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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and 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:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- other: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity; ISO 10993-3 (1992)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Polymerised Indermil
- IUPAC Name:
- Polymerised Indermil
- 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:
- TEST ARTICLE:
- Polymerised Indermil (n-butylcyanoacrylate, CAS 6606-65-1) - Disk (Area 64.7cm2 approx, 4g weight - 2 pieces )
- Lot/Batch Number: U02B41, Lab Book Refs: 2696/74-48; 2696/74-55
- Physical State: Solid
- Color: Amber
- Density: N/S
- Stability: Highly Stable
- Solubility: Practically insoluble
- Expiration Date: N/S
- Storage Conditions: Room Temperature
- Safety Precautions: Standard Toxikon Laboratory Safety Precautions
NEGATIVE CONTROL ARTICLE:
- 0.9% USP Sodium Chloride for Injection (NaCl)
- Toxikon QC#: CSC-02-01-002-VIV
- Physical State: Liquid
- Color: Clear, Colorless
- Storage Conditions: Room Temperature
- Safety Precautions: Standard Laboratory Safety Precautions
POSITIVE CONTROL ARTICLE:
- Mitomycin C (MMC)
- Toxikon QC #: CSC-02-03-017-CC
- Physical State: Solid
- Color: White
- Storage Conditions: 4±2°C
- Safety Precautions: Standard Laboratory Safety Practices
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- ANIMALS:
38 Swiss Albina mice (mus musculus)
- Weight range: 22.9 to 34.6 g (weighed to the nearest 0.1 g)
- Age: at least 6 weeks old (adult)
- Animal Identification: ear punch
- Animal purchase: Harlan, Indianapolis, IN.
- Acclimatization: Minimum 5 days und er the same conditions as for the actual test.
- Animal Selection: selected from a larger pool of animals and examined to ensure lack of adverse clinical signs.
CARE AND MAINTENANCE:
- Housing: group housing (5 of same sex/cage)
- Cages: polycarbonate cages
- Bedding: hardwood chips (contact): P.W.I. Industries, St-Hyacinthe, Quebec, Canada
- 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 7012, Rodent Diet, Harlan Teklad, Madison, WI
- 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:
- intravenous
- Vehicle:
- NaCl
- Duration of treatment / exposure:
- single injection
- Frequency of treatment:
- once
- Post exposure period:
- 24h and 48h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50mL/kg bw
Basis:
other: extract in NaCl (0.2g/mL)
- No. of animals per sex per dose:
- TOTAL: 19 males and 19 females
- TEST: 10 each (5 males and 5 females) for 24h or 48h
- NEGATIVE CONTROL: 6 each (3 males and 3 fmeales) for 24h or 48h respectively
- POSITIVE CONTROL: 6 (3 males and 3 fmeales) for 24h - Control animals:
- yes
- Positive control(s):
- Mitomycin C (200 µg/kg bw, dissolved in NaCl) intraperitoneal
Examinations
- Tissues and cell types examined:
- bone marrow (femur) / erythrocytes
- Evaluation criteria:
- EVALUATION: The number of micronucleated polychromatic erythrocytes for the positive and negative controls should be in the range of expected historical control values. The frequency of micronucleated PCEs in the positive control group should be statistically significantly greater than the negative control group. If these conditions are not met the test should be repeated.
POSITIVE RESPONSE: The test article was considered to have caused a positive response in the assay if the test article had exhibited a reproducible and statistically significant increase over its concurrent negative control article. - Statistics:
- Data was analyzed separately for male and female animals. The frequency of micronucleated PCEs in each dose group was compared to that in the respective negative control and to each other using the program: "Newman-Keuls Test" by R.J. Tallarida and R.B. Murray, (Manual of Pharmacologic Calculations with Computer Programs, Springer-Verlag, New York, 1986, pp. 121- 125). Biological and statistical significance was considered in the evaluation. Results were considered not significant with p>=0.05.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- lethargy and clonic convulsions immediately after injections only
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
ANIMAL WEIGHTS, DOSING AND CLINICAL OBSERVATIONS:
Animal weight (prior to dosing and prior to sacrifice), dosing data and clinical observations were recorded for all the animals, during the course of the study. All animals had gained weight at the time of sacrifice.
Eight Animals out of the test article group showed signs of lethargy and clonic convulsions immediately after injections. These signs of clinical toxicity were resolved by the 24-hour observation and did not impact on the mutagenicity properties of the test article. No other clinical signs of toxicity were observed for any of the test or control animals.
MICRONUCLEUS SCORING:
There was a statistically significant increase in the number of micronucleated cells in the positive control group, as compared to the negative control group, thus validating the conduct of the assay.
There was no statistically significant increase in the number of micronucleated cells in the test article extract group at all time points, as compared to the concurrent negative control groups.
AVERAGE RESULTS PER GROUP
Group |
PCE |
NCE |
PCE/NCE |
MNC |
MNC/PCE |
Weight change |
Test article 24h (male) |
2000 |
1675 |
1.20 |
4.20 |
0.0021 |
+ 2.04 g |
Test article 24h (female) |
2000 |
1637 |
1.23 |
4.00 |
0.0020 |
+ 1.76 g |
Test article 48h (male) |
2000 |
1626 |
1.23 |
4.40 |
0.0022 |
+ 2.12 g |
Test article 48h (female) |
2000 |
1603 |
1.25 |
4.60 |
0.0023 |
+ 1.54 g |
Negative control 24h (male) |
2000 |
1614 |
1.24 |
5.00 |
0.0025 |
+ 1.50 g |
Negative control 24h (female) |
2000 |
1667 |
1.20 |
4.67 |
0.0023 |
+ 1.67 g |
Negative control 48h (male) |
2000 |
1745 |
1.15 |
5.67 |
0.0028 |
+ 2.00 g |
Negative control 48h (female) |
2000 |
1656 |
1.21 |
5.33 |
0.0027 |
+ 1.37 g |
Positve control 24h (male) |
2000 |
1979 |
1.02 |
57.33 |
0.0287 |
+ 1.90 g |
Positve control 24h (female) |
2000 |
2181 |
0.92 |
62.00 |
0.0310 |
+ 1.67 g |
PCE: Polychromatic Erythrocytes
NCE: Normochromatic Erythrocytes
MNC: Micronucleated Cells
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test article, Polymerised Indermil (n-butylcyanoacrylate), is considered non-mutagenic, under the experimental conditions utilized. - Executive summary:
SUMMARY
The extract of the test article was tested for its ability to induce a statistically significant increase in the number of micronucleated cells in rodent bone marrow. The 0.9% USP Sodium Chloride for Injection (NaCl) extract of the test article, Polymerised Indermil (n-butylcyanoacrylate), was tested at the neat concentration, and did not induce a statistically significant increase in micronucleated cells as compared to the negative control at 24 and 48 hours after dosing. The positive control, Mitomycin C, caused a statistically significant increase in micronucleated cells as compared to the negative control.
Based on the criteria ofthe study protocol, the test article, Polymerised Indermil (n-butylcyanoacrylate), is considered non-mutagenic, under the experimental conditions utilized.
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