Registration Dossier
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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data are given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Modified Buehler
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- an in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
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 2-methylprop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): 2-Hydroxyethylmethacrylat; HEMA
- Physical state: liquid
- Storage condition of test material: in darkness, in the refrigerator
- Other: pH 4.2
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright; sub-strain: Hoe: DHPK (SPF- LAC.) /Boe
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht
- Weight at study initiation: 226-385 g
- Housing: two animals per cage; Macrolon Plastic cages II
- Diet (e.g. ad libitum): pellets
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6-7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 deg C +/-2
- Humidity (%): 45-55%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark; Fluorescent light, 4000 deg K, 120 Lux
IN-LIFE DATES: From: 1982-05-19 To: 1982-06-18
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL
- No. of animals per dose:
- 20- test
10- control - Details on study design:
- RANGE FINDING TESTS: The highest non-irritating concentration was determined. The entire back and both sides of 4 animals were clipped one day prior to application. The following day the animals were exposed for one 6 hour period to various concentrations of the test substance. The sample was applied in four different concentrations: 100%, 75%, 50% and 25% in Aqua dest. The responses were graded at 24 and 48 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hour/exposure
- Test groups: 1; 20 animals
- Control group:1; 10 animals
- Site: left flank
- Frequency of applications: once/week
- Concentrations: 0.5 mL
B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hour/exposure
- Test groups: 1; 20 animals
- Control group: 1; 10 animals
- Site: right flank
- Concentrations: 0.5 mL
- Evaluation (hr after challenge): 24 and 48 hours
OTHER: body weights were taken at Day 0 and at the end of the entire testing period. - Challenge controls:
- Previously untreated control animals from the induction phase.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- There was no signs of erythema or edema observed during the testing period. According to the method, the test substance is considered to cause no delayed contact hypersensitivity.
- Executive summary:
The determination of the delayed contact hypersensitivity was performed in two groups of male guinea pigs; the test group and a control group following a modified Buehler method. All animals gained weight satisfactorily during the observation period. No animals showed signs of erythema or edema. The test substance is considered to cause no delayed contact hypersensitivity.
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