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EC number: 218-638-5 | CAS number: 2210-25-5
- 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
Endpoint summary
Administrative data
Description of key information
When a fixed slope of 8.333 was assumed the acute median lethal oral dose of isopropyl acrylamide and its 95% confidence limits were estimated to be:
Males and females combined: 383 (322 to 454) mg/kg bodyweight
Males only: 383 (300 to 487) mg/kg bodyweight
Females only: 383 (300 to 487) mg/kg bodyweight
Based on the conclusion the final LD50 value is concluded as 383 mg/kg/day.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 January 1990 - 20 February 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: GLP, The United Kingdon Compliance Programme, Department of Health and Social Security 1986 and subsequent revision, Department of Health, 1989
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. FDA, Title 21 Code of Federal Regulations Part 58, Federal Register, 22 December 1978 and subsequent Amendments
- Qualifier:
- according to guideline
- Guideline:
- other: United States Environmental Protection Agency, (TSCA) Title 40 Code of Federal Regulations Part 792, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
- Qualifier:
- according to guideline
- Guideline:
- other: Japan Ministry of Health and Welfare Nitification No. Yakuhatsu 313 Pharmaceutical Affairs Bureau, 31 March 1982 and subsequent amandment Notification No. Yakuhatsu 870, Pharmaceutical Affairs Bureau, 5 October 1988
- Qualifier:
- according to guideline
- Guideline:
- other: Japan Ministry of Agriculture, Forestry and Fisheries, 59 NohSan, Notification No. 3850, Agricultural Production Bureau, 10 August 1984
- Qualifier:
- according to guideline
- Guideline:
- other: OECD ISBN 92-64-12367-9, Paris 1982
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Purity: 99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 °C in the dark - Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 108 - 150 g
- Housing: in groups up to 5 rats of the same sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days prior to the start of the main study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22 °C
- Humidity (%): Mean 58 %RH
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours - Route of administration:
- other: Syringe and plastic catheter
- Doses:
- Preliminary study:
groups of two male asnd female rats were dosed at 400 and 1000 mg/kg
Main study:
groups of five male asnd female rats were dosed at 250, 400 and 640 mg/kg - No. of animals per sex per dose:
- Preliminary study:
2 rats per sex per dose
Main Study:
5 rats per sex per dose - Details on study design:
- - Duration of observation period following administration: 5 and 14 days
- Frequency of observations and weighing: twice a day (morning and at the end of the experimental day)
- Necropsy of survivors performed: yes - Statistics:
- The data obtained from this study did not permit the fitting of a probit line using the standard method. However, it was possible to fit a line if a fixed slope was assumed; a value of 8.333 (estimated from background data which consisted of the average slope for all LD50's carried out in the Department of Industrial Toxicology over a period of one year) was used. Confidence intervals using this approach should be interpreted as minimum intervals since uncertainty in extimatimg the slope is not allowed for.
- Preliminary study:
- Results of the preliminary study indicated that the acute median lethal oral dose to male and female rats of isopropyl acrylamide was between 400 and 1000 mg/kg bodyweight.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 383 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 322 - < 454
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 383 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 300 - < 487
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 383 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 300 - < 487
- Mortality:
- There was no deaths following a single oral dose of isopropyl acrylamide at 250 mg/kg bodyweight. However, motrality was seen among rats of both sexes at 400 mg/kg and above. Deaths occured within 22 hours to within 33 hours of dosing.
Autopsy of rats that died during the study reealed no macroscopic abnormalities. - Clinical signs:
- Pilo-erection was observed in all raths within five minutes of dosing and throughout the remainder of Day 1. This finding was accompaanied by:
abnormal body carriage, abnormal gain, lethargy, decreased respiration rate and ptosis in all rats;
pallor of the extremities in a majority of rats dosed at 400 mg/kg;
Signs observed from Day 2 onwards included:
body themors and straub tail in a majority of rats dosed at 250 and 400 mg/kg;
patting movement (following disturbance) in two males and one female rat dosed at 250 and 400 mg/kg;
restricted movemetn of the hind quarters, hypersensitivity and aggressive behaiour in a minority of rats dosed at 400 mg/kg - Body weight:
- Slightly low body weight gains were recorded for one male rat dosed at 250 mg/kg and two males and one female rat dosed at 400 mg/kg on Day 8. All other rats that survived treatment achieved anticipated bodyweight gains throughout the study.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- When a fixed slope of 8.333 was assumed the acute median lethal oral dose of isopropyl acrylamide and its 95% confidence limits were estimated to be:
Males and females combined: 383 (322 to 454) mg/kg bodyweight
Males only: 383 (300 to 487) mg/kg bodyweight
Females only: 383 (300 to 487) mg/kg bodyweight - Executive summary:
Based on the conclusion the final LD50 value is concluded as 383 mg/kg/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 383 mg/kg bw
Additional information
Justification for classification or non-classification
According to the CLP regulation substance which have an LD50 between 300 -2000 mg/kg should be assigned am acute oral hazard category 4 -Harmful if swallowed.
The LD50 value for the test substance NIPAM is 383 mg/kg therefore the acute oral classification is Acute Oral-Category 4: H302: Harmful if swallowed.
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