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EC number: 236-102-9 | CAS number: 13162-05-5
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study according to OECD guideline 402
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- low animal number
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-vinylformamide
- EC Number:
- 236-102-9
- EC Name:
- N-vinylformamide
- Cas Number:
- 13162-05-5
- Molecular formula:
- C3H5NO
- IUPAC Name:
- N-vinylformamide
- Details on test material:
- - Lot No.: V 56/92 1. FRAKT.
- Date of manufacturing: 1992-3-19
- Physical state: Liquid, achromatic (at room temperature); solid, crystalline (at about -20°C)
- Storage condition of test material: Deep-freeze; sensitive to hydrolysis (tightly closed); the storage stability of the test substance over the study period was guaranteed by reanalysis
- Analytical purity: >99%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comparable weight (2.0-3.0 kg)
- Housing: Single housing in cages made of stainless steel with wire mesh walk floors; floor area 40 x 51 cm; no bedding in the cages; sawdust in the waste trays
- Diet: Kliba Labordiaet 341, 4 mm (Klingentalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 / 12 (18.00 - 6.00 h dark / 6.00 - 18.00 h light)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: undiluted
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped epidermis (dorsal and dorsolateral parts of the trunk)
- % coverage: at least 10% of the body surface (about 200 cm²)
- Type of wrap if used: four layers absorbent gauze (Ph. Eur. Lohmann GmbH&Co. KG) and Fixomull stretch (Adhesive fleece; Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 1.98 ml/kg bw
- Concentration: undiluted - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. A check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals. Individual reedings for the scoring of skin findings (according to Draize JH, 1959: Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States, Austin, Texas) were performed 30-60 min after removal of the semiocclusive dressing (day 1), weekly thereafter and at the end of the study (last day of observation period). Individual body weights were determined shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- Necropsy of survivors performed: yes (withdrawal of food at least 16 h before killing with CO2; then necropsy with gross pathology examination)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- 1 male after day 1
- Clinical signs:
- other: no abnormalities
- Gross pathology:
- Animal that died (1 male): general congestion; heart: dilation, right ventricle
Sacrificed animals (2 males, 3 females): no pathologic findings - Other findings:
- Scaling of local effects at the readings of days 7 and 14 (males) and day 7 (females).
Any other information on results incl. tables
day 0 | day 7 | day 13 | |
Males | 2.7 | 2.81 | 2.93 |
Females | 2.66 | 2.83 | 2.94 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information criteria for interpretation: EU
- Conclusions:
- The acute dermal LD50 of the test material is >2000 mg/kg bw for male and female rabbits.
- Executive summary:
The study was a GLP-study according to OECD guideline 402 without restrictions.
The acute dermal toxicity of the test substance was investigated in a group of 3 male and 3 female Vienna White rabbits. The test material was applied undiluted to the clipped epidermis (dorsal and dorsolateral parts of the trunk) of each animal at a dose level of 2000 mg/kg bw, and was covered by a semiocclusive dressing for 24 h.
There were no signs of systemic toxicity. After the removal of the dressing no skin reactions could be observed. All animals exhibited scaling of skin findings 7 days after application. This skin reaction persisted in the male animals until study termination (day 14). The expected body weight gain was observed. One male animal died one day after application (no further mortality). Necropsy of the animal that died revealed general congestion and dilation of the right ventricle of the heart. No abnormalities were observed at the end of the study in the surviving animals.
Conclusions: The acute dermal LD50 of the test material is >2000 mg/kg bw for male and female rabbits.
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