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Diss Factsheets
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EC number: 271-880-3 | CAS number: 68610-90-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Justification for read-across is given in Section 13 of IUCLID.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was performed according to the methods described in the following publications:
MatTek Corporation, Ashland, MA 01721, USA: EpiOcularTM human cell construct: Procedure details, Version 3.1a of February 10, 2010 and
Harbell J.W. et al. (2009): COLIPA Program on Optimization of Existing in-vitro Eye Irritation Assays for Entry into Formal Validation: Technology Transfer and Intra/Inter Laboratory Evaluation of EpiOcular Assay for Chemicals. Poster # 378, Society of Toxicology, March 2009. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Didodecyl fumarate
- EC Number:
- 219-280-2
- EC Name:
- Didodecyl fumarate
- Cas Number:
- 2402-58-6
- Molecular formula:
- C28H52O4
- IUPAC Name:
- didodecyl but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): Didodecyl fumarate
- Physical state: solid
- Analytical purity: 93.8 area-%
- Lot/batch No.: 0008043725
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- TEST EYE MODEL
- Description of the cell system used: EpiOcularTM; reconstructed three-dimensional human cornea model (OCL-200). The model represents a reconstructed three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratiozytes used to model the human corneal epithelium. Irritant materials are identified by their ability to induce cytotoxicity (= loss of viability) at the surface of the EpiOcularTM tissue. The decrease in cell viability is determined by MTT reduction assay.
- Source: MatTek Corporation, Ashland MA, USA.
ADAPTATION TO CELL CULTURE CONDITIONS: upon receipt, tissues were transferred into 6-well plates containing 1 ml assay medium per well and preincubated in a humidified incubator for 16 to 24 hours (37 ± 1 °C, CO2) before use. After the pre-incubation the tissues were pre-treated with 20 µl of PBS in order to wet the tissue surface. The tissues were incubated at standard culture conditions for 30 minutes.
INCUBATION CONDITIONS
- Temperature: 37 ± 1 °C
- CO2 gas concentration: 5 %
- Humidity: 90 - 95 %
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µl bulk volume (about 22 mg)
NEGATIVE CONTROL:
- 50 µl of sterile de-ionized water.
POSITIVE CONTROL SUBSTANCE:
- Amount applied: 50 µl. - Duration of treatment / exposure:
- 90 minutes
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- the test was performed in duplicates for each treatment and control group.
- Details on study design:
- TEST SITE
- Area of exposure: 0.6 cm².
REMOVAL OF TEST SUBSTANCE
- Washing: the test item was washed from the tissue three times with phosphate buffered saline (PBS). In order to remove residual test substance, washed tissues were immediatly immersed into 12-well plates, pre-filled with 5 mL/well prewarmed medium (post-soak immersion). After 12 minutes of post-soak immersion, each tissue was dried and transferred to fresh 6-well plates filled with pre-warmed medium.
- Time after start of exposure: 90 min.
CELL VIABILITY MEASUREMENTS: for determining alterations in cell viability, MTT reduction assays were performed 18 h after the incubation period. Therefore, tissues were incubated in 300 µl MTT solution for 3 h at 37 ± 1 °C and 5 % CO2. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissue in isopropanol. The optical density was measured at 570 nm wavelength in a plate spectrophotometer.
ACCEPTANCE CRITERIA
Negative control (NC): the absolute OD570 of the negative control tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is acceptable if the mean OD570 of the NC is ≥ 1.0. The mean OD570 of the NC should not exceed 2.5.
Positive control (PC): methyl acetate used as PC usually leads to a tissue viability of approx. 25 %. A viability of < 50 % is acceptable.
Tissue variability: two tissues were treated under the same conditions. A variability between the tissues is considered to be acceptable if the difference of the viability is ≤ 20 %.
EVALUATION CRITERIA
A chemical is considered as irritant when the tissue viability was less than or equal to 50 % after the exposure and post-treatment incubation period. At present no prediction is performed if the mean relative tissue viability with a test material is > 50 % ≤ 60 % as the cut off value is currently being evaluated to lie in this range. If the tissue viability after exposure and post-treatment incubation period is above 60 %, the test chemical may be considered as non-irritant.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: cell viability %
- Run / experiment:
- 90 min
- Value:
- 82
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean value of three replicates
Any other information on results incl. tables
Table: cell viability results
test substance |
|
tissue 1 |
tissue 2 |
mean |
SD |
NC |
mean OD570 |
1.646 |
1.393 |
1.52 |
|
viability [% of NC] |
108.3 |
91.7 |
100 |
16.6 |
|
test item |
mean OD570 |
1.133 |
1.349 |
1.241 |
|
viability [% of NC] |
74.6 |
88.7 |
82 |
14.2 |
|
PC |
mean OD570 |
0.43 |
0.344 |
0.387 |
|
viability [% of NC] |
28.3 |
22.6 |
25 |
5.7 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as an eye irritant according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- Non irritating to eye; cell viability = 82 %
- Executive summary:
The eye irritation potential of the category substance was assessed in the in-vitro study by using the EpiOcular model. The test chemical was applied topically to three tissues of a reconstructed three-dimensional human cornea model and the tissue viability was measured following exposure of 90 min and a post-treatment incubation period of 18 hours. The decrease in cell viability was determined by MTT reduction assay. The tissues, after the removal of the substance, were incubated with MTT medium and the optical density of the extracted formazan was measured at 570 nm. Negative and positive controls run in parallel; the % photometric absorption of test item and positive control was calculated by comparison with the negative control.
Irritant materials are identified by their ability to induce cytotoxicity (= loss of viability) at the surface of the EpiOcular tissue.
Cell viability of the tissues treated with the test substance was 82 % (mean value of three replicates). These values are laying above the threshold for irritation.
The category member substance is not considered to be irritating to the eye.
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