Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-080-7 | CAS number: 103-11-7
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 12 Dec 2000 - 13 Dec 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in compliance with GLP regulations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethylhexyl acrylate
- EC Number:
- 203-080-7
- EC Name:
- 2-ethylhexyl acrylate
- Cas Number:
- 103-11-7
- Molecular formula:
- C11H20O2
- IUPAC Name:
- 2-ethylhexyl acrylate
- Details on test material:
- - Test substance: 2-ethylhexyl acrylate
- Chemical name: 2-propenoic acid, 2-ethylhexyl ester
- Test substance No.: 00/0903-1
- Batch/Lot No.: Tank 102
- Analytical Purity: 99.7 area-% (GC)
(according to BASF AG, Analytical report)
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: temperature, protection from light
Constituent 1
In vitro test system
- Test system:
- human skin model
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 50 uL of the test substance to a reconstructed three dimensional human epidermis model (EpiDermTM). Duplicates of the EpiDermTM tissue were incubated with the test subtance for 3 minutes and 1 hour, followed by a colorimetric determination of the possibly induced cytotoxic effect. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt. The formazan production of the test substance treated epidermal tissues is compared to the negative control tissues, calculated as relative tissue viability.
TEST SYSTEM
- The EpiDerm System consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consits of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm2) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm QS) and shipped world-wide as kits (EpiDermTM 200), containing 24 tissues on shipping agarose.
- Tissue model: Epi-200
- Origin: MatTek Corporation, Ashland MA, USA
TEST PROCEDURE
- The test was performed on a total of 4 tissues per test material, negative control and positive control. Out of these 4 tissues 2 tissues are used for the 3 minutes application and 2 tissues for the 1 hour application.
- After 3 minutes (room temperature) or after 1 hour (incubator) tissue contact with the test material, the tissues were washed with buffer to remove residual test material. Rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours. After incubation tissues were washed with buffer and formazan was extracted with Isopropanol over night at room temperature. The optical density at a wavelength of 570 nm (OD570) of extracted formazan was determined spectrophotometrically and cell viability was calculated for each tissue as % of the mean of the negative control tissues. Skin corrosivity potential of the test material was classified according to remaining cell viability obtained after test material treatment with either of the 2 exposure times.
ASSAY ACCEPTANCE CRITERIA:
- Negative control (NC ): mean OD570 of the NC per exposure time > = 0.8
- Positive control (PC ): mean relative tissue viability of the 3 min positive control is <= 30 %
- Tissue variability: The inter tissue variability is considered to be acceptable if the difference of the OD570 values of
the two tissues is <= 0.3
- Killed controls (KC ): OD570 of the killed control tissues treated as negative control should be <= 0.35 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 3 min and 1h
- Duration of post-treatment incubation (if applicable):
- none
- Number of replicates:
- 2 per exposure time
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-min exposure
- Value:
- 99
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1-h exposure
- Value:
- 104
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not corrosive
Any other information on results incl. tables
Exposure: 3 min
Test article |
Mean OD570 |
Viability [% of NC] |
NC |
1.621 |
100 |
TS |
1.600 |
99 |
PC |
0.237 |
15 |
Exposure: 1 h
Test article |
Mean OD570 |
Viability [% of NC] |
NC |
1.593 |
100 |
TS |
1.663 |
104 |
PC |
0.182 |
11 |
NC = Negative control
TS = Test substance
PC = Positive control
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- Based on the observed results it was concluded, that the test substance does not have a corrosive potential in the EpiDerm skin corrosivity test under the test conditions chosen.
- Executive summary:
In order to support the decision if the local lesions caused after skin contact are to be classified as corrosion or as severe irritation, BASF AG carried out an alternative to the Draize skin test which was developed in order to differentiate between irritation and corrosion (EU Guideline B.40). The so called EpiDermTM Skin Corrosivity Test was performed using 2-ethylhexyl acrylate, purity 99.7%. The potential of 2-EHA to cause dermal corrosion was assessed by a single topical application of 50 µl of the test substance to a reconstructed three dimensional human epidermal model (EpiDermTM). Dublicates of the EpiDermTM tissue were incubated with 2-EHA for 3 minutes and 1 hour, followed by a colorimetric determination of the possibly induced cytotoxic effects. Viability of the test substance treated tissues determined after an exposure period of 3 minutes was 99% and for the exposure period of 1 hour 104% (2-EHA is not able to directly reduce MTT, the indicator used for detection of cytotoxicity). It is demonstrated that 2-EHA reacts like the negative control, while a caustic compound used as positive control proved that this system is able to detect caustic chemicals. Based on the observed results and applying the evaluation criteria of the test, 2-EHA does not have a corrosive potential in this test under the conditions chosen.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.