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EC number: 220-688-8 | CAS number: 2867-47-2
- 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
In a well-conducted study, the substance induced severe erythema, oedema and necrosis 24 h after application. For all animals, the maximum score of 4 was noted for erythema and oedema. The reactions persisted to 72 hours.
In a well conducted study, severe corneal, iris and conjuctival lesions were displayed within 2 hours of instillation. The study was terminatined after 2 h. It is reasonable to assume, that similar level of injury would be induced if full scale testing would be conducted. Therefore, the substance is judged as eye corrosive.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Non-GLP, no details on test substance incl. purity, 48-hour reading missing, short observation period).
- Principles of method if other than guideline:
- According to the method described in the Federal Hazardous Substances Labelling Act Regulations, Section 191.11, published in the Federal Register - 29 F.R. 13009, 1964.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No details.
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact (shaved) and abraded
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 4
- Details on study design:
- A 0.5 mL sample of the test material was applied to areas of intact and abraded areas of skin. These areas were then occluded with square surgical gauge patches, each measuring 1 inch x 1 inch. After 24 hrs exposure, the patches were removed and the resulting reactions evaluated. The valuation was done again at 72 hrs.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: not examined
- Remarks on result:
- other: Observation period too short for a clear conclusion on reversibility.
- Remarks:
- Only time point 24 and 72 hours were observed.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: not examined
- Remarks on result:
- other: Observation period too short for a clear conclusion on reversibility.
- Remarks:
- Only time point 24 and 72 hours were observed.
- Irritant / corrosive response data:
- Severe erythema, oedema and necrosis were exhibited 24 hrs following application. Reactions persisted to 72 hrs. For all animals and for both of
intact skin and abraded skin, maximum score of 4 was marked in the erythema and oedema rating, therefore a Primary Irritation Score of 8.0 was obtained. - Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The test material is considered to be corrosive to the skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Restrictions: Exposure period 24 hours, 48-hour reading missing, short observation period (72 hours).
- Principles of method if other than guideline:
- Draize test according to "Appraisal of the safety of chemicals in foods, drugs and cosmetics", by the staff of the Division of Pharmacology, FDA.
- GLP compliance:
- no
- Specific details on test material used for the study:
- TEST MATERIAL:
- Name of test material (as cited in study report): 2-dimethylaminoethyl methacrylate
- Physical state: colourless, clear liquid
- Purity: not specified
- Supplier: Röhm GmbH - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 2.5 kg
- Housing: single housing
- Diet: standard rabbit diet (Höing 222) ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1°C
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved/intact and shaved/abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated contact sites of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: rubberised cloth
SCORING SYSTEM: according to Draize (1959). - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- other: not examined
- Remarks on result:
- other: Observation period too short for a clear conclusion on reversibility.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 2.58
- Max. score:
- 4
- Reversibility:
- other: not examined
- Remarks on result:
- other: Observation period too short for a clear conclusion on reversibility.
- Irritation parameter:
- other: Draize index
- Score:
- 5.9
- Remarks on result:
- other: Draize index 5.9 of 8 (reevaluated according to OECD guideline 404).
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The TS is considered to be highly irritating to the rabbit skin.
Referenceopen allclose all
Individual skin responses:
Rabbit No. |
Time (hours) |
Intact Skin |
Abraded Skin |
||
Erythema |
Oedema |
Erythema |
Oedema |
||
1 |
24 |
4 |
4 |
4 |
4 |
72 |
4 |
4 |
4 |
4 |
|
2 |
24 |
4 |
4 |
4 |
4 |
72 |
4 |
4 |
4 |
4 |
|
3 |
24 |
4 |
4 |
4 |
4 |
72 |
4 |
4 |
4 |
4 |
|
4 |
24 |
4 |
4 |
4 |
4 |
72 |
4 |
4 |
4 |
4 |
|
5 |
24 |
4 |
4 |
4 |
4 |
72 |
4 |
4 |
4 |
4 |
|
6 |
24 |
4 |
4 |
4 |
4 |
72 |
4 |
4 |
4 |
4 |
|
Mean |
24 |
4 |
4 |
4 |
4 |
72 |
4 |
4 |
4 |
4 |
Re-evaluation of the skin irritation test with 2-dimethylaminoethyl methacrylate:
Remark: Consideration of shaved/intact skin readings only
Animal No. |
Erythema |
Edema |
||
24 h |
72 h |
24 h |
72 h |
|
1 |
0 |
0 |
0 |
0 |
2 |
4 |
4 |
3 |
3 |
3 |
4 |
4 |
3 |
3 |
4 |
4 |
4 |
3 |
3 |
5 |
4 |
4 |
3 |
3 |
6 |
4 |
4 |
4 |
3 |
Mean |
3.33 |
3.33 |
2.67 |
2.5 |
Total mean |
3.33 |
2.58 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
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 with acceptable restrictions (non-GLP, no details on test substance incl. purity, only 2-hour reading, short observation period).
- Principles of method if other than guideline:
- According to the method described in the Federal Hazardous Substances Labelling Act Regulations, Section 191.11, published in the Federal Register - 29 F.R. 13009, 1964.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No details.
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 2 hours
- Observation period (in vivo):
- 2 hours
- Number of animals or in vitro replicates:
- 2 females
- Details on study design:
- 0.1 mL of the test substance was instilled into one eye of each animal. The lids were gently held together for one second and the eye was then rinsed
with 20 mL Iukewarm water at 4 seconds after instillation. The eyes were examined 2 hrs after instillation. The scoring system used was that according to Draize. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 2 hours
- Score:
- 3
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 2 hours
- Score:
- 4
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 2 hours
- Score:
- 2
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 2 hours
- Score:
- 2
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 2 hours
- Score:
- 3
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 2 hours
- Score:
- 3
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 2 hours
- Score:
- 3
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 2 hours
- Score:
- 4
- Reversibility:
- other: not examined
- Remarks on result:
- other: The observation period was too short for a clear conclusion on the reversibilty of the irritation parameters (termination of study 2 hours after administration of the test substance).
- Irritant / corrosive response data:
- Despite the rinsing treatment severe corneal, iris and conjunctival lesions were displayed by both animals within 2 hrs of instillation. The test was
terminated at this point. lt is reasonable to assume that similar levels of injury would be produced if full scale testing were conducted, and that the
product would be classified as corrosive to the eye. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- It is reasonable to assume that similar levels of injury would be produced if full scale testing were conducted, and that the product would be classified as corrosive to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
There are three reports available. Among these, the study by Atochem was identified as the key study because it was conducted according to the recommendations of the Federal Hazardous Substances Labelling Act Regulations, Section 191.11, published in the Federal Register (USA)-29 FR13009, 1964 (Atochem, 1980). The test substance was administrated to the intact and abraded skin of New-Zealand albino rabbits at the dose level of 0.5 mL per animal under an occlusive patch for 24 hours. The cutaneous reactions were observed just after the removal of the patch and after 72 hours. Severe erythema, oedema and necrosis were observed after the test, and these symptoms persisted to the inspection after 72 hours of the test. The obtained primary irritation score was 8.0. Under these test conditions, the test substance was considered to be corrosive to the skin.
In a second study in rabbits according to the method of Draize the test substance was considered to be highly irritating to the skin (Roehm, 1977). The test substance furthermore tested on the skin of guinea pigs resulting in highly irritating effects (Roehm, 1977).
Eye irritation:
The only study available was considered to be reliable because it was conducted in accordance with the recommendations of the Federal Hazardous Substances Labelling Act (Atochem, 1980). Severe cornea, iris and conjunctivae lesions were displayed in both rabbits within 2 hours after the instillation of 0.l mL undiluted test substance into the eye. The test substance was considered to be corrosive to the eyes.
Justification for classification or non-classification
According to Annex VI of EC/1272/2008 (CLP-regulation), the test substance is classified as irritating to skin (Skin Irrit 2, H315) and irritating to eyes (Eye Irrit 2, H319). However, based on the results of two skin irritation studies in rabbits (Atochem, 1980; Roehm, 1977) and one eye irritation study in rabbits (Atochem, 1980), the test substance is considered to be corrosive to skin and eyes. Therefore, the following classification of the test substance is suggested (self-classification):
GHS classification according to Annex I of EC/1272/2008:
- Skin Corr 1B, H314
- Eye Dam1, H318
- Respiratory irritation: No classification required.
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