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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 966
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- 16 instead of 20 animals/dose group, no information on ophthalmological examination/neurological endpoints
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Mecrilate
- EC Number:
- 205-275-2
- EC Name:
- Mecrilate
- Cas Number:
- 137-05-3
- Molecular formula:
- C5H5NO2
- IUPAC Name:
- methyl 2-cyanoprop-2-enoate
- Test material form:
- other: polymerised
- Details on test material:
- Poly (Methyl-2-cyanoacrylate)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- ANIMALS:
64 healthy weanling albino rats, 32 females and 32 males
HOUSING:
individually in elevated metal cages
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 d
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- nominal in diet
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- nominal in diet
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- nominal in diet
- No. of animals per sex per dose:
- 8
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- - observation of symptoms indicating toxic or pharmalogic effects
- weekly body weights
- urine analysis during the study
- hematological values, transaminase, blood urea nitrogen, blood glucose and urinalyses at termination after 90 d - Sacrifice and pathology:
- Haematology, urinalysis, histopathology performed after 90 d application
- Other examinations:
- none
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- see "Any other information on results"
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- see "Any other information on results"
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No statistical significant systemic effects observed
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
RESULTS
Symptomatology:
No untoward indications of toxic or pharmalogic effect were noted over the course of the 90 d experminetal period.
Growth:
Mean weekly body weights, weight ranges and survival data show no statistically significant differences in growth between rats recieving poly (methyl 2-cyanoacrylate) in the diet at different levels, and those in the control group.
Clinical:
Hematological values, transaminase, blood urea nitrogen, blood glucose, and urinalyses were not significantly different between the three test groups and the control group upon termination of the 90 d period. Urine analyses were generally within normal limits, and comparable among both control and test groups during the study.
Histopathology:
The lesion sfound in trachea, lungs and livers were of an infectious nature consistent with the average experience in colony disease. Both control and experimental rats presented similar frequency and severity of lesions, with no sex predominating.
Occurrence of renal pathology was scarce, and more frequent in the controls as a group, except for a rare focus of acute tubulonephritis in one rat on the 100 mg/kg bw/d level of the test agent.
Increases in the terminal ovary weights and respective organ/body weight ratios were recorded in females at all three dose levels.
Other weight and ratio increases included the thyroid in both males and females. These weight changes, when viewed in the light of the negative histopathological and clinical findings, suggest a coincidental statistical phenomenon, although a circumstance of subtle endocrine stress remains plausible.
Applicant's summary and conclusion
- Conclusions:
- No statistical significant systemic effects induced by oral administration of poly (methyl 2-cyanoacrylate) over a 90 day period to rats. A NOAEL of >200 mg/kg b.w./d was deduced.
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