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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
Eye irritation
Administrative data
- Endpoint:
- eye 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted 09. Oct. 2017
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- adopted 14. Feb. 2017
Bovine Corneal Opacity and Permeability Test Method for Identifying (i) Chemicals Inducing Serious Eye Damage and (ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage - Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals, Series on Testing and Assessment No. 160
- Version / remarks:
- 25. Oct. 2011 / “GUIDANCE DOCUMENT ON “THE BOVINE CORNEAL OPACITY AND PER-MEABILITY (BCOP) AND ISOLATED CHICKEN EYE (ICE) TEST METHODS: COL-LECTION OF TISSUES FOR HISTOLOGICAL EVALUATION AND COLLECTION OF DATA ON NON-SEVERE IRRITANTS”
- 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
Test animals / tissue source
- Species:
- other: bovine
- Strain:
- other: Bos primigenius Taurus
- Details on test animals or tissues and environmental conditions:
- Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
Test item: Replicate 1: 1.0655g, Replicate 2: 1.0282 g, Replicate 3:1.0712 g
Positive control: 750 µL
Negative control: 750 µL
- Concentration (if solution):
Test item: The test item was given on the epithelium in such a manner that the cornea was covered with test item.
Positive control: Imidazole solution: 20% C3H4N2 (CAS-No. 288-32-4), dissolved in HBSS, batch no.: 20180829.
Negative control: Hank’s Balanced Salt Solution (HBSS) 10-fold concentrated, diluted in demin. water (1:10), batch no.: 20180829 - Duration of treatment / exposure:
- 4 hours at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- 90 minutes at 32 ± 1 °C
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- -SELECTION AND PREPARATION OF CORNEAS:
Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour.
After having carefully cleaned and sterilised the cornea holders, they were kept in the incubation chamber at 32 ± 1 °C.
On the day of the assay, the MEM without phenol red was supplemented with sodium bicarbonate, L-glutamine and 1% fetal calf serum (= complete MEM) and stored in a water bath at 32 ± 1 °C.
The same was performed with the MEM with phenol red, but without addition of sodium bicarbonate.
-QUALITY CHECK OF THE ISOLATED CORNEAS:
The corneas were examined and only corneas which were free from damages were used
-NUMBER OF REPLICATES: 3
-NEGATIVE CONTROL USED: Yes (HBSS)
-POSITIVE CONTROL USED: Yes (Imidazole, 20 % solution in HBSS)
-APPLICATION DOSE AND EXPOSURE TIME:
Test item: Replicate 1: 1.0655g, Replicate 2: 1.0282 g, Replicate 3:1.0712 g
Positive control: 750 µL
Negative control: 750 µL.
EXPOSURE TIME: 4 hours at 32 ± 1 °C
-TREATMENT METHOD: Open chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period:
Rinsing the anterior chamber with cMEM with phenol red and final rinsing with cMEM without phenol red.
- POST-EXPOSURE INCUBATION:
90 minutes at 32 ± 1 °C.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 106.38
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.84 |
1.54 |
88.21% |
0.67 |
|||
3.10 |
|||
Test Item |
154.87 |
106.38 |
50.33% |
115.36 |
|||
48.92 |
|||
Positive Control 20% imidazole solution |
105.22 |
103.28 |
7.59% |
94.66 |
|||
109.97 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS (The calculated mean IVIS was 106.38.) > 55 induces serious eye damage, that should be classified as UN GHS Category I.
- Executive summary:
Thisin vitrostudy was performed to assess corneal damage potential of1,3,2-Dioxathiane, 2,2-dioxideby quantitative measurements of changes in opacity and permeability in a bovine cornea.
Two experiments were performed. The first experiment was not valid, because the mean IVIS value of the negative control was too high. Therefore the experiment was declared invalid and repeated. This experiment is not reported, but the raw data are kept in the GLP-archive of the test facility. The second performed experiment was valid and reported.
The test item1,3,2-Dioxathiane, 2,2-dioxidewas brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been determined. The test item was incubated on the cornea for 4 hoursat32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.
The test item was tested neat. Under the conditions of this test, the test item1,3,2-Dioxathiane, 2,2-dioxideinduced serious eye damage on the cornea of the bovine eye. The calculated mean IVIS was 106.38.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 55 induces serious eye damage, that should be classified as UN GHS Category I.
The negative control (HBSS) and the positive control (20% imidazole solution) have met the validity criteria.
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.
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