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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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.
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : 24h exposure under occlusive patch conditions, no certificate of analysis
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
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:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: young adults
- Weight at study initiation: 1500-2500 g
- 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
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and unabraded areas
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL liquid) or 0.5g (solid)
- Concentration (if solution): not applicable as the test substance is applied as supplied
VEHICLE
Not applicable - Duration of treatment / exposure:
- 24h
- Observation period:
- 48h after the patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: abdomen
- % coverage: one inch square, two application sites on the right side (abraded skin) and two application sites on the lef side (unabraded skin)
- Type of wrap if used: the test sample is applied on a coton gauze which is held in place with adhesive tape. The entire trunk of the animal is then wrapped wih a rubberized cloth
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- unabraded skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Irritation parameter:
- erythema score
- Remarks:
- unabraded skin
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Irritation parameter:
- erythema score
- Remarks:
- unabraded skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other:
- Remarks:
- No observation at 48h
- Irritation parameter:
- erythema score
- Remarks:
- unabraded skin
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Remarks:
- No observation at 48h
- Irritation parameter:
- erythema score
- Remarks:
- unabraded
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Irritation parameter:
- erythema score
- Remarks:
- unabraded
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Irritation parameter:
- edema score
- Remarks:
- unabraded skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Irritation parameter:
- edema score
- Remarks:
- unabraded skin
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Irritation parameter:
- edema score
- Remarks:
- unabraded skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Irritation parameter:
- edema score
- Remarks:
- unabraded skin
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Irritation parameter:
- edema score
- Remarks:
- unabraded skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Irritation parameter:
- edema score
- Remarks:
- unabraded skin
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No observation at 48h
- Irritant / corrosive response data:
- See details in Tables 7.3.1/1 and 7.3.1/2
- Other effects:
- no data
Any other information on results incl. tables
Table 7.3.1/1:Irritant/corrosive response data for each animal at each observation time after the topical application of the test substance on unabraded skin
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
24 h |
1/2/2 |
1/2/2 |
72 h |
0/0/0 |
0/0/0 |
Average 24h and 72h |
0.5/1.0/1.0 |
0.5/1.0/1.0 |
Reversibility |
Yes |
Yes |
Table 7.3.1/2:Irritant/corrosive response data for each animal at each observation time after the topical application of the test substance on abraded skin
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
24 h |
1/2/2 |
1/2/2 |
72 h |
1/1/1 |
0/0/0 |
Average 24h and 72h |
1/1.5/1.5 |
0.5/1.0/1.0 |
Reversibility |
No data |
Yes |
The primary dermal irritation index (PDII) was 1.92.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test item Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is not classified as skin irritant when applied topically to rabbits according to the criteria of the CLP regulation (EC) 1272/2008 and to the criteria of the Directive 67/548/EEC.
- Executive summary:
In a dermal irritation study performed similarly to the OECD guideline No. 404, 3 New Zeland Albino rabbits, were dermally exposed to 0.5 mL of undiluted Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide.
Prior to the topical application, the skin of the rabbit was prepared with a clipper to remove the hair. After clipping, the right side of the animal was prepared by making epidermal abrasions, while the left site remained intact (clipped but unabraded). The test substance was then applied on the skin (abraded or not) on two different application sites (4 application sites in total on each animal). Then the test sites were covered with an occlusive dressing for 24 hours. Those exposure conditions correspond to a worst case approach as the test guidance recommends an exposure under semi-occlusive patch and for4h.Skin irritation was assessed and scored according to the Draize scale at 24 and 72 hrs after the topical application of the test patch.
The mean individual scores calculated within 2 scoring times (24 and 72 hrs) for the unabraded skin were 0.5/1.0/1.0 for erythema and 0.5/1.0/1.0 for edema.
Under the test conditions, the test item Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is not classified as skin irritant when applied topically to rabbits according to the criteria of the CLP regulation (EC) 1272/2008 and to the criteria of the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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