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Diss Factsheets
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EC number: 205-275-2 | CAS number: 137-05-3
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity
- Remarks:
- other: in vitro - direct exposure to cell medium
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented medical guideline study with GLP
- Justification for type of information:
- Justification: Butylcyanoacrylate (BUCA) is a structural homologue
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993-3 (1992), Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive 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-cyanoacrylate
- 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, 4 pieces)
- Physical State: Solid
- Color: Amber
- Stability: Highly Stable
- Solubility: Practically Insoluble
(2) NEGATIVE CONTROL ARTICLE
- DMEM Complete
- QC #: LPR-02-10-009-CC
- Physical State: Liquid
- Color: Pink
(3) POSITIVE CONTROL ARTICLE (non-activated assay)
- 3-Methylcholanthrene (3-MCA)
- QC #: CSC-94-03-001-CC
- Physical State: Solid
- Color: Yellow
(4) POSITIVE CONTROL ARTICLE (activated assay)
- N-Nitrosodimethylamine (DMN)
- QC #: CSC-01-08-010-CC
- Physical State: Liquid
- Color: Clear
Constituent 1
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- in vitro test
Administration / exposure
- Route of administration:
- other: in vitro - direct exposure to cell medium
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- other: cell culture medium
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 5-72 h
- Frequency of treatment:
- once
- Post exposure period:
- 4 w
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.2 other: g per 1 mL culture medium
- Remarks:
- Extract
- Dose / conc.:
- 5 other: µg/mL
- Remarks:
- 3-Methylcholanthrene (positive control), non-activated assay
- Dose / conc.:
- 0.5 other: µL/mL
- Remarks:
- N-Nitrosodimethylamine (positive control), activated assay
- No. of animals per sex per dose:
- not applicable
- Control animals:
- other: not applicable
Results and discussion
Any other information on results incl. tables
RESUL TS
The number of foci in the test article groups was not significantly different from the corresponding negative control groups in both non-activated and activated conditions (p>0.05). Cultures exposed to positive control article exhibited a significant increase in the frequency of foci in both activated and non-activated conditions (p<0.05), thus validating the assay.
Parallel Cytotoxicity Assay
Non-activated Assay | Activated Assay | |
Mean Colonies / Plate | Mean Colonies / Plate | |
Negative Control | 85 | 86 |
Positive Control * | 1 | 0 |
Test Article | 91 | 97 |
Morphological Cell Transformation Assay Summary
Non-activated Assay | Activated Assay | |||||
Total Plates | Total Foci | Average Foci | Total Plates | Total Foci | Average Foci | |
Negative Control | 15 | 14 | 0.93 | 15 | 16 | 1.07 |
Positive Control * | 15 | 233 | 15.53 | 15 | 250 | 16.67 |
Test Article | 15 | 14 | 0.93 | 15 | 15 | 1.00 |
* Non-activated Assay: 3 -MCA / Activated Assay: DMN
Applicant's summary and conclusion
- Conclusions:
- The test article is considered to have no significant carcinogenic potential, under the experimental conditions employed.
- Executive summary:
SUMMARY
The test article, Polymerised Indermil (n-butylcyanoacrylate) Disk (Area 64.7cm2 approx, 4g weight, 4 pieces), was tested for its ability to cause morphological transformation of BALB/c-3T3 cells, an indicator of carcinogenic potential. The cell culture medium extract of the test article was tested at the neat concentration in the presence and absence of mammalian metabolic activation (S9). Negative controls (cell culture medium) and appropriate positive control articles (3-Methylcholanthrene (3-MCA): Non-Activated Assay; Nitrosodimethylamine (DMN): Activated Assay) were also tested.
The results indicated that the positive control articles caused a statistically significant increase in the number of morphologically transformed cell foci as compared to their concurrent negative controls validating the functioning of the assay. The number of foci in the test article cultures was not statistically significant compared to the concurrent negative control cultures in the presence and absence of metabolic S9 liver microsomal enzyme activation. Based on these results, the test article is considered to have no significant carcinogenic potential, under the experimental conditions employed.
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