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EC number: 212-782-2 | CAS number: 868-77-9
- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Nanomaterial specific surface area
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
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- 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
Skin irritation: not irritating to rabbits in a study according to Appraisal of the safety of chemicals in food, drugs and cosmetics by the Staff of the Division of Parmacology, FDA, 1959 in food, drugs and cosmetics.
Eye irritation: irritating to the eyes of rabbits Category 2, H319 acc. CLP Regulation 1272/2008 (Category 2B acc. UN-GHS criteria)
Respiratory irritation: not expected to cause respiratory irritation, e.g. due to low vapour pressure.
HEMA is classified acc. Annex VI of Regulation EU 1272/2008 into Skin irrit 2, H315 and Eye irrit 2, H319
The key study for skin irrition does not confirm the classification as skin irritant acc. EU regulation. Eye irritation is confirmed by the study of Sterner (1978). :
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959)
- Principles of method if other than guideline:
- Method: Appraisal of the safety of chemicals in foods, drugs and cosmetics by the Staff of the Division of Pharmacology, FDA, Hautgiftigkeit nach Draize (1959)
- GLP compliance:
- no
- Specific details on test material used for the study:
- Supplier: Röhm GmbH, Darmstadt, Germany
Purity: not specified in the report.
Company data in the years of the report: 0,071 bis 0,91 % methacrylic acid - 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: 2.5 kg (average)
- Housing: individual cages
- Diet: rabbit standard diet (Höing 222)
- Water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -1 (max. limitation)
- Humidity (%): 50-60
- Photoperiod ( hrs light): 12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, shaved and scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: as a contol 2 areas of the treated animals were also shaved ans scrarified but remained untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume): 0.5 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: rubberized cloth
CONTROL.
- as a contol 2 areas of the treated animals were also shaved and scrarified but remained untreated
REMOVAL OF TEST SUBSTANCE
- Washing : no wahing was done
SCORING SYSTEM:
1. Erythema and scars formation
no erythema 0
very slight erythema 1
clear erythema 2
moderate to severe erythema 3
severe erythema (scarlet red) 4
and slightly scars formation
2. Edema formation
no edema 1
very slight edema 2
moderate edema (thickness ca. 1mm) 3
severe edema (thickness more than 4
1mm, large than the edge of the
contact) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24+72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: before end of test, animal died, not treatment related
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24+72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24+72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24+72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24+72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24+72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24+72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24+72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24+72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24+72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24+72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritant / corrosive response data:
- 2/6 animals showed mean response scores for erythema of 0.5 and 1, respectively after 24 and 72 hrs or 24 hrs, respectively. Mean erythema scores in 4/6 animals were 0.
No edema scores were detected in 6/6 animals. - Primary irritation index of the shaved skin
- Primary irritation index of the shaved/scarified skin
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification: not irritating
- Executive summary:
2 -Hydroxyethyl methacrylate was tested in a primary skin irritation test to rabbits according to "Appraisal of the safety of chemicals in food, drugs and cosmetics by the Staff of the Division of Parmacology, FDA, 1959 in food, drugs and cosmetics". 6 animals were treated with the undiluted test substance for 24 h, occlusive. After 24 hours, 2 animals showed slight erythema at the shaved intact skin (one of them died during the test not treatment related). Within 72 hours erythema were fully reversible. None of the 6 animals showed edema during the test.
Therefore in this study hydroxyethyl methacrylate is not irritating to skin according to EU regulation 1271/08 and UN-GHS requirements.
Reference
Original data of the test report:
Animal Nr. |
|
| Scores (24 h) | Scores (72 h) |
1 | shaved | Erythema and scras formation | 1 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 2 | 1 |
|
| Edema formation | 1 | 0 |
2 | shaved | Erythema and scras formation | 1 | * |
|
| Edema formation | 0 | * |
| shaved/scarified | Erythema and scras formation | 0 | * |
|
| Edema formation | 0 | * |
3 | shaved | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 1 | 0 |
|
| Edema formation | 1 | 0 |
4 | shaved | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 0 | 1 |
|
| Edema formation | 0 | 0 |
5 | shaved | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
6 | shaved | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
*= animal died prio to the end of the test, death not attributed to the treatment with the substance
Animal No. | Primary irritation index |
1 | 0.25 |
2 | 0.25* |
3 | 0.00 |
4 | 0.00 |
5 | 0.00 |
6 | 0.08 |
|
|
X1 | 0.08 |
Animal No. | Primary irritation index |
1 | 1.00 |
2 | 0.00* |
3 | 0.50 |
4 | 0.25 |
5 | 0.00 |
6 | 0.00 |
|
|
X2 | 0.29 |
Total index: X1 + X2= 0.37
* = fragmentary value
Reevaluation according to OECD 404
| Erythema |
| Edema |
|
| 24h | 72h | 24h | 72h |
Animal 1 | 1 | 0 | 0 | 0 |
Animal 2 | 1 | * | 0 | * |
Animal 3 | 0 | 0 | 0 | 0 |
Animal 4 | 0 | 0 | 0 | 0 |
Animal 5 | 0 | 0 | 0 | 0 |
Animal 6 | 0 | 0 | 0 | 0 |
Mean | 0,33333333 | 0 | 0 | 0 |
|
|
|
|
|
Total mean | 0,16666667 |
| 0 |
|
| Erythema |
| Edema |
|
|
|
|
|
|
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:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of Chemicals in foods, drugs and cosmetics by staff of the Division of Pharmacology, FDA acc. to Draize
- Principles of method if other than guideline:
- Appraisal of the safety of Chemicals in foods, drugs and cosmetics by staff of the Division of Pharmacology, FDA acc. to Draize (1959)
- GLP compliance:
- no
- Specific details on test material used for the study:
- Supplier: Röhm GmbH, Darmstadt, Germany
Purity: not specified in the report.
Company data in the years iof the report: 0,071 bis 0,91 % methacrylic acid - 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 to 2.6 kg
- Housing: individual cages
- Diet : standard diet (Höing 222)
- Water ad libitum:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C
- Humidity (%): 50-60
- Photoperiod hrs light): 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right ear of the test animals remained untreated as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume): 0.1 ml
- Concentration: undiluted - Observation period (in vivo):
- 24, 48, 72 h, 4, 5, 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing:
SCORING SYSTEM:
Scoring system for the evaluation of ear lesions Scores
1. Cornea
A. Opacity - Grade of opacity (the most opac area will be used for evaluation)
No opacity 0
Motteled or diffuse opacity
(details if iris good visible) 1
Slightly differentiated opac areas,
details of iris slightly ambiguous 2
Opac areas, no details of iris are visible,
size of pupil hardly visible 3
Opacity, iris unvisible 4
B. Size of involved total area
¼ or less but not zero 1
More than ¼, but less than ½ 2
Larger than ½ but less than ¾ 3
Larger than ¾ up to total area 4
A x B x 5 total maximum number = 80
2. Iris
A. Evaluation
Normal 0
Increasing wrinkle formation (washy trabecules )
Blood overfilling, swelling, vascular dilatation at
the edge of cornea (when one or more symptoms
occur) iris shows still light reaction (delayed
reaction is deemed to be positive) 1
No reaction against light, bleeding, changes in
iris structure (one or more symptoms) 2
A x 5 total maximum number =10
3. Conjunctiva
A. Redness
Vascular normal 0
Vascular definitely more than normal injected 1
More diffuse crimson colour, single vascular
difficult to identify 2
Diffuse flesh colour 3
B. Chemosis
No swelling 0
More than normal swelling (including nictitating membrane) 1
Definite swelling with lifting the lids 2
Swelling with semi-closed lids 3
Swelling that lids are more than semi-closed or totally
closed 4
C. Secretion
No secretion 0
Every increased secretion (not included the physiological
secretion at the inner canthus) 1
Secretion with moistening the lids and the
neighboring hairs 2
Secretion with wettening the lids and the neighboring
hairs largely beyond the eye 3
Total number (A+B+C) x 2 total maximum number = 20
The total number for the eye is the summation of the scores for cornea, iris and conjunctiva - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 2, '3, #4, #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: #2, #3, #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3, #4, #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- HEMA produced in 6/6 animals a positive response of corneal opacity >= 1 calculated as the means scores following grading at 24, 48 and 72 hours which were fully reversible within 7 days in all animals. Mean scores of iritis, conjunctival redness and conjunctival edema were below the CLP classification criteria and were also fully reversible within 7 days in all animals.
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Classification acc. CLP citeria: : irritating to eyes, Category 2, H319
Classification acc. GHS citeria: : mildly irritating to eyes, Category 2B - Executive summary:
2 -Hydroxyethyl methacrylate was tested in an eye irritation test to rabbits according to the Appraisal of the safety of Chemicals in foods, drugs and cosmetics by staff of the Division of Pharmacology, FDA acc. to Draize (1959). 6 New Zealand White rabbits received 0.1 ml of the undiluted substance into the right eye. The eyes remaind unwashed. The eye reactions were observed after 24, 48, 72 hrs and 4, 5 and 7 days. The study was reevaluated according to UN-GHS criteria. 6/6 animals had opacity scores >= 1 which were reversible within 7 days. Based on this HEMA is classified acc. CLP regulation into Category 2 (H319) and acc. UN-GHS into Category 2B.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
- HEMA has a relatively low vapour pressure;
- HEMA is only a weakly potent irritant, reaching just criteria of eye irritation Cat 2B under UN-GHS, but no classifiable effects on skin irritation;
- No local effects have been observed in a subacute inhalation study in rats exposed to maximum technically achievable concentrations of HEMA;
- The concentration of the low volatile, corrosive impurity MAA is at least five times below the respective SCL that triggers classification as respiratory irritant; and
- MAA, as primary metabolite, can theoretically cause irritative effects in the respiratory tract of rats in atmospheres saturated with HEMA. However, it is implausible that relevant local concentrations in humans can be reached, even in combination with the few MAA molecules coming from the impurity.
HEMA has been evaluated in skin irritation studies in experimental animals.
The skin irritation potential of HEMA has been evaluated in a test in rabbits according to "Appraisal of the safety of chemicals in food, drugs and cosmetics by the Staff of the Division of Parmacology, FDA, 1959 in food, drugs and cosmetics" (Sterner, Stiglic, 1977). This study was assigned a Klimisch rating of 2, reliable with restriction. Undiluted HEMA was applied with occlusion to the scarified and non-scarified skin of six rabbits for 24 hr. 2/6 animals had erythema scores of 1 after 24 hrs (one animal died not treatment related within 24 hrs.). After 72 hours none of the remaining five animals showed erythema. 0/6 animals showed edema after 24 and 72 hrs. HEMA was found to be not irritating to the rabbit skin acc. CLP and GHS classification criteria. Other available studies were reviewed and judged to be not reliable or not assignable.
HEMA has been evaluated in eye irritation studies in experimental animals.
The key study (Sterner, 1977) was assigned a Klimisch rating of 2, reliable with restriction. The test was performend in rabbits according to the Appraisal of the safety of Chemicals in foods, drugs and cosmetics by staff of the Division of Pharmacology, FDA acc. to Draize (1959). The study was reevaluated according to UN-GHS criteria. 6/6 animals had opacity scores >= 1 which were reversible within 7 days. HEMA is classified acc. CLP regulation into Category 2 (H319) and acc. UN-GHS into Category 2B.
In absence of directly applicable studies, HEMA has been evaluated for its respiratory irritation potential in a weight-of-evidence assessment.
In conclusion, there is no relevant evidence that HEMA can cause specific effects on the human respiratory tract after a single exposure based on following considerations (full assessment attached):
Justification for classification or non-classification
HEMA is classified acc. Annex VI, EU regulation 1272/2008 into Category Skin irrit 2, H315 and Eye irrit 2, H319.
Experimental studies do not confirm the classification of HEMA as skin irritant: Therefore under UN-GHS criteria HEMA is not classified for skin irritation, for eye irritation HEMA ist classified with Category 2B, H320.
Based on considerations within a comprehensive weight-of-evidence assessment, there is no basis for classification of HEMA as respiratory irritant under EU CLP or UN-GHS.
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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