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EC number: 939-404-5 | CAS number: 1469983-43-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012, November
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study, well described, according to the HCE. The Human Corneal Epithelium model, is currently under a Cosmetic Europe (CosEU, x COLIPA)-ECVAM validation study (2009-2012) as test method replacement alternative for regulatory classification (irritant/non irritant for the eye)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Human Corneal Epithelium model
- Principles of method if other than guideline:
- The method allows to evaluate a toxic event and related cytotoxicity by a colorimetric assay. Solution of MTT in balanced saline is yellowish in color. Mitochondrial dehydrogenase of viable cells cleaves the tetrazolium ring yielding blue/purple MTT crystals which are insoluble in aqueous solutions. Crystals formed by viable cells are retained in the polycarbonate filter used as substrate for the 3D construct. Intense purple colour of the cultures indicates the viability of the cell, whereas colour remains white when necrosis occurs. Negative controls are of a dark blue colour and positive controls are white-yellow.
MTT crystals are extracted by isopropanol and optical density is measured at 570 nm using the TECAN INFINITE M-200 spectrophotometer. Results are expressed as percentage of cell viability compared to the negative control. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Disodium C18-C22 sulphosuccinate
- IUPAC Name:
- Disodium C18-C22 sulphosuccinate
- Test material form:
- other: liquid
- Details on test material:
- PRODUCT NAME: Sulfosuccinate of C18-22 alcohol 30% AS (RTC No.13349)
BATCH: FL21-20-RS
MANUFACTURER : TFL Ledertechnik GmbH
PHYSICAL FORM: Liquid
STORAGE: Room temperature
EXPIRATION DATE 31.03.2014
Constituent 1
Test animals / tissue source
- Species:
- other: The SkinEthic© Reconstituted Human Corneal Epithelium
- Details on test animals or tissues and environmental conditions:
- The SkinEthic© Reconstituted Human Corneal Epithelium of 0,5 cm2 is used for the evaluation. Epithelial human Immortalized cells (HICEC) are deposed on a polycarbonate filter and cultured at the air-liquid interface for 5 days in a chemically defined medium in order to form a structured epithelium.
The model has been fully characterized (Ref. Beuermann and Nguyen) and it presents the same feature and morphology of human epithelium in vivo. The sensitivity, specificity and concordance of the model versus the Draize test (OECD TG 405) has been evaluated by using the cytotoxicity parameter for discriminating irritant and non irritant reference products from the ECETOC list (Van Goethem et al. 2006).
Test system
- Amount / concentration applied:
- The test was performed on triplicate tissues.
The positive control was Ethanol (99,99%) and the negative control was saline solution (NaCl 0,9%).
30 μL of controls (liquids) were directly and uniformly applied topically.
Sulfosuccinate of C18-22 alcohol 30% AS is a liquid and it was tested at the dose defined for liquid (30 μL) according to SOP M 04.
Eye irritation potential of the test item was assessed at 1h followed by product washing according to the relevant procedure and a post incubation period of 16h. - Duration of treatment / exposure:
- The experimental design is reported in the following scheme:
1h TREATMENT + 16h RECOVERY
DAY TIME OF TREATMENT PROCEDURES and METHODS
Tuesday 20.11.2012 OVERNIGHT ARRIVAL and PLACEMENT of TISSUES
in 12-WELL PLATE in MAINTENANCE MEDIUM
Wednesday 21.11.2012 MAINTENANCE MEDIUM CHANGE
1h TOPICAL APPLICATION of TEST ITEM,
POSITIVE CONTROL (ETHANOL) and
NEGATIVE CONTROL (SALINE SOLUTION)
PRODUCT WASHING WITH SALINE SOLUTION
16h RECOVERY INCUBATION IN FRESH MEDIUM
Thursday 22.11.2012 3h MTT TEST
(10 min QUALITATIVE EVALUATION)
2h FORMAZAN EXTRACTION IN ISOPROPANOL
SPECTRO-PHOTOMETRICAL MEASUREME
Results and discussion
In vivo
Results
- Irritation parameter:
- other: viability
- Basis:
- mean
- Time point:
- other: 16h
- Score:
- ca. 50
- Max. score:
- 100
- Reversibility:
- not specified
- Irritant / corrosive response data:
- A cell viability < 50% corresponding to the cut-off value for eye irritant classification
has been quantified for positive control (0,65%). For Sulfosuccinate of C18-22 alcohol 30% AS, a residual viability lower than 50%
(49,89%) has been calculated: this value classifies the test item as potential irritant for
the eye
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- For Sulfosuccinate of C18-22 alcohol 30% AS, a residual viability lower than 50% (49,89%) has been calculated: this value classifies the test item as potential slightly irritant for the eye
- Executive summary:
Sulfosuccinate of C18-22 alcohol 30% AS has been tested for eye irritation according to the HCE. The Human Corneal Epithelium model, is currently under a Cosmetic Europe (CosEU, x COLIPA)-ECVAM validation study (2009-2012) as test method replacement alternative for regulatory classification (irritant/non irritant for the eye). A residual viability lower than 50% (49,89%) has been calculated: this value classifies the test item as potential slightly irritant for the eye
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