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EC number: 214-022-5 | CAS number: 1073-05-8
- 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:
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 28. July 2015
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- adopted 06. Jul. 2012
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3,2-dioxathiane 2,2-dioxide
- EC Number:
- 214-022-5
- EC Name:
- 1,3,2-dioxathiane 2,2-dioxide
- Cas Number:
- 1073-05-8
- Molecular formula:
- C3H6O4S
- IUPAC Name:
- 1,3,2λ⁶-dioxathiane-2,2-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: 1,3,2-dioxathiane 2,2-dioxide
- IUPAC name: 1,3,2-Dioxathiane 2,2-dioxide
- Molecular formula: C3H6O4S
- Molecular weight: 138.14 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Cell source:
- other: EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.
- Details on animal used as source of test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissues are cultured on specially prepared cell culture inserts. - Justification for test system used:
- The test consists of a topical exposure of the neat test item to a human reconstructed epi-dermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide, present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percentage reduction of cell viability in comparison of untreated negative controls is used to predict the skin irritation potential.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1 °C
- Temperature of post-treatment incubation (if applicable): 37 ± 1 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 1 (rinsing thoroughly with DPBS)
- Observable damage in the tissue due to washing: Blotted with sterile cellulose tissue
DYE BINDING METHOD
- Dye used in the dye-binding assay: 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide (=MTT)
- Spectrophotometer: Plate spectrophotometer
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3 (Pre - Tests, Pre-Incubation of Tissues and Treatment) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The tissues were wetted with 25 µL DPBS buffer and spreading it to match the tissue size. The following amounts were applied to the tissues:
1 replicate: 26.4 mg
2 replicate: 26.7 mg
3 replicate: 26.7 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration: DPBS buffer
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration: 5% SDS solution - Duration of treatment / exposure:
- 44 hours and 10 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2
- Duration of post-treatment incubation (if applicable):
- 43 hours and 35 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 65.3
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item 1,3,2-Dioxathiane, 2,2-dioxide (EC:214-022-5) is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
- Executive summary:
One valid experiment was performed.
Three tissues of the human skin model EpiDermTMwere treated withthe test itemfor 60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by the supplier).
DPBS-buffer was used as negative control and 5% SDS solution was used as positive control.
After treatment with the negative control, the mean absorbance value was within the required acceptability criterion of 0.8 <= mean OD <= 2.8, OD was 1.6.
The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 3.7% (required:<=20%).
The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: <= 18%).
After the treatment with the test item, the mean value of relative tissue viability was reduced to 65.3%. This value is above the threshold for skin irritation potential (50%). Test items that induce values above the threshold of 50% are considered non-irritant to skin.
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