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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is a screening test but followed international guidance requirements with acceptable restrictions. The stuy method was similar to the OECD 401 Guideline.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- : no certificate of analysis, no necropsy on dead animals, no weighing of dead animals
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid
- IUPAC Name:
- Reaction mass of N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid
- Test material form:
- other: Amber liquid
- Details on test material:
- - Name of test material (as cited in study report): DV-2422N
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: young adult
- Weight at study initiation: male: 216g; female: 206g
- Fasting period before study: overnight prior to dosing
- Housing: individually housed in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
no data
IN-LIFE DATES: From: To: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
not applicable as the substance is administered as supplied
MAXIMUM DOSE VOLUME APPLIED: 4-5 mL - Doses:
- 5000 mg/kg bw
- 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 and weighing: observations daily, weighing prior dosing and at death or at the end of the 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: organ weights, histopatholog: not examined - Statistics:
- Calculation of te LD50 and 95% confidence limits by the method of moving averages, using the tables constructed by Weil.
Results and discussion
- Preliminary study:
- Not applicable: Limit test
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Dose of substance as registered (including residual water necessary for the stability and impurities)
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Dose of substance as registered (including residual water necessary for the stability and impurities)
- Remarks on result:
- other: 0/5 males died
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- ca. 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Dose of substance as registered (including residual water necessary for the stability and impurities)
- Remarks on result:
- other: 3/5 females died within 48h of dosing
- Mortality:
- 3 females died within 48 hours of dosing.
- Clinical signs:
- other: Animals appeared sickly following dosing.
- Gross pathology:
- Organs of the thorax and abdomen appeared normal in the survivors.
- Other findings:
- no other findings
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is not classified for acute oral toxicity as the LD50 combined male and female in rat is higher than 5000 mg/kg bw.
- Executive summary:
In an acute oral toxicity screening study, performed similarly to the OECD guideline No. 401, a group of Sprague Dawley male and female rats (5 animals/sex) was given a single oral dose of Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide (named as DV-2422N in the study report) by gavage at the dose of 5000 mg/kg bw. The test item was administered as supplied (undiluted). Clinical signs, mortality and body weight gain were checked for a period of up to 14 days.All surviving animals were sacrificed at the end of the study and necropsied for gross abnormalities.
Oral LD50 rat combined males and females > 5000 mg/kg bw
3/5 females died within 48 hours of dosing whereas no male died. Males gained weight normally after dosing (mean of 119g for all males) whereas the surviving females gained weight but in a lesser extent (58 and 40 g gained at the end of the observation period for the 2 surviving females). Organs of the thorax and abdomen appeared normal in the survivors.
Under the test conditions, Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is not classified for acute oral toxicity according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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.
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