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EC number: 213-086-1 | CAS number: 923-02-4
- 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:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, pre-GLP but in compliance with OECD GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize protocol, published in J. Officiel de la Rep. Francaise, 21 Feb 1982
- GLP compliance:
- no
- Remarks:
- pre-GLP, but in compliance with OECD GLP principles
Test material
- Reference substance name:
- N-(hydroxymethyl) methacrylamide
- IUPAC Name:
- N-(hydroxymethyl) methacrylamide
- Reference substance name:
- N-(hydroxymethyl)methacrylamide
- EC Number:
- 213-086-1
- EC Name:
- N-(hydroxymethyl)methacrylamide
- Cas Number:
- 923-02-4
- Molecular formula:
- C5H9NO2
- IUPAC Name:
- N-(hydroxymethyl)-2-methylacrylamide
- Details on test material:
- Approx. 60 % aqueous solution, density = 1.10
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham Univ., School of Agriculture, Sutton Bonington, Leics., England
- Age at study initiation: approx. 12 - 16 weeks
- Weight at study initiation: mean value 22.73 - 3.04 kg
- Housing: single housing
- Diet: ad libitum, Rabbit Diet, A.W. Tindall Ltd., Holbeach, Lincolnshire, England
- Water: ad libitum, tap water
- Acclimation period: 5 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±4°C
- Humidity (%): 53 - 60 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and shaved/abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted, 0.5 ml
- Duration of treatment / exposure:
- 24 hrs, thereafter removal of the test material
- Observation period:
- 24h and 72h post application
- Number of animals:
- 6
- Details on study design:
- SCORING SYSTEM according to Draize, 1959:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.17
- Max. score:
- 4
- Remarks on result:
- other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
Any other information on results incl. tables
|
Remarks concerning the study result: The study for acute skin irritation/ corrosion was performed before OECD 404 came into force. For this reason the test values were reevaluated according to OECD criteria and test scores (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- N-methylol methacrylamide (approx. 60 % aqueous solution) was slightly irritating after 24 hours in a primary skin irritation study with rabbits (24/72-hour application, removal of the
test substance after 24 hours). The substance is very slightly irritating, but the effect is fully reversible after 72 hours. The classification according EU and GHS criteria is "not irritating". - Executive summary:
In a primary dermal irritation study, New Zealand White rabbits were dermally exposed (occluded, intact and scarified skin) to 0.5 ml N-methylol methacrylamide (approx. 60 % aqueous solution) for 24 hours. Thereafter, the test material was removed.
Animals then were observed up to 72 hours. Irritation was scored by the method of Draize et al, 1959.
The mean erythema score was determined to be 0.33 out of 4 and the mean oedema score 0.17 out of 4
(average value of the single scores animals no. 1-6, intact skin, 24h and 72h).
The slightly irritating effects occurred only after 24 hours and were fully reversible after 72 hours.
Therefore, the test substance has to be classified - according to EU-GHS classification criteria - as non irritant for skin (EU-GHS-hazard category: none).
Remarks concerning the study result: The study for acute skin irritation/ corrosion was performed before OECD 404 came into force. For this reason the test values were re-evaluated according to OECD criteria and test scores (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.
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