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EC number: 260-612-0 | CAS number: 57195-28-5
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dipotassium dodecenylsuccinate
- EC Number:
- 260-612-0
- EC Name:
- Dipotassium dodecenylsuccinate
- Cas Number:
- 57195-28-5
- Molecular formula:
- C16H26K2O4*H2O
- IUPAC Name:
- Dipotassium dodecenylsuccinate
- Test material form:
- liquid
- Details on test material:
- 30 % aqueous solution
pure substance is solid (bulk/powder), but is only used as aqueous solution and blends it into mixture
Substance dissolves in water at 40wt%, then becomes gel and becomes solid, if mixed 61wt% with water
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkinTM –Small model (SM), reconstructed epidermis units (area: 0.38 cm2)
- Tissue batch number(s):
- Production date:
- Shipping date:
- Delivery date:
- Date of initiation of testing:
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After treatment, each treated epidermis unit was rinsed with 25ml sterile 0.01M PBS pH 7.4. After rinsing, the unit was placed on absorbent paper to remove the PBS solution from epidermal surface. Cotton-bud was used to sweep the surface carefully when necessary.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/ml
- Incubation time: 3 hours
- Wavelength: 570nm
NUMBER OF REPLICATE TISSUES: 2
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability is < 35% after 3 min exposure OR ≥ 35% after 3 min exposure AND <35% after 60 min exposure OR ≥ 35% after 60 min exposure AND <35% after 240 min exposure.
- The test substance is considered to be non-corrosive to skin if the viability ≥ 35% after 240 min exposure. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µl were dosed
- Duration of treatment / exposure:
- 240 min
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1: 3 min exposure
- Value:
- 106.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2: 60 min exposure
- Value:
- 38.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3: 240 min exposure
- Value:
- 11.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Based on the above results,
1. The OD mean value of the 2 epidermis units of the negative control substance (0.9% NaCl saline) are 1.009 at 3 min exposure, 0.920 at 60 min exposure and 0.883 at 240 min exposure, respectively; the OD mean values are≥0.6 and≤1.5 in each exposure time, i.e., meets the requirement of acceptance;
2. The mean viability of the 2 epidermis units of the positive control substance (glacial acetic acid) is 6.4% at 240 min exposure; the mean viability is≤20%, i.e., meets the requirement of acceptance;
3. In the range of 20-100% viability and for OD value≥0.3, the difference of viability between the 2 epidermis unit replicates are less than 30%, i.e., meets the requirement of acceptance;
4. The mean viability of the test item is 106.7% at 3 min exposure, 38.7% at 60 min exposure and 11.2% at 240 min exposure, respectively. Therefore, based on the prediction model for the EpiSkinTMskin corrosion test method and associated with UN GHS classification system, the test item is considered as Corrosive, a combination of optional Sub-categories 1B-and-1C.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Based on the prediction model for the EpiSkinTM skin corrosion test method and associated with CLP classification system, the test item - Dipotassium dodecenylsuccinate (aq. solution), Lot No: 170727 is considered as Corrosive, a combination of optional Sub-categories 1B-and-1C.
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