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EC number: 240-714-1 | CAS number: 16669-27-5
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Docosyl methacrylate
- EC Number:
- 240-714-1
- EC Name:
- Docosyl methacrylate
- Cas Number:
- 16669-27-5
- Molecular formula:
- C26H50O2
- IUPAC Name:
- docosyl methacrylate
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The EpiDerm TM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multilayered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in viva. The EpiDerm TM tissues (surface 0.6 cm2)
are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm ø) and commercially available as kits (EpiDerm TM 200), containing 24 tissues on shipping agarose.
Skin model: Epi-200
Supplier: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
On the day of arrival in the laboratory, the tissues will be transferred to sterile 6-well plates with 0.9 ml assay medium and preconditioned in the incubator at 37°C. After
1 hour, the pre-incubation medium is replaced with fresh medium and preconditioning
continues for 18 ± 3 hours.
Three tissues are treated with each test substance, the PC and the NC, respectively. Three additional tissues (KC) will be used for the test substance and the NC, respectively, if a positive reaction has been observed in the MTT reduction test. 25 μL sterile PBS are applied first. Due to the physical state of the test substance, application with a pipette or sharp spoon is not possible. Thus, a metal pin is covered with 50 μL undiluted liquid (at ca. 50°C heated) test substance. The pin is applied with direct
contact to the tissue, covering the whole tissue surface. Before application, the test
substance is cooled down to room temperature.
Control tissues are treated concurrently with 30 μL sterile PBS (NC, NC KC (if applicable)) or 5% SOS (PC) ortest substance (KC, if applicable). After application, a
nylon mesh is placed carefully onto each tissue surface of the NC and the PC and if
applicable, onto each tissue surface of the NC KC and the test substance KC.
The tissues are kept under the laminar flow hood at room temperature for 25 minutes and in the incubator for 35 minutes. The tissues are washed with sterile PBS to remove residual test material 1 hour after start of application. Rinsed tissues are blotted on sterile absorbent paper and transferred into new 6-well plates pre-filled with 0.9 ml fresh medium. When all tissues are rinsed, the surface of each tissue is dried carefully with a sterile cotton swab. Subsequently, the tissues are incubated in the incubator at 37°C for 24 ± 2 hours.
After 24 ± 2 hours, the tissues are transferred into new 6-well plates pre-filled with 0.9 ml
fresh medium and placed into the incubator for an additional 18 ± 2-hour post-incubation
period. After the post-incubation period, the assay medium is replaced with 0.3 ml MTT solution and the tissues are incubated in the incubator for 3 hours. After incubation, the tissues are washed with PBS to stop the MTT incubation. The formazan that is produced metabolically by the tissues will be extracted by incubation of the tissues in 2 ml isopropanol at room temperature on a plate shaker (ca. 120 rpm) for at least 2 hours. After shaking the isopropanol extract, 2 aliquots of each extract per tissue will be transferred to a 96-well microtiter plate. The optical density (OD570) will be determined spectrophotometrically using a filter with a wavelength of 570 nm.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 98.8
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded, that Docosyl methacrylate does not show a skin irritation potential in the EpiDerm in vitro skin irritation test under the conditions chosen.
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