Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-845-1 | CAS number: 133978-15-1
Skin irritation / corrosion
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:
- 2 012
- 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:
- 2 010
- 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:
- 2 012
- 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:
- 2 009
- 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:
- 2 007
- 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
- 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
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
