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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31. May 2005 - 21. Sep 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
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:
- - Name of test material (as cited in study report): N-VINYLFORMAMIDE
- Analytical purity: 99.1 area-% (
- Lot/batch No.: Pr. Nr. 71500
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility .
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd Laboratory Animal Services, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland.
- Age at study initiation: Young adult animals (female animals approx. 8- 12 weeks).
- Weight at study initiation: 179 g (mean)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG).
- Diet: Kliba-Labordiät (Maus / Ratte Haltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 a .m. - 6 .00 p.m. / 6 .00 p.m. - 6.00 a .m.)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.93 ml/kg
- Doses:
- 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study . Additionally, at day of death in animals that died or were sacrificed moribund starting with study day 1. Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 000 - 2 000 mg/kg bw
- Mortality:
- Four animals of the 2000 mg/kg administration groups and one animal of the 1000 mg/kg administration groups were found dead on study days 1 and 2, respectively.
- Clinical signs:
- other: Clinical observation in the 2000 mg/kg administration groups revealed impaired and poor general state, dyspnoea, lateral position, staggering, piloerection, salivation and lacrimation and were observed from hour 0 until including study day 6 after adminis
- Gross pathology:
- The following macroscopic pathologic findings were observed in the animals that died:
- Few (2-5) or several (6-10), black erosions/ulcers in the glandular stomach, diameter 1 mm or up to 4 mm (2,000 mg/kg: 4 females).
- Slight red or red discoloration of contents of the small intestine (2,000 mg/kg: 2 females).
- Many (>10), black erosions/ulcers in the glandular stomach, diameter 1 mm; dark red discoloration of contents of the large intestine; red discoloration of the small intestine; beige discoloration of the liver (1,000 mg/kg: 1 female).
No macroscopic pathologic abnormalities were noted in the animals examined at termination of the study (2,000 mg/kg: 2 females; 1,000 mg/kg: 5 females).
Any other information on results incl. tables
Mortality:
Dose (mg/kg bw) |
1000 |
2000 |
||
Administration |
1 |
2 |
1 |
2 |
No. of animals |
3 |
3 |
3 |
3 |
|
||||
after |
|
|
|
|
day 1 |
0 |
0 |
0 |
2 |
day 2 |
0 |
1 |
1 |
3 |
day 14 |
0 |
1 |
1 |
|
Mortality |
1 / 6 |
4 / 6 |
Maximum incidence (and maximum duration) of clinical findings:
Dose (mg/kg bw) |
1000 |
2000 |
||
Administration |
1 |
2 |
1 |
2 |
No. of animals |
3 |
3 |
3 |
3 |
|
||||
Impaired general state |
3 (h0-d1) |
3 (h0-d5) |
3 (h0-d6) |
3 (h0-h4) |
Poor general state |
-
|
-
|
-
|
1 (d1) |
Dyspnoea |
3 (h0-d1) |
3 (h0-d5) |
3 (h0-d6) |
3 (h0-d1) |
Lateral position |
-
|
-
|
-
|
1 (d1) |
Staggering |
3 (h2-d1) |
2 (h3-d1) |
1 (h1-d1) |
3 (h0-h4) |
Piloerection |
3 (d1) |
1 (d1-d2) |
3 (d1-d6) |
- |
Salivation |
3 (h1-h3) |
2 (h0-h2) |
3 (h0-h4) |
3 (h0-d1) |
Lacrimation |
2 (h1-h2) |
3 (h1-d1) |
3 (h0-h3) |
3 (h0-d1) |
Individual body weights:
Dose 1000 mg/kg bw, Administration 1 |
||||
Weightday |
0 |
7 |
14 |
at death |
Animal 994 |
181 |
196 |
211 |
|
Animal 995 |
183 |
191 |
205 |
|
Animal 996 |
179 |
182 |
217 |
|
|
||||
Dose 1000 mg/kg bw, Administration 2 |
||||
Weightday |
0 |
7 |
14 |
at death |
Animal 118 |
180 |
|
|
169 (d2) |
Animal 119 |
182 |
193 |
215 |
|
Animal 120 |
183 |
204 |
217 |
|
|
||||
Dose 2000 mg/kg bw, Administration 1 |
||||
Weightday |
0 |
7 |
14 |
at death |
Animal 010 |
174 |
|
|
163 (d2) |
Animal 011 |
170 |
175 |
194 |
|
Animal 012 |
171 |
187 |
201 |
|
|
||||
Dose 2000 mg/kg bw, Administration 2 |
||||
Weightday |
0 |
7 |
14 |
at death |
Animal 043 |
180 |
|
|
175 (d2) |
Animal 044 |
179 |
|
|
177 (d1) |
Animal 045 |
181 |
|
|
168 (d1) |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information criteria for interpretation: EU/GHS
- Conclusions:
- Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 1000 mg/kg bw and less than 2000 mg/kg bw in rats.
- Executive summary:
The study is reliable without restriction (GLP-study according to OECD guideline 423).
Single doses of 2000 and 1000 mg/kg bw of the unchanged test material were given to four administration groups of three fasted female Wistar rats, each, by gavage in a sequential manner. After administration a 14 -day observation period followed.
Four animals of the 2000 mg/kg administration groups and one animal of the 1000 mg/kg administration groups were found dead from study day 1 until including study day 2.
Clinical observation in the 2000 mg/kg administration groups revealed impaired and poor general state, dyspnoea, lateral position, staggering, piloerection, salivation and lacrimation. Findings were observed from hour 0 until including study day 6 after administration. Clinical observation in the 1000 mg/kg administration groups revealed impaired general state, dyspnoea, staggering, piloerection, salivation and lacrimation. Findings were observed from hour 0 until including study day 5 after administration.
The mean body weights of the surviving animals of the administration groups increased throughout the study period.
During necropsy findings in the animals that died in the 2000 mg/kg and 1000 mg/kg administration groups comprised few, several or many black erosions/ulcers in the glandular stomach and red or slight red discoloration of contents of the small intestine. In addition one animal of the 1000 mg/kg administration group that died showed dark red discoloration of contents of the large intestine and beige discoloration of the liver. No macroscopic pathologic abnormalities were noted in the surviving animals of the 2000 mg/kg and 1000 mg/kg administration groups examined at the end of the observation period.
Conclusion: Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 1000 mg/kg bw and less than 2000 mg/kg bw in rats.
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