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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
Endpoint summary
Administrative data
Description of key information
SKIN IRRITATION:
- REACH_slightly irritating | rabbit | OECD 404 | LID-1187A #key study#
EYE IRRITATION:
- REACH_Lit_well tolerated | rabbit | Toxicity study of Butyl
2-Cyanoacrylate (Alejo et al) |
- REACH_Lit_improvement of healing process | rabbit | Use of n-butyl
cyanoacrylate for corneal rhaphy (Mota et al) |
- REACH_Lit_acceptable inflammatory reaction | rabbit | Tissue Adhesives
for a Sutureles Fadenoperation (Tonelli et al) |
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Various studies are available to assess the acute dermal irritation/corrosion of n-butyl cyanoacrylate in rabbits. The substance was directly tested on non-abraded and abraded skin. Cured patches were also tested on non-abraded and abraded skin. Moreover, extracts of cured material were evaluated for their potential to produce irritation after intracutaneous injection according to ISO 10993-10 (1996), Biological Evaluation of Medical Devices Part 10: Irritation and Sensitization Test.
As the OECD guideline 404 requires testing of substances on intact skin, those studies are ranked highest in quality. The test with fresh, uncured material reflects the realistic exposure situation on skin best and is thus judged to be the key study.
Under the conditions of this test, direct application of n-butyl cyanoacrylate was considered to be 'slightly irritant' to intact skin. The classification criteria under CLP are not fulfilled.
Eye irritation
The safety of n-butyl cyanoacrylate has not been tested on corneal tissue specifically with regard to eye irritation as described under the international OECD standard guideline. However, some medical investigations on rabbit eyes have been conducted in order to proof the suitability of this substance as tissue glue for repairing injuries on the eye (Alejo, 1973, Mota, 2004, Tonelli, 2004). The studies concluded that n-butyl cyanoacrylate is well tolerated basically in contact with cornea. No irritation is described. Some cytotoxic reactions have been observed as well as inflammatory responses; however, it needs to be considered that the rabbit eyes have been severely injured before application of the glue. Use of the glue for proof of compatibility would have been unfeasible in case of irritating properties of n-butyl cyanoacrylate. It is thus concluded, based on the weight-of-evidence from the rabbit experiments, that this substance is not irritating to rabbit’s eyes.
Moreover, much experience from clinical observations and investigations in humans is available (see also summary of supportive data in chapter 7.10).
Various authors describe that the use of n-butyl cyanoacrylate (as well as the structural analogue isobutyl cyanoacrylate) offers a safe technique for healing corneal wounds and is an effective alternative to classical sutures (e.g. in scleral tunnel cataract surgery or for treatment of corneal perforations). The case reports and clinical studies describe a direct application of the adhesive onto the eye (cornea) which gives an indication on the compatibility of the tissue adhesive on eyes. It is summarized that n-butyl cyanoacrylate can well be used as wound barrier in ocular surgery with a low side effect profile. Irritation was not mentioned in any of the publications as contraindication for the use of n-butyl cyanoacrylate in eye surgery.
The overall weight-of-evidence taken from a literature search on the use of n-butyl cyanoacrylate as tissue adhesive in ocular surgery in rabbits and humans indicates that this substance is very likely not irritating to eyes.
Justification for selection of skin irritation / corrosion
endpoint:
see discussion section
Justification for selection of eye irritation endpoint:
see discussion section
Effects on skin irritation/corrosion: slightly irritating
Justification for classification or non-classification
Skin irritation
Based on the overall weight-of-evidence resulting from investigations on n-butyl cyanoacrylate in OECD and ISO standard tests, it is concluded that n-butyl cyanoacrylate is not classified as irritating to the skin.
Eye irritation
The overall weight-of-evidence taken from a literature search on the use of n-butyl cyanoacrylate as tissue adhesive in ocular surgery in rabbits and humans indicates that this substance is very likely not irritating to eyes.
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