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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles
- Justification for type of information:
- Justification: Butylcyanoacrylate (BUCA) is a structural homologue
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 969
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Repeated oral application to weaning rats
- GLP compliance:
- not specified
- Limit test:
- no
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: polymer powder
- Details on test material:
- - n-butyl cyanoacrylate (CAS 6606-65-1)
- density 0.989 g/mL
- used as polymerized powder (preparation procedure see "any other information on materials and methods")
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- ANIMALS: 49 weaning rats, 26 females and 23 males
FEEDING: rat standard food
WATER: ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: 10 g of rat standard food
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- not applicable
- Duration of treatment / exposure:
- 10 d
- Frequency of treatment:
- daily
- Duration of test:
- 10 d
Doses / concentrationsopen allclose all
- Dose / conc.:
- 400 other: mg
- Remarks:
- in 10 g standard feed
- Dose / conc.:
- 800 other: mg
- Remarks:
- in 10 g standard feed
- Dose / conc.:
- 1 600 other: mg
- Remarks:
- in 10 g standard feed
- Dose / conc.:
- 3 200 other: mg
- Remarks:
- in 10 g standard feed
- Dose / conc.:
- 6 400 other: mg
- Remarks:
- in 10 g standard feed
- No. of animals per sex per dose:
- see "any other information on materials and methods"
- Control animals:
- yes, plain diet
- Details on study design:
- 10 day oral application to weaning rats
Examinations
- Maternal examinations:
- not applicable
- Ovaries and uterine content:
- no
- Fetal examinations:
- not applicable
- Statistics:
- no data
- Indices:
- not applicable
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:not examined. Remark: not applicable
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:not examined. Remark: not applicable
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
All of the food was eaten each day by all of the rats, except in occasional cases where small amounts of food (including cyanoacrylate) remained.
None of the animals died during the course of the study.
Four rats - one male rat from groups B and C and one female rat from groups D and F - were lost during the course of the study and therefore were not included in the data. As noted in Table I, one male rat in Group 0 and one female rat in Group F were not included in the data. The male rat gained less weight than the average of all the male rats studied, while the female rat gained more weight than the average of all the female rats studied. The weights of each of these two rats were more than three standard deviations from the average weights of all rats of that sex and group. Because of this, these two mavericks were not included in the results.
There were no significant differences in the average weights of any of the experimental groups from the control groups for each sex. In the gross and histologic evaluation of the organs and tissues of all the rats, no abnormalities were found to suggest any systemic toxic changes resulting from the ingestion of cyanoacrylate at 0 or 90 days following ingestion of cyanoacrylate polymer powder.
Applicant's summary and conclusion
- Conclusions:
- There was no significant effect on the average weights of any of the experimental groups from the control groups for each sex of weaning rats. There were no gross and histologic toxic effects resulting from the ingestion of cyanoacrylate at 0 or 90 days following ingestion of cyanoacrylate polymer powder.
- Executive summary:
Of six groups of weaning rats, five groups were fed varying levels of BCA polymer powder for 10 days. The rats' weights were evaluated during the ingestion period and for 90 days following ingestion, at which time the animals were killed and examined grossly and microscopically.
The results indicated that in rats, even with very high dosage levels of cyanoacrylate ingestion,
- no lethal dose level was obtained,
- the weight gains of the experimental groups were statistically no different from those of the control group,
- and there were no gross or histologic toxic effects from this ingested cyanoacrylate.
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