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EC number: 213-103-2 | CAS number: 924-42-5
- 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:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented report of a guideline study conducted to GLP.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: NTP 16-day oral toxicity study by gavage in rodents
- Principles of method if other than guideline:
- Dose range-finding study prior to chronic studies in rodents.
- GLP compliance:
- yes
- Test type:
- other: 16 day gavage
- Limit test:
- no
Test material
- Reference substance name:
- N-(hydroxymethyl)acrylamide
- EC Number:
- 213-103-2
- EC Name:
- N-(hydroxymethyl)acrylamide
- Cas Number:
- 924-42-5
- Molecular formula:
- C4H7NO2
- IUPAC Name:
- N-(hydroxymethyl)acrylamide
- Details on test material:
- - Name of test material (as cited in study report): N-Methylolacrylamide
- Substance type: Non-volatile, organic
- Physical state: Solid
- Analytical purity: approximately >98%
- Impurities (identity and concentrations): unkown but evidence indicates that 1% may have been a polymer of Nmethylolacrylamide,
which would not have been detected by the analytical methods used
- Composition of test material, percentage of components: 100%
- Isomers composition: not applicable
- Purity test date: no data
- Lot/batch No.: 1-45-000
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: storage at 5°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries
- Age at study initiation: approximately 7 weeks old
- Weight at study initiation: 147 ± 4 g for males ; 115 ± 5 g for females
- Fasting period before study: no data
- Housing: 5 per cage
- Bedding: Absorb-Dri, Inc., Garfield, NJ
- Diet: ad libitum
- Feed: NIH 07 Rat and Mouse Ration (Zeigler Bros., Inc., Gardners, PA)
- Water: ad libitum (automatic watering system)
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 07/04/1981 To: 23/07/1981
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 5
- Justification for choice of vehicle: substance is totally water soluble
- Purity: deionised
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg
- Rationale for the selection of the starting dose: Based on acute toxicity of acrylamide - Doses:
- 0,25, 50, 100,200, or 400 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: none (16 day study)
- Frequency of observations and weighing: observation two times per day and weighing on days 1 and 7 and at necropsy
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 400 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All rats that received 400 mg/kg died within 4 days, and 3/5 male rats and 2/5 female rats that received 200 mg/kg also died before the end of the study.
- Clinical signs:
- other: No abnormal clinical observations were noted in the study.
- Gross pathology:
- Compound related lesions in rats included hyperplasia of the bronchiolar and tracheal epithelium, dysplasia of the nasal and tracheal epithelium, centrilobular hepatocellular necrosis, lymphoid depletion of the spleen, and myelin degeneration of the lumbar ventral spinal nerve. Bronchial epithelial hyperplasia (mild) appeared to be dose related in males and females. Sinusoidal congestion of the liver and vacuolar degeneration of myocardial fibers were seen in males and females given 400 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the acute oral LD50 of N-methylolacrylamide in the Fischer rat is between 200 and 400 mg/kg bw.
- Executive summary:
-
Test condition :Groups of 5 rats per sex were dosed with 50, 100, 200, 400 or 800 mg/kg.
Male rats ranged form 101-128 g starting body weight, females weighed
from 84-102 g at the study initiation. Animals received a single dose in a
concentration 5.0 ml/kg. Animals were observed twice a day for clinical
signs. After 14 days observation, surviving animals were terminated
without necropsy or histopathology. No clinical pathology was performed.
Result :All rats in the 800 mg./kg group died on or before Day 2. In the 400 mg/kg
group, four males and three females died during the first week of
observation. No abnormal clinical signs were noted.
Conclusion :LD50 = 400 mg/kg
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