Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 271-843-1 | CAS number: 68609-93-8
- 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:
- From February 18, 2014 to February 24, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- EC Number:
- 271-843-1
- EC Name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Cas Number:
- 68609-93-8
- Molecular formula:
- A generic formula cannot be provided for this UVCB substance. The alkyl chain length of the sulfonated fatty acids range from C12-C22, however the major alkyl chain is C18.
- IUPAC Name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Test material form:
- other: powder/flakes with lumps
- Details on test material:
- - Name of test material (as cited in study report): 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Physical state: Beige-yellow powder/flakes with lumps (i.e., determined at WIL Research Europe B.V.)
- Analytical purity: 100%
- Water content: 0.5%
- pH: 6 at concentration of 1g/L
- Lot/batch No.: 7495382
- Expiration date of the lot/batch: December 31, 2015
- Storage condition of test material: At room temperature in the dark
- Stability in vehicle: Water: Yes
- Solubility in vehicle: Water: Completely miscible
Constituent 1
Test animals
- Species:
- other: human three dimensional epidermal model (i.e., EPISKIN Small Model (EPISKIN-SMTM))
Test system
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 10.0 to 11.7 mg of solid test substance was applied directly on top of the skin tissue - Duration of treatment / exposure:
- 15 minutes
- Observation period:
- After a 42 h post-incubation period, determination of the cytotoxic (i.e., irritancy) effect was performed
- Details on study design:
- - Test for reduction of MTT by the test substance:
Test substance was checked for possible direct MTT reduction before the study was started. 11.9 mg of the test substance was added to 2 mL of MTT solution (i.e., 0.3 mg/mL in PBS). The mixture was incubated for 3 h at 37°C. A negative control, sterile Milli-Q water was tested concurrently.
- Application/Treatment of the test substance:
The test was performed on a total of 3 tissues per test substance, negative and positive controls. 10.0 to 11.7 mg of solid test substance (i.e., with a small glass weight boat) was added into 12-well plates on top of the skin tissues. The skin was moistened with 5 μL Milli-Q water (Millipore Corp., Bedford, Mass., USA) to ensure close contact of the test substance to the tissue. Three tissues were treated with 25 μL PBS (i.e., negative control) and 3 tissues with 25 μL 5% sodium dodecyl sulphate (SDS) (i.e., positive control) respectively. The positive control was re-spread after 7 minutes contact time. After the exposure period of 15 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test substance. After rinsing the cell culture inserts were each dried carefully and moved to a new well on 2 mL pre-warmed maintenance medium until all tissues were dosed and rinsed. Subsequently the skin tissues were incubated for 42 h at 37°C.
- Cell viability measurement:
After incubation, cell culture inserts were dried carefully to remove excess medium and were transferred into a 12-wells plate prefilled with 2 mL MTT-medium (i.e., 0.3 mg/mL). The tissues were incubated for 3 h at 37°C. After incubation the tissues were placed on blotting paper to dry the tissues. Total biopsy was made by using a biopsy punch. Epidermis was separated from the collagen matrix and both parts were placed in prelabeled microtubes and extracted with 500 μL isopropanol (Merck, Darmstadt, Germany). Tubes were stored refrigerated and protected from light for approximately 69 h. The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with the TECAN Infinite® M200 Pro Plate Reader.
Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. Skin irritation potential of the test substance was classified according to remaining cell viability following exposure of the test substance.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: Cell viability (%)
- Run / experiment:
- 15 minutes treatment time followed by 42 h post-incubation period.
- Value:
- 95
- Negative controls validity:
- valid
- Remarks on result:
- other: Basis: mean
- Other effects / acceptance of results:
- The relative mean tissue viability obtained after 15 minutes treatment with test substance compared to the negative control tissues was 95%. Since the mean relative tissue viability for test substance was above 50%, the test substance was considered to be non-irritant.
Any other information on results incl. tables
The absorption at 570 nm measured after treatment with test substance and controls are presented below:
Table 1: Individual OD measurements at 570 nm.
Test system |
A (OD570) |
B (OD570) |
C (OD570) |
Negative control |
|
|
|
OD570 measurement 1 |
1.402 |
1.004 |
1.152 |
OD570 measurement 2 |
1.311 |
1.037 |
1.160 |
Test substance |
|
|
|
OD570 measurement 1 |
1.137 |
1.062 |
1.132 |
OD570 measurement 2 |
1.154 |
1.058 |
1.175 |
Positive control |
|
|
|
OD570 measurement 1 |
0.196 |
0.441 |
0.226 |
OD570 measurement 2 |
0.234 |
0.452 |
0.229 |
Table 2: Mean absorption values of test substance, negative and positive controls.
Test System |
A (OD570) |
B (OD570) |
C (OD570) |
Mean±SD (OD570) |
Negative control |
1.315 |
0.979 |
1.114 |
1.136±0.169 |
Test substance |
1.104 |
1.018 |
1.112 |
1.078±0.052 |
Positive control |
0.173 |
0.404 |
0.186 |
0.254±0.130 |
OD = optical density
SD = Standard deviation
Triplicate exposures are indicated by A, B and C.
In this table the values are corrected for background absorption (0.042). Isopropanol was used to measure the background absorption.
The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range.
Mean tissue viability obtained after 15 minutes treatment with test substance compared to the negative control tissues is given below:
Table 3: Mean tissue viability values of test substance, negative and positive controls.
Test System |
Mean tissue viability (percentage of control) |
Negative control |
100 |
Test substance |
95 |
Positive control |
22 |
The standard deviation value of the percentage viability of three tissues treated identically was less than 15%, indicating that the test system functioned properly.
Result of test for reduction of MTT by the test substance:
As no colour change was observed in the assay, it was concluded that test substance did not interact with MTT.
Acceptability of the assay:
The test is considered acceptable because it meets the following criteria:
a) The absolute mean OD570 (optical density at 570 nm) of the three tissues of the negative control should reasonably be within the laboratory historical control data range and the Standard Deviation value (SD) of the % viability should be ≤18.
b) The mean relative tissue viability of the positive control should be ≤ 40% relative to the negative control and the Standard Deviation value (SD) of the % viability should be ≤18.
c) The SD calculated from individual % tissue viabilities of the three identically treated replicates should be ≤18.
Data evaluation and statistical procedures
A test substance is considered irritant in the skin irritation test if:
The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test substance and 42 h of post incubation is ≤ 50% of the mean viability of the negative controls.
A test substance is considered non-irritant in the in vitro skin irritation test if:
The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test substance and 42 h of post incubation is >50% of the mean viability of the negative controls.
The preceding criteria are not absolute and other modifying factors may enter into the final evaluation decision.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Under the study conditions, the test substance was considered to be non-irritating to skin.
- Executive summary:
A study was conducted to determine the skin irritation potential of the test substance in a human three dimensional epidermal model (EPISKIN Small Model (EPISKIN-SMTM)) according to OECD Guideline 439, in compliance with GLP. Skin tissue was moistened with 5 μL of Milli-Q water and 10.0 to 11.7 mg of test substance was applied on top of the tissue for 15 minutes. After a 42 h post-incubation period, determination of the cytotoxic (irritancy) effect was performed using the MTT assay. The relative mean tissue viability, compared to the negative control, was 95%, therefore the substance was considered to be non-irritating. The positive control had a mean cell viability of 22% after 15 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. Under the study conditions, the test substance was considered to be non-irritating to skin (Verbaan, 2014).
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.