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EC number: 603-333-5 | CAS number: 129423-55-8
- 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
- Study period:
- 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,12-bis(2-octyldodecyl) dodecanedioate
- EC Number:
- 603-333-5
- Cas Number:
- 129423-55-8
- Molecular formula:
- C52 H102 O4
- IUPAC Name:
- 1,12-bis(2-octyldodecyl) dodecanedioate
- Details on test material:
- Test Substance Name: Dioctyldodecyl Dodecanedioate
CAS number: 129423-55-8
Batch number: P-4696
Purity: 100%
Receipt Date: 22 November 2019
Retest date: 23 September 2020
Storage on Receipt: Room Temperature (15 – 25°C)
1
In vitro test system
- Test system:
- human skin model
- Remarks:
- MatTek EpiDerm
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Cultured
- Source strain:
- other: Human (NHEK)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- "MatTek's patented EpiDerm Skin Model consists of normal, human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. Keratinocytes are cultured on specially prepared, permeable cell culture inserts ... " This system " ... closely parallels human skin. EpiDerm consists of highly organized basal, spinous, granular and comified layers analogous to those found in vivo. Epiderm cultured keratinocytes are mitotically and metabolically active."
EpiDerm, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure utilizes a water-soluble, yellow, tetrazolium salt (MTT {3- [4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide}), which is reduced by succinate dehydrogenase in the mitochondria of viable cells to a purple, insoluble formazan derivative. Substances which damage this mitochondrial enzyme inhibit the reduction of the tetrazolium salt. The amount of MTT reduced by a culture is therefore proportional to the number of viable cells.
After appropriate tissue preparation, one-hundred microliters of the liquid test article, at 100%, the reference article and the negative control (distilled water) were added to the Millicells containing the EpiDerm samples. The six (6) well plates containing the dosed EpiDerm samples were then incubated at 37°C, five (5)% carbon dioxide and >= 90% humidity. After the appropriate exposure periods, each insert was individually removed from its plate and rinsed with phosphate buffered saline (PBS) to remove any residual material. Each was then rinsed a second time. Excess liquid was shaken off and each EpiDerm sample was placed into 300 microliters of MTT solution. The EpiDerm samples were then returned to the incubator.
After the three (3) hour MTT exposure, each insert was removed and gently rinsed with PBS to remove any residual MTT solution. Excess PBS was shaken from each of the inserts, which were then blotted on the bottom using paper towels. The inserts were then each placed into one (1) well of a 24 well extraction plate. Each insert was then immersed in two (2) milliliters of extraction solution overnight. After the exposure, the liquid within each insert was decanted back into the well from which it was taken. The remaining extractant solution was then agitated and a 200 microliter aliquot of each extract was removed for evaluation. A Dynatech MR 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 570nm. With the absorbance of the negative control defined as 100%, the percent absorbencies of the test and reference articles were determined. The percentages listed in the results section directly correlate with the cell metabolism in the EpiDerm samples. - Control samples:
- yes, concurrent negative control
- other:
- Amount/concentration applied:
- 100% 100 microliters
- Duration of treatment / exposure:
- 1 hour, 4.5 hours, 20 hours
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 1
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 97
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 4.5 hours
- Value:
- 103
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 20 hours
- Value:
- 80
Any other information on results incl. tables
Test Article Percent Percent
(% & Exposure) System Viability Inhibition
Dioctyldodecyl Dodecanedioate; Lot#: P-3955
(100% - 20 hrs.) EpiDerm 80 20
(100% - 4.5 hrs.) EpiDerm 103 -3
(100% - 1 hr.) EpiDerm 97 3
Triton X-100
(1% - 20 hrs.) EpiDerm 4 96
(1% - 4.5 hr.) EpiDerm 91 9
(1% - 1 hr.) EpiDerm 93 7
For the article, semi-log scales were used to plot the percent viabilities, on the linear y axis, versus the dosing times, on the log x axis. By interpolation and where possible, the time at which the percent viability would be 50% (ET-50) was estimated.
The test article, LIQUIWAX DIADD-LQ-(MH); Lot#: P-3955, elicited an ET-50 greater than 24 hours. The Triton X-100 reference article, at 1%, elicited an ET-50 of 9.1 hours. According to MatTek Corporation, as a general guideline, the following groupings can be used in assigning expected in vivo irritancy responses based on the ET-50 results obtained using MatTek's EpiDerm:
ET-50 (hrs) | Expected In vivo Irritancy | Example |
<0.5
| Severe, probably corrosive | Conc. Nitric Acid
|
0.5-4
| Moderate | 1% Sodium Dodecyl Sulfate |
4-12
| Moderate to Mild | 1% Triton X-100 |
12-24
| Very Mild | Baby Shampoo |
24 | Non-irritating
| 10% Tween 20
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- ET-50 of test item > 24 hours therefore non-irritating
- Conclusions:
- Under the conditions of this test, the test article, Dioctyldodecyl Dodecanedioate; Lot P-3955, at 100%, has an expected in vivo dermal irritancy potential in the non-irritating range.
- Executive summary:
The test article can be considered as non-irritant to the skin.
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