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EC number: 247-556-2 | CAS number: 26264-05-1
- 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
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dodecylbenzenesulphonic acid, compound with isopropylamine (1:1)
- EC Number:
- 247-556-2
- EC Name:
- Dodecylbenzenesulphonic acid, compound with isopropylamine (1:1)
- Cas Number:
- 26264-05-1
- Molecular formula:
- C18H30O3S.C3H9N
- IUPAC Name:
- sodium dodecylbenzenesulfonate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: All cells used to produce EpiDERM are purchased or derived from tissue obtained by MatTek Corporation from accredited institutions.
- Source strain:
- not specified
- Details on animal used as source of test system:
- Cells purchased or derived from suitable human tissues. The cells used were screened for potential biological contaminants.
- Justification for test system used:
- Standard as per OECD guideline
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDERM Reconstructed Human Epidermis
- Tissue batch number(s): 27636
- Production date: Not specified
- Shipping date: Not specified
- Delivery date: Not specified
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 36.2 to 37.3°C
- Temperature of post-treatment incubation (if applicable): 36.2 to 37.3°C
Test for colour interferance:
The test substance was checked for possible color interference before the study was started. Some non-colored test items may change into colored items in aqueous conditions and thus stain the skin tissues during the 1-hour exposure. To assess the color interference, 50 μl of the test item or 50 μl Milli-Q water as a negative control were added to 0.3 ml Milli-Q water. The mixture was incubated for approximately 1 hour at 37.0 ± 1.0°C in the dark. At the end of the exposure time the mixture was shaken and it was checked if a blue / purple color change was observed.
Test for reduction of MTT by the test substance:
The test substance was checked for possible direct MTT reduction before the study was started. To assess the ability of the test item to reduce MTT, 50 μl of the test item or 50 μl Milli-Q water as a negative control were added to 1 ml MTT solution (1 mg/mL) in phosphate buffered saline. The mixture was incubated for approximately 1 hour at 37.0 ± 1.0ºC. At the end of the exposure time it was checked if a blue / purple color change or a blue / purple precipitate was observed.
NUMBER OF REPLICATE TISSUES: Two tissues were used for a 3-minute exposure to the test substance and two for a 1-hour exposure. For the negative and positive controls, 2 tissues were treated with 50 μl Milli-Q water (negative control) and 2 tissues were treated with 50 μl 8N KOH (positive control) for both the 3-minute and 1-hour time point.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- 50μl of the undiluted test item was added into the 6-well plates on top of the skin tissues.
- Duration of treatment / exposure:
- 3 minutes and 1 hour of exposure
- Duration of post-treatment incubation (if applicable):
- Incubated for 3 hours with 300 µL MTT-medium.
- Number of replicates:
- Two tissues were used for a 3-minute exposure to the test substance and two for a 1-hour exposure
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute application
- Value:
- 93
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour application
- Value:
- 78
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The test substance was checked for color interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that the test item did not interfere with the MTT endpoint.
The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the substance compared to the negative control tissues was 93% and 78% respectively. Because the mean relative tissue viability for the substance was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the substance is considered to be not corrosive.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit =2.8) and the laboratory historical control data range. The mean relative tissue viability following the 1-hour exposure to the positive control was 13%. One of the triplicate OD values of one tissue treated with positive control for 1 hour was just above historical control data. Since the mean OD of the positive control was within the range and furthermore the positive control did fulfil acceptance criteria, this did not affect the study outcome.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was < 8% for the negative control. The Coefficient of Variation between tissues replicates treated with the test item was 33% after the 1-hour treatment exposure. However, both viabilities were in the same category, indicating that the test system functioned properly.
Any other information on results incl. tables
Mean Tissue Viability in the in vitro Skin Corrosion Test with the
test substance
|
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
Negative control |
100 |
100 |
Test substance |
93 |
78 |
Positive control |
7.6 |
13 |
Mean Absorption in thein vitro Skin Corrosion Test with the test
substance
|
3-minute application |
1-hour application |
||||||||
A (OD570) |
B (OD570) |
Mean (OD570) |
SD |
A (OD570) |
B (OD570) |
Mean (OD570) |
SD |
|||
Negative control |
2.060 |
1.911 |
1.985 |
± |
0.105 |
1.966 |
1.939 |
1.953 |
± |
0.019 |
Test substance |
1.943 |
1.755 |
1.849 |
± |
0.133 |
1.825 |
1.230 |
1.528 |
± |
0.421 |
Positive control |
0.167 |
0.134 |
0.150 |
± |
0.023 |
0.298 |
0.199 |
0.249 |
± |
0.070 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In this table the values are corrected for background absorption (0.0427). Isopropanol was used to measure the background absorption.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, the test substance is not corrosive in the in vitro skin corrosion test under the experimental conditions described.
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