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Diss Factsheets
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EC number: 230-796-7 | CAS number: 7324-02-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Well documented study with GLP, comparable to OECD-guideline
- Justification for type of information:
- Butyl 2-cyanoacrylate (enbucrilate) and allyl 2-cyanoacrylate are structural homologs, they have comparable physicochemical properties, similar predicted structural binding capacities, identified structural alerts, predicted metabolism (see attached justification).
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: Irritation and Sensitization Test, EN/ISO 10993-10 (1996)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed prior to OECD 429 guideline; standard procedure for testing of medical devices.
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 - 2 pieces)
- Lot/Batch #: U02B41, Lab Book Refs: 2696/73-41; 2696/73-42;
- Physical State: Solid
- Color: Amber
- Solubility: Practically Insoluble
(2) CONTROL ARTICLE:
- 0.9% USP Sodium Chloride For Injection (NaCl)
- QC Inventory #: CSC-02-01-002-VIV
- Physical State: Liquid
- Color: Clear
(3) CONTROL ARTICLE:
- Cottonseed Oil (CSO)
- QC Inventory #: CSC-02-03-003-VIV
- Physical State: Liquid
- Color: Yellow
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Details on test animals and environmental conditions:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- cotton seed oil
- Concentration / amount:
- - Article extract: 3 cm2 per 1 mL CSO
- Primary irritation test: Article extract 100% and 75% (diluted in CSO)
- Application: Article extract 100%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- - Article extract: 3 cm2 per 1 mL CSO
- Primary irritation test: Article extract 100% and 75% (diluted in CSO)
- Application: Article extract 100%
- No. of animals per dose:
- 5 males, 5 females
- Details on study design:
- ANIMALS:
- 7 males, 10 females
- Weight/Age range: 374.3 - 432.6 grams, at least 26 days old (adult)
- Health status: healthy, not previously used in other experimental procedures
- Animal purchase: Elm HilI Breeding Labs, Inc., Chelmsford, MA
- Animal identification: ear punch
- Acclimatization: minimum 5 days under the same conditions as for the actual test
- Animal selection: chosen from larger pool and examined for lack of adverse clinical signs
CARE & MAINTANANCE:
- 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
- Housing: group housed
- Cages: suspended stainless steel
- Bedding: hardwood chips, P.W.L Industries, St-Hyacinthe, Quebec, Canada (non-contact)
- Animal rations: TEK Hi-Fiber Guinea Pig Diet 2041, 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.
- The laboratory and animal rooms were maintained as limited-access facilities. - Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene (DNCB)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100% CSO
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% CSO
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% CSO
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100% Test article extract in CSO
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% Test article extract in CSO
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% Test article extract in CSO
- Total no. in group:
- 10
- Clinical observations:
- none
Any other information on results incl. tables
RESULTS
- Animal Weights: All animals gained in body weight.
- Clinical Observations: No systemic signs of toxicity were observed in treated or control animals.
- Sensitization: None of the treated (CSO extract) or negative control animals (CSO) exhibited any reaction to the challenge (0% sensitized).
- Historical positive control: animals have exhibited skin reactions of 1, 2 or 3 at each observation point (100% sensitized).
Primary Irritation Test - Reactions
Animal # | Dose | Erythema/Edema | Erythema/Edema | Signs of toxicity |
16/F | 100% intradermal | 0/0 | 0/0 | none |
16/F | 75% intradermal | 0/0 | 0/0 | none |
17/F | 100% topical | 0/0 | 0/0 | none |
17/F | 75% topical | 0/0 | 0/0 | none |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the standards set by the study protocol, the Cottonseed Oil (CSO) extract of the test article, Polymerised Indermil (n-butylcyanoacrylate), elicited no reaction at the challenge (0% sensitization), following an induction phase. Therefore, as defined by the scoring system of Kligman, this is a Grade I reaction and the test article is classified as having weak allergenic potentiaL. A Grade I sensitization rate is not considered significant according to Magnusson and Kligman (1969, 1970).
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