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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

Endpoint summary
Administrative data
Description of key information
N-methylol methacrylamide showed slightly skin and eye irritating properties in animal tests. The classification according EU and GHS criteria is "not irritating".
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- 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
- 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 - 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 - 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.
- 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.
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
Reference
|
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: Draize protocol, published in J. Officiel de la Rep. Francaise, 21 April 1971 and 5 June 1973
- Principles of method if other than guideline:
- Method: according to The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Draize J. H. 1959
- GLP compliance:
- no
- Remarks:
- pre-GLP, but in compliance with OECD GLP principles
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Rosemead Rabbits Ltd., Lea Valley, Essex
- Age at study initiation: approx. 12 - 16 weeks
- Weight at study initiation: 2.13 - 2.53 kg
- Housing: single housing
- Diet: ad libitum, Rabbit diet, A.W. Tindall Ltd, Holbeach, Lincolnshire
- Water: Tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 4.5 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): approx. 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each treated animal
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- single treatment, unrinsed
- Observation period (in vivo):
- up to 7 days after treatment
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Score:
- 8.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- other: maximum individual score
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- other: maximum individual score
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- 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 in an eye irritation study with rabbits. Effects observed were redness and chemosis of the conjunctiva which were fully reversible after 7 days. The classification according EU and GHS criteria is "not irritating".
- Executive summary:
In an eye irritation study according to Journal Officiel de la Republique,White rabbits were exposed to 0.1 ml N-methylol methacrylamide (approx. 60 % aqueous solution).
Animals then were observed up to 7 days. Irritation was scored by the method of Draize et al, 1959.
Redness and Chemosis of slight to moderate grade was observed. The effects decreased after 3 days and were fully reversible after 7 days.
There was no evidence for corneal opacity or iritis.
Therefore, the test substance has to be classified - according to EU-GHS classification criteria - as non irritant to eyes (EU-GHS-hazard category: none).
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
Reference
Classification of eye irritation according EU-GHS-criteria: none
Animal No. |
Corneal opacity/Hornhauttrübung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
|
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
|
|
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
|
|
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
|
|
|
|
|
|
|
|
|
none |
|
|
|
|
|
|
||||||
Animal No. |
Iritis/Regenbogenhautentzündung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
|
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
|
|
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
|
|
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
|
|
|
|
|
|
|
|
|
none |
|
|
|
|
|
|||||||
Animal No. |
Conjunctiva redness (erythem) /Bindehautrötung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
|
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||||
1, 2 |
2 1 |
1 1 |
1 0 |
1.33 0.66 |
0 0 |
- |
|
|
|
3, 4 |
2 2 |
2 2 |
1 1 |
1.66 1.66 |
0 0 |
- |
|
|
|
5, 6 |
1 1 |
1 1 |
0 1 |
0.66 1 |
0 0 |
- |
|
|
|
|
|
|
|
|
|
|
none |
|
|
Animal No. |
Conjunctiva chemosis /Bindehautödem[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1, 2 |
1 1 |
1 1 |
0 0 |
0.66 0 |
0 0 |
- |
|
3, 4 |
2 2 |
2 2 |
1 1 |
1.66 1.66 |
0 0 |
- |
|
5, 6 |
1 1 |
1 0 |
0 0 |
0.66 0.33 |
0 0 |
- |
|
|
|
|
|
|
|
|
none |
Classification Criteria for serious Eye Damage/Eye
Category 1
- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
- Mean Draize score in 2 of 3 canimals:
corneal opacity ≥3
iritis ≥ 1,5
Category 2
- Reversible adverse effects on cornea, iris, conjunctiva
- Mean Draize score in 2 of 3 animals:
corneal opacity >= 1
iritis >= 1
redness >= 2
chemosis >= 2
Subcategory 2A
- Reversible in 21 days
Subcategory 2B
- Reversible in 7 days
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN: N-methylol methacrylamide (approx. 60 % aqueous solution) was slightly irritating after 24 hours in a primary skin irritation study with rabbits.
EYE: N-methylol methacrylamide (approx. 60 % aqueous solution) was slightly irritating in an eye irritation study with rabbits. Effects observed were redness and chemosis of the conjunctiva which were fully reversible after 7 days.
The classification according EU and GHS criteria is "not irritating".
The 60 % aqueous solution is the highest concentration available in commercial products.
Justification for selection of skin irritation / corrosion endpoint:
Reliably guideline study, pre-GLP but in compliance with OECD GLP principles. The 60 % aqueous solution is the highest concentration available in commercial products.
Justification for selection of eye irritation endpoint:
Reliable study, comparable to guideline Study well documented, meets generally accepted scientific principles, acceptable for assessment. The 60 % aqueous solution is the highest concentration available in commercial products.
Effects on skin irritation/corrosion: slightly irritating
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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