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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
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- 2-hydroxyethyl methacrylate
- EC Number:
- 212-782-2
- EC Name:
- 2-hydroxyethyl methacrylate
- Cas Number:
- 868-77-9
- Molecular formula:
- C6H10O3
- IUPAC Name:
- 2-hydroxyethyl methacrylate
- Test material form:
- liquid
Constituent 1
- 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
Test animals
- 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
Test system
- 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)
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
- Primary irritation index of the shaved skin
- Primary irritation index of the shaved/scarified skin
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 |
|
|
|
|
|
|
Applicant's summary and conclusion
- 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.
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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