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EC number: 500-232-7 | CAS number: 68815-56-5 1 - 2.5 moles ethoxylated
- 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
- Study period:
- 24 July - 05 October 2018
- 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)
- Version / remarks:
- adopted in 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP - Landesleitstelle Bayern, Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany
Test material
- Reference substance name:
- Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts
- EC Number:
- 500-232-7
- EC Name:
- Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts
- Cas Number:
- 68815-56-5
- Molecular formula:
- not applicable to UVCB
- IUPAC Name:
- Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: human-derived epidermal keratinocytes (NHEK), Strain 00267
- Justification for test system used:
- The EpiDerm(TM) Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and has been used for in vitro experiments for many years. It is known for its similarity to human skin.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm(TM) Skin Model
- Tissue batch number(s): 28646 and 28658
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
- Temperature of post-treatment incubation: 37 ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After 3 or 60 min of application, the first insert was removed from the 6-well plate with forceps. Using a wash bottle, the tissue was gently rinsed about 20 times with PBS (phosphate buffered saline) to remove any residual test item. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper. The insert was placed in a prepared 24-well “holding plate“ containing 300 μL pre-warmed assay medium per well. All inserts were treated in the same manner.
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: plate spectrophotometer
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiDerm(TM) tissues were assesed by an MTT cell viability test. The determined OD (540-570 mm) was 2.216 ± 0.075 for the first experiment and 1.802 ± 0.137 for the second experiment (acceptance criteria: 1.0 - 3.0)
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 µL of 1% Triton X-100. The ET-50 value was determined to be 6 h for the first and second experiment (acceptance criteria: 4.77 - 8.72h)
- Morphology: not reported
- Contamination: The cells used to produce the EpiDerm(TM) tissue were screened for the presence of viruses, bacteria, yeast and other fungi. No contamination was detected
- Reproducibility: The results of the positive and negative controls showed reproducibility over time.
Since the test substance did not directly reduce the MTT solution, an additional functional check was not performed.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2 independent experiments were performed
PREDICTION MODEL / DECISION CRITERIA
- 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
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg + 25 µL distilled water
NEGATIVE CONTROL
- Amount(s) applied: 50 µL distilled water
POSITIVE CONTROL
- Amount(s) applied: 50 µL 8 N KOH - Duration of treatment / exposure:
- 3 and 60 min
- Duration of post-treatment incubation (if applicable):
- 3 h with MTT solution
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure (1st experiment)
- Value:
- 90.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean value of two tissues
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute exposure (1st experiment)
- Value:
- 17.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean value of two tissues
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure (2nd experiment)
- Value:
- 93.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean value of two tissues
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute exposure (2nd experiment)
- Value:
- 5.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean value of two tissues
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes: The mena OD of the tissue replicates treated with the negative control was >= 0.8 and <= 2.8 for every exposure time (values between 1.680 and 1.723).
- Acceptance criteria met for positive control: yes: The mean relative tissue viability (% negative control) of the positive control was < 15% (6.3%) after 60 minute treatment.
- Acceptance criteria met for variability between replicate measurements: yes: The coefficient of variance (CV) (in the range 20 - 100%) of replicate tissues of all dose groups was <= 30% (values between 3.1% and 12.0%).
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 1B (H314) according to Regulation (EC) No 1272/2008
- Conclusions:
- In this study under the given conditions the test item showed corrosive effects. The mean relative tissue viability (% negative control) was reduced below 15% after 60 min treatment but not below 50% after 3 min treatment. The test item is therefore classified as “corrosive“ with sub-category 1B.
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