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EC number: 256-190-2 | CAS number: 45103-58-0
- 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
In an OECD 406 study, conducted under GLP, 2-(2-methoxyethoxy)ethyl methacrylate is not a Dermal Sensitizer in teh Guinea Pig.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Justification for type of information:
- Study method is in accordance with EPA OCSPP 870.2600 protocol.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23/02/2018 - 15/08/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was initiated due to the requirements in a non-EU jurisdiction.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Animals were received from Elm Hill Breeding Labs, Chelmsford, MA on 10 Jan 2018, 24 Jan 2018, 27 Feb 2018. Following an acclimation period of at least five days, seventeen healthy male and nineteen healthy female non-pregnant and nulliparous Hartley Albino guinea pigs were assigned to the study without conscious bias.
The animals were born the on 25 Dec 2017, 08 Jan 2018, 11 Feb 2018. The pretest body weight range was 298 - 711 grams for males and 292 - 592 grams for females. The animals were identified by cage notation and a uniquely numbered metal eartag and housed one per cage in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per
week. Fresh PMI Guinea Pig Chow (Diet No. 5025) and water were available ad libitum. The animal room, reserved exclusively for guinea pigs on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free. - Route:
- intradermal
- Vehicle:
- other: FCA
- Concentration / amount:
- 5%
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- other: Well-tolerated sytemically and did not cause local necrosis or ulceration
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 hours occlusion
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 24 hours occlusion, two weeks after Induction B
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- One group of 10 animals per sex served as the test article group. One group of five animals per sex
served as the control group. - Details on study design:
- There are two stages to the maximization test. The first stage is the induction and consists of intradermal injections followed in seven days by a topical application of the test article. The second stage is the challenge which consists of a topical application performed 14 days following completion of the induction phase.
- Challenge controls:
- Acetone
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Abnormal physical signs including soiling, wetness, and/or yellow staining of the anogenital area were observed.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Abnormal physical signs including soiling, wetness, and/or yellow staining of the anogenital area were observed.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Soiling, and/or yellow staining of the anogenital area and bleeding from Site C, left side were observed in the vehicle control group.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Soiling, and/or yellow staining of the anogenital area and bleeding from Site C, left side were observed in the vehicle control group.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an OECD 406 study, conducted under GLP, 2-(2-methoxyethoxy)ethyl methacrylate is not a Dermal Sensitizer in the Guinea Pig.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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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