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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
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented medical guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993-6 (1994), Biological Evaluation of Medical Devices Part 6: Tests for Local Effects After Implantation
- Qualifier:
- according to guideline
- Guideline:
- other: ASTM Section 13 Vol. 13.01 Medical Devices, Designation: F 981-99, 1999
- GLP compliance:
- yes
- Type of method:
- in vivo
- Endpoint addressed:
- other: Long term IM implantation toxicity
Test material
- Reference substance name:
- Enbucrilate
- EC Number:
- 229-552-2
- EC Name:
- Enbucrilate
- Cas Number:
- 6606-65-1
- Molecular formula:
- C8H11NO2
- IUPAC Name:
- butyl 2-cyanoprop-2-enoate
- Test material form:
- other: rods or liquid
- Details on test material:
- (1) POLYMERISED INDERMIL (n-butylcyanoacrylate, CAS 6606-65-1) RODS
- Lot/Batch #: U02B42, Lab Book Refs: 2696/76-1; Date of Fabrication 29/4/02
- Physical State: Solid
- Color: Amber
- Stability: Highly Stable
- Solubility: Practically Insoluble in aqueous
(2) LIQUID INDERMIL (n-butylcyanoacrylate, CAS 6606-65-1)
- Lot/Batch #: U02B42, Lab Book Refs: 2696/76-1; Date of Fabrication 29/4/02
- Physical State: Liquid
- Color: Amber
- Density: Approx. 1
- Stability: Will polymerize when in contact with most materials
- Solubility: N/A
(3) CONTROL ARTICLE
- Negative Control Plastic, QC Inventory #: CSC-00-07-002-CC
- Physical State: Solid
- Color: White
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- ANIMALS
- 3 New Zealand White rabbits (Oryctolagus cuniculus)
- Sex: 1 male and 2 females
- W eight/Age range: 2.58-2.80 kg / at least 11 weeks old
- Health status: healthy, previously used in other experimental procedures
- Animal selection: selected from a larger pool of animals and examined to ensure lack of adverse clinical signs
- Animal purchase: Millbrook Breeding Labs, Amherst, MA
- Acclimatization: Minimum 5 days, under same conditions as for the actual test
- Animal identification: ear marker
CARE AND MAINTANANCE
- Housing: individually housed
- Cages: suspended stainless steel cages
- Bedding: hardwood chips, P.W.I. Industries, St-Hyacinthe, Quebec, Canada (non-contact)
- Animal room temperature: 68±5°F
- Animal room relative humidity: 30-70%
- Air exchanges per hour: 10 to 15
- Lights: 12-hour light/dark cycle, full spectrum fluorescent lights
- The laboratory and animal rooms were maintained as limited-access facilities.
- Animal rations: TEK 8630 Rabbit Diet, Harlan Teklad, Madison, WI, ad libitum
- Water: tap water, ad libitum
There were no known contaminants present in the feed, water, or bedding expected to interfere with the test data.
Administration / exposure
- Route of administration:
- other: intramuscular implantation or injection
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 26 w
- Frequency of treatment:
- continuous
- Post exposure period:
- not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
up to 4 test article strips / test article injections / negative control strips
Basis:
other: per animal
- No. of animals per sex per dose:
- 1 male and 2 females
- Control animals:
- other: yes, concurrent control article
Results and discussion
- Details on results:
- The results indicated that the solid test article (Polymerised Indermil) was non-toxic (Toxicity Rating of 0.12) and that the liquid test article (Liquid Indermil) was non-toxic (Toxicity Rating of 0.96) when implanted for 26 weeks when compared to control article implant sites.
Any other information on results incl. tables
RESULTS
Animal Weights: All three of the test animals increased in weight.
Clinical Observations: None of the test animals exhibited any signs of toxicity over the course of the study.
Animal | Day 0 | Day 182 | Weight Change | Signs of Toxicity* |
20821 (m) | 2.80 | 4.37 | + 1.57 | None |
20822 (f) | 2.60 | 4.20 | + 1.60 | None |
20824 (f) | 2.58 | 4.62 | + 2.04 | None |
*Summary of Clinical Observations day 0 through day 182, excluding muscle implantation scores
Implantation Site Observations (Macroscopic):
Macroscopic evaluation of the test article implant sites indicated no significant signs of inflammation, encapsulation, hemorrhage, necrosis, or discoloration at the 26 week time period.
Implantation Site Observations (Microscopic):
Microscopic evaluation of the test article implant sites indicated no significant signs of inflammation, fibrosis, hemorrhage, necrosis or degeneration as compared to the control article sites. The toxicity rating for the 26 week time period (average of three animals) of the solid test article was 0.12, indicating non-toxicity. The toxicity rating for the 26 week time period (average of three animals) of the liquid test article was 0.96, indicating non-toxicity.
Applicant's summary and conclusion
- Conclusions:
- The test articles, Polymerised Indermil (n-butylcyanoacrylate) Rods and Liquid Indermil, were implanted or injected in the paravertebral muscle tissue of New Zealand White rabbits for a period of 26 weeks. The results indicated that both, the solid test article and the liquid test article were non-toxic.
- Executive summary:
SUMMARY
The test articles, Polymerised Indermil (n-butylcyanoacrylate) Rods and Liquid Indermil, were implanted or injected in the paravertebral muscle tissue of New Zealand White rabbits for a period of 26 weeks.
The results indicated that the test article, Polymerised Indermil (n-butylcyanoacrylate) Rods, was non-toxic when implanted for 26 weeks (Toxicity Rating of 0.12) when compared to control article implant sites.
The results indicated that the test article, Liquid Indermil, was non-toxic when implanted for 26 weeks (Toxicity Rating 0.96) when compared to control article implant sites.
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