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EC number: 221-698-5 | CAS number: 3195-78-6
- 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:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Pregnant female rats were treated by dermal application from day 7 to day 16 of gestation
On gestation day 21 rats were sacrified and foetuses were removed by cesarean
Maternal examinations: Cage side observation, body weight, food consumption, organ examination
Fetal examinations: body weight, sex ration, still birth/growth retarded feteouses, external examination, soft tissue examination, skeletal examination
Further investigations: number of pregnancy, resorption rate, litter size - GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Limit test:
- no
Test material
- Reference substance name:
- N-methyl-N-vinylacetamide
- EC Number:
- 221-698-5
- EC Name:
- N-methyl-N-vinylacetamide
- Cas Number:
- 3195-78-6
- Molecular formula:
- C5H9NO
- IUPAC Name:
- N-ethenyl-N-methylacetamide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SPF Wistar K
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: centraal proefdierendedrijf (central laboratory animal market) TNO, Zeist, Netherlands
- Weight at study initiation: 189g
- Housing: after cohabitation individual housing
- Diet: Altromin VM 1025, ad libitum
- Drinking: tap water, ad libitum
- Temperature: 22-23°C
- Humidity: 55-60%
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- water
- Remarks:
- bidestillated
- Details on exposure:
- TEST SITE
- Area of exposure: on the clipped back and flank - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Length of cohabitation: over night
- Proof of pregnancy: sperm in vaginal smear referred to as day 1 of pregnancy - Duration of treatment / exposure:
- day 7 to day 16 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- until gestation day 21
Doses / concentrationsopen allclose all
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- Remarks:
- 0.08 mL
- Dose / conc.:
- 800 mg/kg bw/day (nominal)
- Remarks:
- 0.16 mL
- Dose / conc.:
- 1 600 mg/kg bw/day (nominal)
- Remarks:
- 0.32 mL
- Dose / conc.:
- 3 200 mg/kg bw/day (nominal)
- Remarks:
- 0.63 mL
- No. of animals per sex per dose:
- 20 female animals
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once per day
BODY WEIGHT: Yes
- Time schedule for examinations: once per day
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: Yes - Ovaries and uterine content:
- - On gestation day 21 rats were sacrified and foetuses were removed by cesarean
- The uterus and uterine content was examined after termination: Yes
Examinations included:
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes (50% of the foetuses), fixed in Bouin´sche solution followed by makroskopic examination (cross section analysis)
- Skeletal examinations: Yes (50% of the foetuses), fixed in 70% alcohol, dissected, eviscerated, brightened in KOH and dyed in Alizarinred S
- Head examinations: no data - Statistics:
- no data
- Indices:
- number of pregnancy, resorption rate, litter size, body weight, sex ration, still birth/growth retarded feteouses
- Historical control data:
- no data
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 1600 mg/kg bw/day and 3200 mg/kg bw/day: coat sparse and anaemic acren
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 1600 mg/kg bw/day: 1/20
3200 mg/kg bw/day: 8/20 - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 800 mg/kg bw/day: only slight influences
1600 mg/kg bw/day: body weight increased only slightly
3200 mg/kg bw/day: body weight decreased - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- 800 mg/kg bw/day and 1600 mg/kg bw/day: reduced food consumption during the first treatment days
3200 mg/kg bw/day: reduced food consumption during the treatment period - Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Description (incidence and severity):
- No organ abnormalities.
Bloody secretion in abdominal cavity and thoracic cavity, light brown liquid in liver and stomach. - Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- effects observed, treatment-related
- Description (incidence and severity):
- 400 mg/kg bw/day: no effect
800 mg/kg bw/day: resorptions instead of fetuses in 2/20* animals
1600 mg/kg bw/day: resorptions instead of fetuses in 7/19* animals
3200 mg/kg bw/day: resorptions instead of fetuses in 7/10* animals
Control group: resorptions instead of fetuses in 1/18* animals
* animal pregnant and survived until gestation day 21. Dose-dependent increased resorption rate also seen in delivering animals, especially in the 800 mg/kg bw/day, 1600 mg/kg bw/day, 3200 mg/kg bw/day dose group. - Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- effects observed, treatment-related
- Description (incidence and severity):
- 3200 mg/kg bw/day: Pregnancy did not occur in 10/20 animals despite sperm in vaginal smear
Control group: Pregnancy did not occur in 2/20 animals despite sperm in vaginal smear - Other effects:
- no effects observed
- Description (incidence and severity):
- Placenta: size and macroscopic examinations were considered to be within a normal range.
Effect levels (maternal animals)
- Basis for effect level:
- other: effect type not specified
- Remarks on result:
- other: No NOAEL derived.
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 400 mg/kg bw/day: slightly decreased body weight (within the normal range)
800 mg/kg bw/day: slightly decreased body weight (within the normal range)
1600 mg/kg bw/day: markly decreased body weight
3200 mg/kg bw/day: markly decreased body weight
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- effects observed, treatment-related
- Description (incidence and severity):
- Still birth/growth retarded fetuses:
400 mg/kg bw/day: within the normal range
800 mg/kg bw/day: within the normal range
1600 mg/kg bw/day: within the normal range
3200 mg/kg bw/day: increased - Changes in sex ratio:
- effects observed, treatment-related
- Description (incidence and severity):
- 400 mg/kg bw/day: balanced and within the normal range
800 mg/kg bw/day: balanced and within the normal range
1600 mg/kg bw/day: balanced and within the normal range
3200 mg/kg bw/day: increased number of male offspring - Changes in litter size and weights:
- effects observed, treatment-related
- Description (incidence and severity):
- 400 mg/kg bw/day: comparable to control group
800 mg/kg bw/day: decreased in relation to increased resorption rate
1600 mg/kg bw/day: decreased in relation to increased resorption rate
3200 mg/kg bw/day: decreased in relation to increased resorption rate - Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Description (incidence and severity):
- No external abnormalities and no organ abnormalities appeared in fetuses used for skeletal examination.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- 400 mg/kg bw/day: within the normal range
800 mg/kg bw/day: within the normal range
1600 mg/kg bw/day: within the normal range
3200 mg/kg bw/day: within the normal range - Visceral malformations:
- not specified
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Cross section analysis:
Fetuses with oneside microphthalmia and anophthalmos:
400 mg/kg bw/day: 1%
800 mg/kg bw/day: 3.6%
1600 mg/kg bw/day: 6.4%
3200 mg/kg bw/day: 14.3%
Control group: 1.1%
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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