Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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 is of moderate acute toxicity by the oral route LD50 (rat): 959 mg/kg.Based on the test results N-methylol methacrylamide is allocated to EU GHS and UN GHS acute oral category 4.
Due to the low dermal absorption rate, acute dermal toxicity is not expected.
Exposure via inhalation is negligible due to the very low vapour pressure and the handling of the substance as aqueous solution only.
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:
- 1985-11-04 - 1985-12-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study OECD 401, GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted May 12, 1981
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Füllinsdorf, Switzerland
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: males: 199 - 286 g; females: 172 - 227 g
- Fasting period before study: yes, 12 - 18 hours
- Housing: Groups of five in Makrolon type-3 cages, standard softwood bedding ("Lignocel", Schill AG, Muttenz, Switzerland)
- Diet (e.g. ad libitum): Ad libitum, Pelleted standard Kliba 343, Batch 33/85 rat maintenance diet (Klingentalmühle AG, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): Ad libitum, Community tap water from Itingen, Switzerland
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 ml at 5000 mg/kg; 0therwise 10ml
- Doses:
- 200, 600, 1000 and 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Four time during test day 1 and daily during days 2 - 15
- Weighing: days 1 (pre-administration), 8 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy - Statistics:
- LOGIT-Model, (COX, analysis of Binary Data, London 1977)
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 959 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 631 - 1 556
- Remarks on result:
- other: 60 % aqueous solution
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 153 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 574 - 3 613
- Remarks on result:
- other: 60 % aqueous solution
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 853 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 377 - 1 929
- Remarks on result:
- other: 60 % aqueous solution
- Mortality:
- At 200 mg/kg: no mortalities
At 600 mg/kg: 1 male after 24 hrs, 1 female after 3 days
At 1000 mg/kg: 2 males after 24 hrs, 1 female after 3 hrs, 1 female after 5 hrs, 2 females after 24 hrs
At 5000 mg/kg: 1 male after 5hrs, 4 males after 24 hrs, 3 females after 3 hrs, 2 females after 5 hrs - Clinical signs:
- At 200 mg/kg: no signs or symtoms
At 600 mg/kg: sedation, dyspnea, ataxia (females), curved body position (females), ruffled fur (females), spasms (females)
At 1000 mg/kg: sedation, dyspnea, ataxia, curved body position, diarrhea (females), ruffled fur
At 5000 mg/kg: sedation, dyspnea, lacrimation, ataxia, curved body position, spasms, ruffled fur - Body weight:
- MALES
Dose (mg/kg) Day 1 Day 8 Day 15
200 272±12 308±13 321±15
600 249±3.5 287 312
1000 237±3.9 264 306
5000 213±13 DEAD ---
FEMALES
Dose (mg/kg) Day 1 Day 8 Day 15
200 200±4.3 215±5.1 222±5.4
600 212±14 233 242
1000 202±5.1 230 240
5000 185±9.1 DEAD --- - Gross pathology:
- At 200 mg/kg: killed - no pathologic changes
At 600 mg/kg: dead - stomach: filled, severe (1 animal) ;intestines :filled with orange to red contents (2 animals); urinary bladder :filled with dark-red contents (1 animal);
killed - no pathologic changes (8 animals)
At 1000 mg/kg: dead - stomach/intestines: filled with test article (6 animals)
killed - lung: mottled (3 animals); no pathologic changes (1 animal)
At 5000 mg/kg: dead - lung: mottled (1 animal); dark-red discolored (1 animal) ;intestines: reddend (3 animals), slightly reddend (6 animals); no pathologic changes: 1 animal - Other findings:
- no
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the test result: LD50(rat, acute oral): 959 mg/kg the test substance N-methylol methacrylamide (60% in aqueous solution) has to be
classified as acute oral toxic category 4 (EU GHS and UN GHS criteria). - Executive summary:
In an acute oral toxicity study according to OECD 401 conducted with GLP, groups of fasted male and female Wistar rats were given a single oral dose of N-methylol methacrylamide (60 % aqueous solution) at a dose levels of 200, 600, 1000 and 5000 mg/kg for both sexes.
The LD50 for males was 1153 mg/kg and for females 853 mg/kg.
Oral LD50Combined = 959 mg/kg bw
Based on the results N-methylol methacrylamide is allocated to EU GHS and UN GHS acute oral category 4.
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 959 mg/kg bw
- Quality of whole database:
- Key study valid without restriction, supporting studies show results in good accordance.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
N-methylol methacrylamide is of moderate acute toxicity by the oral route LD50 (rat): 959 mg/kg. Based on the test results N-methylol methacrylamide is allocated to EU GHS and UN GHS acute oral category 4.
Due to the low dermal absorption rate, acute dermal toxicity is not expected.
Exposure via inhalation is negligible due to the very low vapour pressure and the handling of the substance as aqueous solution only.
Justification for selection of acute toxicity – oral endpoint
The study with highest validity was determined as key study.
Justification for selection of acute toxicity – inhalation endpoint
Data waiving: exposure via inhalation is negligible due to the very low vapour pressure and the handling of the substance as aqueous solution only.
Justification for selection of acute toxicity – dermal endpoint
Data waiving: due to the low dermal absorption rate as demonstrated (see 7.2.3), acute dermal toxicity is not expected.
Justification for classification or non-classification
Based on the test results N-methylol methacrylamide is allocated to EU GHS and UN GHS acute oral category 4.
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.
