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Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 272-945-9 | CAS number: 68921-53-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - non official national or international study, well documented. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
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 potential of didodecyl fumarate to cause ocular irrritation was assessed by a single topical application of the undiluted test substance to a reconstructed three dimensional human cornea model (EpiOcularTM). 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
- Strain:
- other: EpiOcularTM; reconstructed three-dimensional human cornea model (OCL-200)
- Details on test animals or tissues and environmental conditions:
- TEST SKIN MODEL
- Source: MatTek Corporation, Ashland MA, USA
TEST METHOD
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.
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, 5% CO2) before use. After the pre-incubation the tissue 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 (INCUBATOR)
- Temperature (°C): 37 ± 1
- CO2 gas concentration (%): 5
- Humidity: 90-95%
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with the water served as negative controls, positive controls were exposed to 50 µL methyl acetate
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL bulk volume (about 22 mg)
NEGATIVE CONTROL:
- 50 µL of sterile de-ionized water
POSITIVE CONTROL SUBSTANCE:
- Positive control substance: 50 µL methyl acetate - Duration of treatment / exposure:
- 90 minutes
- Observation period (in vivo):
- Not applicable. Post-treatment period: 18 hours
- Number of animals or in vitro replicates:
- Not applicable. 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 tissue 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
- Post-treatment incubation period: 18 h
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 wave length in a plate spectrophotometer.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: cell viability (%)
- Run / experiment:
- 90 min exposure
- Value:
- 96
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
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:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not irritant
DSD: not irritant
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.
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