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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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:
- guideline study without detailed documentation
- 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:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted July 22, 2010
- Deviations:
- no
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The model represents a reconstructed three-dimensional skin model based on normal human-derived epidermal keratinocytes which have been cultured to form a multilayered epidermis including basal, spinous and granular layers, and a multi-layered stratum corneum. Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlaying cell layers which is determined through a decrease in cell viability as determined by MTT reduction assay.
- Vehicle:
- other: minimally moistened with PBS
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM; reconstructed three-dimensional human epidermis (EPI-200).
- Source: MatTek Corporation, Ashland MA, USA.
ADAPTATION TO CELL CULTURE CONDITIONS: upon receipt, tissues were transferred into 6-well plates containing 900 µl assay medium per well and preincubated in a humidified incubator for at least 1 h (37 ± 1 °C, 5 % CO2) before use.
INCUBATION CONDITIONS
- Temperature: 37 ± 1 °C.
- CO2 gas concentration: 5 %.
- Humidity: 90 - 95 %.
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing steps: the test item was washed from the skin surface with phosphate buffered saline.
- Time after start of exposure: 60 min.
CELL VIABILITY MEASUREMENTS: for determining alterations in cell viability, MTT reduction assays were performed about 42 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.
DECISION CRITERIA: a chemical is considered as irritant when the tissue viability is less than or equal to 50 % after the exposure and post- treatment incubation period. If the tissue viability after exposure and post-treatment incubation period is above 50%, the test chemical may be considered as non-irritant.
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): 5 % SDS is used as PC and reflects the sensitivity of the tissues used in the test conditions. A viability of ≤ 20 % is acceptable.
Tissue variability: For every treatment, 3 tissues are treated in parallel. The inter-tissue variability is considered to be acceptable if the SD is ≤ 20 %. - Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 µl bulk volume (about 15 mg).
- Concentration: 50 % (v/v).
- Area of exposure: 0.6 cm²
VEHICLE
- Amount(s) applied: 25 µl.
- Concentration: 50 %. - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 ± 4 h
- Number of replicates:
- the test was performed in triplicates for each treatment and control group.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 96
- 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 |
tissue 3 |
mean |
SD |
|
NC |
mean OD570 |
2.404 |
2.415 |
2.401 |
2.407 |
|
viability [% of NC] |
99.9 |
100.3 |
99.8 |
100 |
0.29 |
|
test item |
mean OD570 |
2.281 |
2.049 |
2.589 |
2.306 |
|
viability [% of NC] |
94.8 |
85.1 |
107.6 |
96 |
11.27 |
|
PC |
mean OD570 |
0.096 |
0.09 |
0.105 |
0.097 |
|
viability [% of NC] |
4 |
3.7 |
4.4 |
4 |
0.32 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as skin irritant according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- Not irritating to the skin; cell viability = 96 %.
- Executive summary:
The irritation potential of the category member substance to the skin was assessed in-vitro according to the OECD Guideline 439. The substance was applied topically to a three-dimensional human skin model, comprising a reconstituted epidermis with a functional stratum cornneum. Irritation was identified by the ability of the substance to produce a decrease in cell viability after 1 hour of exposure and 42 hours post-treatment incubation, quantified by the formazane production. For this reason, 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.
Cell viability of the tissues treated with the test substance was 96 % (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 skin.
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