the use of 2-octyl cyanoacrylate is successful, safe and well accepted by patients.

No adverse health implications with regard to skin irritation have been described in any of the mentioned publications. Thus it is very likely that based on an analogy consideration 1-methyl 2-cyanoacrylate is also not irritating to the skin. 1 -Methylheptyl 2 -cyanoacrylate shares the same reaction mechanism as octyl- and butyl 2 -cyanoacrylate and has high structural similarity, justifiying the read-across.