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EC number: 250-284-7 | CAS number: 30674-80-7
- 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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male guinea pigs were induced with the test item by a series of 3 intradermal injections. After a 2 week rest period the animals received the epicutaneous challenge exposure, and following 2 further weeks of rest the animals were rechallenged. After additional 2 weeks, the animals received a challenge exposure with the respective polymer of the test item, which was spiked with the monomer (the test ietm itself). Naive control animals were included into the test.
- GLP compliance:
- no
- Type of study:
- other: intradermal induction without adjuvant and epicutaneous challenge
- Justification for non-LLNA method:
- Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Test material
- Reference substance name:
- 2-isocyanatoethyl methacrylate
- EC Number:
- 250-284-7
- EC Name:
- 2-isocyanatoethyl methacrylate
- Cas Number:
- 30674-80-7
- Molecular formula:
- C7H9NO3
- IUPAC Name:
- 2-isocyanatoethyl methacrylate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male
- Details on test animals and environmental conditions:
- No details are given in the study report.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: dimethyl phthalate (intradermal injections) and acetone (topical applications)
- Concentration / amount:
- 1%
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- other: dimethyl phthalate (intradermal injections) and acetone (topical applications)
- Concentration / amount:
- - challenge: 0.01, 0.1, and 1% solution
- rechallenge: 0.05, 0.1, 0.5, and 1% solution
- challenge with polymer: 50% solution, spiked with 0.01, 0.1, and 1% monomer
- No. of animals per dose:
- 9 males
- Details on study design:
- RANGE FINDING TESTS: A preliminary primary irritation test was conducted by applying, and lightly rubbing in, a drop (=0.05 mL) each of a 0.25 and 2.5% (v/v) solution of the test item (monomer) in acetone on the shaved intact skin of 10 male albino guinea pigs. Skin reactions were investigated 24 and 48 h after exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 3 single intradermal injections
- Test groups: 0.1 mL of the test item (monomer) in dimethyl phthalate
- Control group: Naive control animals were included into the study.
- Site: sacrum
- Frequency of applications: one each week over a two week period
- Duration: days 0-14
- Concentrations: 1%
B. CHALLENGE EXPOSURE
- No. of exposures: 3 (challenge and rechallenge with monomer (test item), and a second rechallenge with polymer spiked with the monomer)
- Day(s) of challenge: 28 (challenge); 42 (rechallenge); 66 (second rechallenge)
- Exposure period: no data
- Test groups: 1 drop (=0.05 mL) of the test item in acetone
- Control group: naive control animals received 1 drop (=0.05 mL) of the test item in acetone
- Site: shoulder
- Concentrations: 0.01, 0.1, and 1% (challenge); 0.05, 0.1, 0.5, and 1% (rechallenge); 50% polymer spiked with 0.01, 0.1, and 1% monomer (second challenge)
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- Only naive control animals were included into the study.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.01 and 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none stated in the study report
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 8
- Total no. in group:
- 9
- Clinical observations:
- 5 animals showed moderate erythema, 3 animals showed mild erythema, and 1 animal did not show any skin reactions.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.01, 0.1, and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none stated in the study report
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.01 and 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none stated in the study report
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 7
- Total no. in group:
- 9
- Clinical observations:
- 5 animals showed moderate erythema, 2 animals showed mild erythema, and 2 animals did not show any skin reactions.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.01, 0.1, and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none stated in the study report
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05 and 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none stated in the study report
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 4
- Total no. in group:
- 9
- Clinical observations:
- 2 animals showed moderate erythema, 2 animals showed mild erythema, and 5 animals did not show any skin reactions.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Clinical observations:
- 3 animals showed moderate erythema and 6 animals showed mild erythema.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.05, 0.1, 0.5, and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none stated in the study report
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05 and 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none stated in the study report
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Clinical observations:
- 3 animals showed mild erythema and 6 animals did not show any skin reactions.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 7
- Total no. in group:
- 9
- Clinical observations:
- 1 animal showed moderate erythema and 8 animals showed mild erythema.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05, 0.1, 0.5, and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none stated in the study report
- Group:
- positive control
- Remarks on result:
- other: positive control not reported
Any other information on results incl. tables
Results of test (ctd.)
Reading |
Hours after challenge |
Group |
Dose level |
No. with + reactions |
Total no. in group |
Clinical observations |
second rechallenge |
24 |
test group |
50% polymer with 0.01% monomer (test item) |
2 |
9 |
2 animals showed mild erythema and 7 animals did not show any skin reactions. |
second rechallenge |
24 |
test group |
50% polymer with 0.1% monomer (test item) |
6 |
9 |
1 animal showed moderate erythema, 5 animals showed mild erythema, and 2 animals did not show any skin reactions. |
second rechallenge |
24 |
test group |
50% polymer with 1% monomer (test item) |
8 |
9 |
1 animal showed erythema plus oedema, 5 animals showed moderate erythema, 2 animals showed mild erythema, and 1 animal did not show any skin reactions. |
second rechallenge |
24 |
negative control |
50% polymer with 0.01% monomer (test item) |
2 |
9 |
2 animals showed mild erythema and 7 animals did not show any skin reactions. |
second rechallenge |
24 |
negative control |
50% polymer with 0. 1% monomer (test item) |
6 |
9 |
6 animals showed mild erythema and 3 animals did not show any skin reactions. |
second rechallenge |
24 |
negative control |
50% polymer with 1% monomer (test item) |
8 |
9 |
8 animals showed mild erythema and 1 animal did not show any skin reactions. |
second rechallenge |
48 |
test group |
50% polymer with 0.01% monomer (test item) |
3 |
9 |
3 animals showed mild erythema and 6 animals did not show any skin reactions. |
second rechallenge |
48 |
test group |
50% polymer with 0. 1% monomer (test item) |
6 |
9 |
1 animal showed moderate erythema, 5 animals showed mild erythema, and 3 animals did not show any skin reactions. |
second rechallenge |
48 |
test group |
50% polymer with 1% monomer (test item) |
7 |
9 |
2 animals showed moderate erythema, 5 animals showed mild erythema, and 2 animals did not show any skin reactions. |
second rechallenge |
48 |
negative control |
50% polymer with 0.01% monomer (test item) |
1 |
9 |
1 animal showed mild erythema and 8 animals did not show any skin reactions. |
second rechallenge |
48 |
negative control |
50% polymer with 0. 1% monomer (test item) |
6 |
9 |
6 animals showed mild erythema and 3 animals did not show any skin reactions. |
second rechallenge |
48 |
negative control |
50% polymer with 1% monomer (test item) |
7 |
9 |
1 animal showed moderate erythema, 6 animals showed mild erythema, and 2 animals did not show any skin reactions. |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 1A (H317) according to Regulation (EC) No 1272/2008
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