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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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- 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:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993-11 (1993), Biological Evaluation of Medical Devices Part 11: Test for Systemic Toxicity
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993-12 (1997), Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials
- GLP compliance:
- yes
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: extract
- Details on test material:
- (1) POLYMERISED INDERMIL (n-butylcyanoacrylate, CAS 6606-65-1) DISK (Area 64.7cm2 approx, 4g weight - 2 pieces):
- Lot/Batch #: U02B51, Lab Book Refs: 2696/75-85; 2696/75-86
- Physical State: Solid
- Color: Amber
- Stability: Highly Stable
- Solubility: Practically Insoluble
(2) CONTROL ARTICLE 1:
- 0.9% USP Sodium Chloride for Injection (NaCl)
- QC Inventory #: CSC-02-01-002-VIV
- Physical State: Liquid
- Color: Clear
(3) CONTROL ARTICLE 2:
- Cottonseed Oil (CSO)
- QC Inventory #: CSC-02-03-003-VIV
- Physical State: Liquid
- Color: Yellow
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- ANIMALS
- 20 Albino Swiss mice (Mus musculus)
- Sex: male
- Weight/Age range: 17.2 - 20.6 grams / at least 34 days old (adult)
- Health Status: healthy, not previously used in other experimental procedures
- Animal Identification: ear punch
- Animal Purchase: Harlan, Indianapolis, IN.
CARE AND MAINTANANCE
- Housing: group housed (5 mice of same sex)
- Bedding: hardwood chips, (contact), P.W.I. Industries, St-Hyacinthe, Quebec, Canada
- Acclimatization: minimum 5 days under the same conditions as for the actual test
- 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
- Animal rations: TEK 7012, Rodent Diet, Harlan Teklad, Madison, WI, ad libitum
- Water: tap water, ad libitum
- The laboratory and animal rooms were maintained as limited-access facilities
- Animal Selection: chosen from larger pool and examined for lack of adverse clinical signs
- 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: intravenous or intraperitoneal
- Vehicle:
- other: physiol. saline or cotton seed oil
- Doses:
- 50 mL/kg bw of Extract of 0.2g Polymerised Indermil per 1 mL vehicle (24h at 70±2°C)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
Results and discussion
Any other information on results incl. tables
RESULTS
Animal Weights
All of the test and control animals increased in weight.
Clinical Observations
None of the test or control animals exhibited overt signs of toxicity at any of the observation points.
The test is considered negative because none of the animals injected with the extracts of the test article showed a significantly greater biological reaction than the animals treated with the control articles.
Group |
Animal (Sex) |
Weight change (g) |
Signs of Toxicity |
NaCl / Test |
1 (m) |
2.2 |
none |
NaCl / Test |
2 (m) |
2.2 |
none |
NaCl / Test |
3 (m) |
1.8 |
none |
NaCl / Test |
4 (m) |
2.4 |
none |
NaCl / Test |
5 (m) |
2.3 |
none |
NaCl / Control |
6 (m) |
2.3 |
none |
NaCl / Control |
7 (m) |
2.5 |
none |
NaCl / Control |
8 (m) |
1.8 |
none |
NaCl / Control |
9 (m) |
2.6 |
none |
NaCl / Control |
10 (m) |
2.3 |
none |
CSO / Test |
11 (m) |
2.5 |
none |
CSO / Test |
12 (m) |
1.8 |
none |
CSO / Test |
13 (m) |
2.4 |
none |
CSO / Test |
14 (m) |
1.6 |
none |
CSO / Test |
15 (m) |
2.4 |
none |
CSO / Control |
16 (m) |
1.8 |
none |
CSO / Control |
17 (m) |
1.7 |
none |
CSO / Control |
18 (m) |
1.7 |
none |
CSO / Control |
19 (m) |
2.2 |
none |
CSO / Control |
20 (m) |
2.3 |
none |
Applicant's summary and conclusion
- Conclusions:
- This test is considered negative.
- Executive summary:
SUMMARY
The 0.9% USP Sodium Chloride for Injection (NaCl) and Cottonseed Oil (CSO) extracts of the test article, Polymerised Indermil (n-butylcyanoacrylate) Disk, did not induce a significantly greater biological reaction than the control articles, when tested in Albino Swiss mice.
This test is considered negative based on standards set by the study protocol.
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