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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 January 1990 - 02 February 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: GLP, The United Kingdom 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 Agenct, (FIFRA) Title 40 Code of Federal Regulations Part 160, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
- 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 Notification No. Yakuhatsu 313 Pharmaceutical Affairs Bureau, 31 March 1982 and subsequent amendment 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: Japan Ministry of International Trade and Industry, Directive 31 March 1984
- Qualifier:
- according to guideline
- Guideline:
- other: OECD ISBN 92-64-12367-9, Paris 1982
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-isopropylacrylamide
- EC Number:
- 218-638-5
- EC Name:
- N-isopropylacrylamide
- Cas Number:
- 2210-25-5
- Molecular formula:
- C6H11NO
- IUPAC Name:
- N-isopropylacrylamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Storage: 4 °C in the dark
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 °C in the dark
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11 to 14 weeks
- Weight at study initiation: 2.6 to 3.3 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): free access to SDS Standard Rabbit Diet
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: were acclimated (not specified how)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): approximately 19 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 0.5g amount of isopropyl acrylamide moistured with 0.5 ml distilled water
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours after application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm
- Type of wrap if used: ''Elastoplast'' elastic adhesive dressing backed with ''Sleek'' plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped to remove any residual test substance
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS
24h and 72 h
SCORING SYSTEM:
Erythema and eschar formation:
- no erythema 0
- very slight erythema 1
- well-defined erythema 2
- moderate to severe erythema 3
- severe erythema to slight eschar formation 4
Oedema formation:
- no oedema 0
- very slight oedema 1
- slight oedema 2
- moderate oedema 3
- severe oedema 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.7
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the CLP application criteria guidance document the substance is not classified for Skin Irritation.
- Executive summary:
Based on the CLP application criteria guidance document the substance is not classified for Skin Irritation.
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