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EC number: 270-307-4 | CAS number: 68424-50-0
- 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:
- Second half of June 2012 to 6 months from despatch of the audited draft
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Glp compliant with international guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
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 (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts
- EC Number:
- 270-307-4
- EC Name:
- Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts
- Cas Number:
- 68424-50-0
- Molecular formula:
- UVCB
- IUPAC Name:
- Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts
- Molecular formula: UVCB
- Physical state: liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Storage condition of test material:the storage conditions for the test item will be room temperature.
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: reconstructed human epidermis (RhE) model
- Details on test animals or test system and environmental conditions:
- The SkinEthic reconstructed human tissue model EPISKINTM consists of an airlifted, living, multi-layered tissue construct, produced in polycarbonate inserts in serum-free and chemically defined medium, featuring normal ultra-structure and functionality equivalent to human tissue in vivo.
Test system
- Type of coverage:
- other: no coverage
- Preparation of test site:
- other:
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Number of animals:
- no animals, 3 replicates
- Details on study design:
- -Media and reagents:
- SkinEthic Maintenance Medium Supplied with the EPISKINTM,to be stored at 2-8°C. To be used at room temperature (without pre-heating).
- SkinEthic Assay Medium Supplied with the EPISKINTM,to be stored at 2-8°C.
- MTT Reagent: Supplied by Sigma (cat. M2128 or equivalent).
- MTT Stock Solution: MTT Reagent 3 mg/mL in D-PBS.
- MTT Ready-to-use Solution: MTT Stock Solution diluted 1:10 (v/v) with pre-warmed SkinEthic Assay Medium (final concentration 0.3 mg/mL of MTT).
- Acidic Isopropanol: 0.04 N HCL in Isopropanol
- Water-killed epidermis: to be prepared only for MTT interacting reagents. Living epidermis is incubated with 2 mL of distilled water at 37°C, 5%CO2 and saturated humidity for 48±1 hours. The water is discarded and the samples frozen at -18 to -20°C for up to 6 months.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- > 61
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The plates will be shaked on a plate shaker for 15 ± 2 minutes at maximum speed (300 rpm/min). A volume of 1.6 mL of the medium used during the 42 h incubation period will be removed and stored at ‑20°C for possible future analysis .The tissue inserts and controls will be incubated with 2 mL / well of MTT ready to use solution with the exception of treated tissues without MTT which will be incubated with MTT ready to use solution. Plates will be incubated for 3 hours ± 5 minutes at 37°C , 5% CO2and saturated humidity. At the end of the incubation period, tissues will be placed on absorbent paper to dry. A total biopsy will be carried out by means of a specific biopsy punch supplied by skinethic to allow biopsies of the same dimensions. The epidermis will be separated from the collagen matrix and will both be placed in a microtube prefilled with 500ml of acidic isopropanol. In the case of coloured collagen, unstained and untreated collagen matrices taken from killed epidermis may substitute the coloured collagen.Tubes will be mixed by vortexing and preserved for 4 hours at room temperature (vortexing after 2 hours, for analysis on the same day) or for 1-3 days at 4°C to allow formazan extraction.
At the end of the extraction period, debris will be eliminated by short centrifugation of the tubes (e.g. at 10000 -14000 rpm for 2 minutes). Aliquots of 200ml from each sample will be read in duplicate for their absorbance at 595 nm. Optical Density (OD) values will be recorded.
VALIDITY CRITERIA:
EPISKINTM batch acceptance:
Negative controls: OD values of the negative control samples > 0.600, CV% ≤ 18.
Positive controls: mean viability expressed as percentage of the negative control ≤ 40% and CV% ≤ 18.
Test item data acceptance:
CV% ≤ 18.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the mean cell viability (61.1%) when compared to the negative control, the test item may be considered not irritant. However, since intra-replicate variability was higher than expected (CV% = 48.7% instead of < 18%), data are not considered reliable to classify the substance and a repetition of test should be carried out.
The negative and positive controls gave the expected results and the study was accepted as valid.
RTC - Executive summary:
The potential of the test item TALLOELFETTSAEURE-C15+-ALKYLESTER, SULFONIERT, NA-SALZ to be irritant to the skin was investigated through an in vitro skin irritation study using a commercial reconstructed human epidermis (RhE) model named EPISKINTM.
The test item, as well as controls, were tested for their ability to impair cell viability after an exposure period of 15 minutes followed by a 42 hour recovery period. The final endpoint of the assay is the colorimetric measurement of MTT reduction (blue formazan salt) in the test system being this reaction an index of cell viability.
Before the Main Assay, a preliminary test was carried out to evaluate the compatibility of the test item with the test system. In particular, the test item was assayed for the ability of reducing MTT and colouring water per se.
No interaction was recorded between the test item and MTT in test conditions similar to those of the Main Assay. Moreover, no colouring potential of the test item in contact with water was recorded. Thus, no additional control was added in the main phase for the evaluation of non specific coloration which may influence evaluation of results.
In the Main Assay, the test item was applied as supplied in three replicates at the treatment level of 20 μL/epidermis unit, each measuring 0.38 cm^2 (treatment level: 53 μL/cm^2).
Positive and negative controls [a 5% (w/v) sodium dodecyl sulphate solution in water and Dulbecco’s phosphate buffered saline (D-PBS)] were concurrently tested, in the same number of replicates and test conditions at the treatment level of 20 L/epidermis unit.
The negative control gave the expected baseline value and variability, in agreement with the guideline indications. According to the method, the mean value is considered the baseline value of the experiment and thus represents 100% of cell viability.
The positive control caused the expected cell death (2.9% of cell viability when compared to the negative control) and variability (CV% equal to 12.2).
Therefore, the assay was regarded as valid.
The test item induced cell death in the three replicates with a mean cell viability of 3.8% when compared to the negative control. Intra-replicate variability was higher than expected. This may be due to the nature of the substance (cream) and thus, to the fact that residues might be present on the surface even with a higher number of washings after treatment.
In these cases, according to the standard procedure defined by the Supplier, a repetition of test should be carried out.
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