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EC number: 700-978-5 | CAS number: -
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442E (In Vitro Skin Sensitisation assays addressing the key event on activation of dendritic cells on the Adverse Outcome Pathway for skin sensitisation)
- GLP compliance:
- yes
- Type of study:
- U937 cell line activation test (U-SENS™)
Test material
- Reference substance name:
- trisodium 2-(2-sulfonatoethoxy)ethane-1-sulfonate ethenesulfonate
- EC Number:
- 700-978-5
- Molecular formula:
- C2H3O3S.Na C4H8O7S2Na2
- IUPAC Name:
- trisodium 2-(2-sulfonatoethoxy)ethane-1-sulfonate ethenesulfonate
- Test material form:
- liquid
- Details on test material:
- Reaction mass of disodium 2,2 oxydiethanesulfonate and sodium ethenesulfonate
Purity/Composition correction factor: The test item is a multi-constituent dissolved in water, dry residue is 33.65% , the correction factor is 2.971.
COA Lot nr 202108300033 of the aqueous solution.
Sodium ethylene sulphonate content cas 3039-83-6 :25.24 % Dry content :33.65 % pH@ 25°C :9.88 Colour :130 Apha
Composition of the dry product.
Constituent 1: Sodium ethylene sulphonate cas nr 3039-83-6 : 75.1 % Constituent 2: Isethionate bisether, disodium salt cas nr 63440-92-6: 16.52 % Impurity 1: Isethionate sodium cas nr1562-00-1 : 4.12 % Impurity 2: Sodium ethionate, disodium salt cas nr 1562-03-4 : 0.62 % Impurity 3: Sodium sulfate cas nr 7757-82-6 : 2.76 % Impurity 4: Sodium ethandisulfonate disodium salt cas nr 5325-43-9 : 0.64 %
Constituent 1
- Specific details on test material used for the study:
- Reaction mass of disodium 2,2 oxydiethanesulfonate and sodium ethenesulfonate
Batch lot number:202108300033
Dry weight content : 33.65 %
In vitro test system
- Vehicle / solvent control:
- cell culture medium
- Negative control:
- DL-Lactic acid
- Positive control:
- other: 2,4,6 Trinitrobenzenesulfonic acid
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- EC150, CD86 [442E]
- Cell viability:
- The test item showed no cytotoxicity, the viability of the cells was higher than 70% at all test concentrations and therefore no CV70 values could be calculated and is considered to be higher than 200 µg/mL.
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: • No biologically relevant increase in expression levels of CD86 compared to the vehicle control was observed at any of the test concentrations after treatment with the test item. No EC150 could be calculated and is considered to be higher than 200 µg/mL.
- Key result
- Group:
- test chemical
- Run / experiment:
- run/experiment 1
- Parameter:
- EC150, CD86 [442E]
- Cell viability:
- The test item showed no cytotoxicity, the viability of the cells was higher than 70% at all test concentrations and therefore no CV70 values could be calculated and is considered to be higher than 200 µg/mL.
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No EC150 could be calculated and is considered to be higher than 200 µg/mL.
- Outcome of the prediction model:
- negative [in vitro/in chemico]
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, Reaction mass of disodium 2,2’-oxydiethanesulfonate and sodium ethenesulfonate is classified as negative (no biologically relevant increase in the expression levels of CD86 cell surface marker in the U937 cell line) under the experimental conditions described in this report.
- Executive summary:
The objective of this study is to evaluate the ability of the test item to increase the expression levels of CD86 cell surface marker in the U937 cell line activation Test (U-Sens™) assay.
The test item was evaluated for the ability to increase the expression levels of CD86 cell surface marker. An overview of the viability and CD86 cell surface marker activity is summarized in Table 1. The results of the positive, negative and vehicle controls are summarized in Table 2. An overview of EC150 and CV70 values is given in Table 3. The individual raw data are presented in Table 4 and Table 5.
Two independent experiments were performed. The cell viability before incubation with the test item was > 90% (98% and 97% in experiment 1 and 2, respectively). The cells were in these experiments incubated with the test item in a concentration range of 1.0 – 200 µg/mL. The increase of CD86 cell surface marker expression was assessed by measuring the amount fluorescent cell staining of the CD86 cell surface marker compared to the vehicle control. In addition, the viability was assessed with propidium iodide.
Experiment 1
- No precipitation was observed at the end of the incubation period in the 96-well plates.
- The test item showed no toxicity, the viability of the cells was higher than 70% at all test concentrations and therefore no CV70 values could be calculated and is considered to be higher than 200 µg/mL.
- No increase in expression levels of CD86 compared to the vehicle control was observed at any of the test concentrations after treatment with the test item. No EC150 could be calculated and is considered to be higher than 200 µg/mL.
- The test item showed no colour interference.
- The positive control (TNBS) showed a S.I. ≥ 1033% in all wells and was non-cytotoxic at all concentrations (cell viability ≥ 70%). The negative control (LA) showed a I. ≤ 88% in all wells and was non-cytotoxic at all concentrations (cell viability ≥ 70%).
Experiment 2
- No precipitation was observed at the end of the incubation period in the 96-well plates.
- The test item showed no toxicity, the viability of the cells was higher than 70% at all test concentrations and therefore no CV70 values could be calculated and is considered to be higher than 200 µg/mL.
- No biologically relevant increase in expression levels of CD86 compared to the vehicle control was observed at any of the test concentrations after treatment with the test item. No EC150 could be calculated and is considered to be higher than 200 µg/mL. At the dose level of 100µg/mL, the test item showed a CD86 induction of 153%. However, as this is only just above the threshold of 150%, and only occurred at this dose level and not at the highest dose level, this minor increase is not considered to biologically relevant.
- The test item showed no colour interference.
- The positive control (TNBS) showed a S.I. ≥ 634% in all wells and was non-cytotoxic at all concentrations (cell viability ≥ 70%). The negative control (LA) showed a I. ≤ 148% in all wells and was non-cytotoxic at all concentrations (cell viability ≥ 70%).
Both tests passed the acceptance criteria:
- At the end of the incubation treatment period, the mean viability of the triplicate untreated U937 cells was above the threshold of 90% (99% in experiment 1 and 2).
- The CD86 basal expression of untreated U937 cells is within the range of ≥ 2% and
≤ 25% in both experiments. - At least two out of three IgG1 values of untreated U937 cells fell within the range of
≥ 0.6% and < 1.5% in both experiments. - No drift in CD86 expression was observed in the untreated controls (RPMI) and negative (LA) controls.
In both experiments the positive and negative control were considered valid, and the positive control fell within the historical control data. Overall, it is concluded that the test conditions were adequate and that the test system functioned properly.
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