Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
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: 202-617-2 | CAS number: 97-90-5
- 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
Based on the available data, EGDMA is not irritating to the skin and eyes. According to annex VI of the CLP regulation (1272/2008/EC, harmonized classification) EGDMA is classified as a respiratory irritant (STOT SE cat. 3). The scientific basis for that classification is unknown.
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Pre-guideline study but comparable to guideline study. Test procedure in accordance with national standard methods with acceptable restrictions. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.
- Qualifier:
- according to guideline
- Guideline:
- other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
- Principles of method if other than guideline:
- Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field "methods and
materials". - GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Glycoldimethacrylat
- Supplier: Evonik Industries AG, Darmstadt, Germany
- Purity: not metioned, but commercial grade is assumed - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: mean value 2,5 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- 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:
- other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
- Amount / concentration applied:
- undiluted 0.5 mL
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24h and 72h post application
- Number of animals:
- 6
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- evaluation of erythema and oedema
- Basis:
- mean
- Remarks:
- Classification according to Draize score (Draize JH, 1959)
- Time point:
- other: 24 and 72 hours
- Score:
- 0.42
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.42
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- after 72 hours
- Remarks on result:
- other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Remarks:
- Evaluation according to Draize JH, 1959. 48 hour time point was not determined.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Remarks:
- Evaluation according to Draize JH, 1959. 48 hour time point was not determined.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Ethylene glycol dimethacrylate was not irritating in a primary skin irritation study with in rabbits (24/72-hour occlusive application, no wash of the test substance, re-evaluated according to OECD 404).
- Executive summary:
In a primary pre-guideline dermal irritation study New Zealand White rabbits were dermally exposed (intact and scarified skin) to 0.5 mL undiluted Ethyleneglycol dimethacrylate for 72 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al, 1959.
The mean erythema score (average value of the single scores (animals 1-6; erythema; intact skin, 24h and 72h) was determined to be 0.42 out of 4 and the mean edema score 0 out of 4. Therefore Ethylene glycol dimethacrylate is
not a dermal irritant .
Therefore the test substance has not to be classified - according to GHS classification criteria and according to Draize-criteria - as non irritant for skin (GHS-hazard category: none).
Remarks concerning the study result: The study for 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.
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.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Pre-guideline study but comparable to guideline study. Test procedure in accordance with national standard methods with acceptable restrictions. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.
- Qualifier:
- according to guideline
- Guideline:
- other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
- Principles of method if other than guideline:
- Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field "methods and
materials". - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data.
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and shaved/abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
- Amount / concentration applied:
- undiluted 0.5 mL
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24h and 72h post application
- Number of animals:
- 6
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- intact skin; evaluation of erythema and oedema
- Basis:
- mean
- Remarks:
- Classification according to Draize score (Draize JH, 1959)
- Time point:
- other: 24 and 72 hours
- Score:
- 0.583
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Remarks:
- Original data, evaluation according to Draize JH, 1959, not irritant
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of 6 animals;
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Remarks:
- Evaluation according to Draize JH, 1959. 48 hour time point was not determined.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Remarks:
- Evaluation according to Draize JH, 1959. 48 hour time point was not determined.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Ethylene glycol dimethacrylate was not irritating in a primary skin irritation study with in rabbits (24/72-hour occlusive application, no wash of the test substance, re-evaluated according to OECD 404).
- Executive summary:
In a primary pre-guideline dermal irritation study rabbits were dermally exposed (intact and scarified skin) to 0.5 mL undiluted Ethyleneglycol dimethacrylate for 72 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al, 1959.
The mean erythema score (average value of the single scores (animals 1-6; erythema; intact skin, 24h and 72h) was determined to be 0.33 out of 4 and the mean edema score 0.25 out of 4. Therefore Ethylene glycol dimethacrylate
is not a dermal irritant .
Therefore the test substance has not to be classified - according to GHS classification criteria and according to Draize-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 reevaluated 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.
Referenceopen allclose all
Overall primary irritation score (PDII): 0.42 of 8 scores FDA (Draize), 1959,
re-evaluated according to OECD 404
|
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.
Overall primary irritation score (PDII): 0.583 of 8 scores FDA (Draize), 1959,
re-evaluated according to OECD 404
|
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Pre-guideline study but comparable to guideline study.
- Qualifier:
- according to guideline
- Guideline:
- other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)
- Principles of method if other than guideline:
- Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Glykoldimethacrylat
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2,4 - 2,6 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- 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:
- 72 hours, unrinsed
- Observation period (in vivo):
- 7 days after treatment
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- not rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- re-evaluated according to OECD 405.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- re-evaluated according to OECD 405.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- re-evaluated according to OECD 405.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Classification: not irritating
- Executive summary:
In a primary pre-guideline eye irritation study ( according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)) 0.1 mL undiluted Ethyleneglycol dimethacrylate was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits, (2.4 -2.6 kg body weight) for 72 hours (not rinsed). Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according OECD-GHS criteria.
In this study Ethyleneglycol dimethacrylat is not irritating to eyes.
OECD GHS Category: none
EU GHS 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
Index of primary eye irritation: 0.0 of 13 (re-evaluated according to
OECD 405)
An initial slight irritation of the conjunctiva within the first 8 hours
(irritation scores 0-1) disappeared entirely within the first 24 h; non-irritating
Classification of eye irritation studies according OECD-GHS-criteria
Substance: Ethylene glycol dimethacrylate CAS: 97 -90 -5
Internal No.: UNTER78 -007
Date/Expert: 15 -12 -2011/RG
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 |
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 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 |
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 |
Classification: Hazard Category |
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
Based on the available test data EGDMA induces slight and reversible irritation. These effects are clearly below the threshold for classification; hence, EGDMA is not regarded as irritating to skin according to the criteria of EU Directive 67/548/EEC and the CLP Regulation (1272/2008/EC) nor according to UN-GHS.
Eye
Based on the available test data EGDMA is not irritating. Hence, EGDMA is not regarded as irritating to the eye according to the criteria of EU Directive 67/548/EEC and the CLP Regulation (1272/2008/EC)
nor according to UN-GHS.
Respiratory Tract
EGDMA has a low vapour pressure and the only available data by the inhalation route is a repeated exposure screening study in rat in which aerosol production cannot be excluded. In this study, after two week exposure, slight thickening of the alveolar walls was observed which is consistent with weak irritant potential. On the other hand, acute (6hr) inhalation studies in rats with methyl and ethyl methacrylate, but not butyl methacrylate and larger esters, produces lesions in the olfactory region of the nasal cavity at 200ppm (948 mg/m³) (Jones, 2002). Based on molecular weight and vapour pressure, the saturated vapour density of EGDMA can be estimated to be approx. 10 ppm. This concentration is far lower than the irritating concentrations of the lower alkyl methacrylates. Hence, acute exposure to EGDMA is not expected to be irritating to the respiratory tract. Nevertheless, in the entry for EGDMA in Annex VI of the CLP Regulation (1272/2008/EC) in the harmonised classification for this chemical, is classified as a respiratory irritant (STOT SE, cat. 3). The exact reason for this classification – and the predecessor in Annex I of EU Directive 67/548/EEC – is unknown. For the time being, the existing classification will be carried forward.
Compliance to REACh requirements
The requirements are covered with reliable in vivo data, performed with the substance itself and before in vitro testing became current priority.
Reference:
Jones O (2002) Using physiologically based pharmacokinetic modelling to predict the pharmacokinetics and toxicity of methacrylate esters. A Thesis submitted to the U. of Manchester for the degree of Doctor of Philosophy
Justification for classification or non-classification
In non-GLP toxicity studies conducted according to standard acute methods, no signs of eye irritation and only minor signs of skin irritation were observed. These results do not lead to classification. Therefore, EGDMA is not classified according to the Annex I to the Directive 67/548/EEC and annex VI of the CLP Regulation (1272 /2008/EC) nor according to UN-GHS. According to annex VI of the CLP regulation (1272/2008/EC) EGDMA is classified as a respiratory irritant (STOT SE cat. 3). The justification for that classification is unknown.
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.