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EC number: 606-834-7 | CAS number: 21806-61-1
- 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:
- 18/06/2019 - 06/09/2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2019
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5H-1,2λ⁶-oxathiole-2,2-dione
- EC Number:
- 606-834-7
- Cas Number:
- 21806-61-1
- Molecular formula:
- C3H4O3S
- IUPAC Name:
- 5H-1,2λ⁶-oxathiole-2,2-dione
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Shijiazhuang Suntec-chem Co.,Ltd; 190403
- Expiration date of the lot/batch: Apr 10, 2020
- Purity: 99.92%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in cool place. Keep container tightly closed in a dry and well-ventilated place. Containers which are opened must be carefully resealed.
- Stability under test conditions: During the study the test item sample was stored in in original containers in a dry place.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: reconstructed human epidermal model EpiDerm™ (EPI-200-SCT)
- Tissue batch number(s): No. 30804, kit C
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: tissues were topically exposed to the test chemicals for 3 (room temperature) and 60 minutes at culture conditions (37±1°C, 5±1 % CO2, humidified).
- Temperature of post-treatment incubation (if applicable): 37±1°C, 5±1 % CO2, humidified.
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: After exposition, tissues were thoroughly rinsed and blotted to remove the test item/controls.
- Observable damage in the tissue due to washing: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg per mL
- Incubation time: 3 hours
- Spectrophotometer: Libra S22
- Wavelength: 570 nm
CONTROL TISSUES USED IN CASE OF MTT DIRECT/COLOUR INTERFERENCE
1. Functional check for MTT interference was performed as follows: 25 mg of the test item was added to 1 mL MTT medium (red) and incubated in the incubator (37±1°C, 5±1 % CO2, humidified) for 1 hour. At the end of the exposure time, the presence and intensity of the staining (if any) were observed.
2. Functional check for colour interference was performed as follows: 25 mg of the test item was added to 0.3 mL of water for injection and incubated in the incubator (37±1°C, 5±1 % CO2, humidified) for about 1 hour. At the end of the exposure time, the presence and intensity of the staining (if any) were observed. Another 25 mg of the test item was added to 2.0 mL of isopropyl alcohol and incubated at room temperature without shaking for 2 hours and 15 minutes. At the end of the exposure time, the presence and intensity of the staining (if any) were observed.
NUMBER OF REPLICATE TISSUES: Three tissues were used per the test item (C1), three for the the positive (PC) and three for the negative (NC) controls
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- 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
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg of the test item with 25 μL of PBS
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL H2O
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL 8N KOH - Duration of treatment / exposure:
- 3 minutes / 60 minutes
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 3 per group
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- test item-3 minutes treatment
- Value:
- 106.6
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- test item-60 minutes treatment
- Value:
- 92.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control-3 min
- Value:
- 6.2
- Negative controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control-60 min
- Value:
- 6.8
- Negative controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The test item did not reduce MTT directly
- Colour interference with MTT: The colour of the test material did not interfere with the endpoint
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The assay meets the acceptance criterion - OD570 of the NC tissues was 1.776 (3 min) and 1.712 (60 min) which is ≥ 0.8 and ≤ 2.8.
- Acceptance criteria met for positive control: Viability of tissues treated with 8N KOH after 60 minutes treatment was 6.8% which is <15%.
- Coefficient of variation: CV was higher than 0.3 in one case (see Table 1) but this was an acceptable deviation.
Any other information on results incl. tables
Table 1:MTT test results
Time | Treatment | OD570 | Mean | SD | CV | % NC | |||
Tissues | |||||||||
1 | 2 | 3 | |||||||
3 min | NC | water | 1.64 | 1.847 | 1.842 | 1.776 | 0.096 | 0.054 | 100.0 |
C1 | 152/19 | 1.877 | 1.907 | 1.898 | 1.894 | 0.013 | 0.007 | 106.6 | |
PC | 8N KOH | 0.115 | 0.109 | 0.108 | 0.111 | 0.003 | 0.028 | 6.2 | |
60 min | NC | water | 1.737 | 1.715 | 1.685 | 1.712 | 0.021 | 0.012 | 100.0 |
C1 | 152/19 | 1.537 | 1.61 | 1.606 | 1.584 | 0.034 | 0.021 | 92.5 | |
PC | 8N KOH | 0.079 | 0.169 | 0.103 | 0.117 | 0.038 | 0.325 | 6.8 |
152/19 = 1,3 Propene Sultone
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classifed according to CLP
- Conclusions:
- In the in vitro skin corrosion test using the reconstructed human epidermal model EpiDermTM, the test item 1,3-Propene Sultone was non-corrosive.
- Executive summary:
In an in vitro skin corrosion in the human epidermal model EpiDerm (152-19-4AC), reconstructed human epidermis tissue was exposed to 25 mg of 1,3-Propenesultone (99.92%) for 3 and 60 minutes. H2O was used for the negative control and 8N KOH was used for the positive control. After removal of the test substance, the tissues were incubated with MTT for three hours and then extracted with isopropyl alcohol overnight at room temperature with shaking. The OD570 of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
The controls confirmed the validity of the study. The mean absolute OD570 of the three negative control tissues was ≥ 0.8 and ≤ 2.8 [1.776 (3 min) and 1.712 (60 min)]. The mean relative tissue viability (% negative control) of the positive control was < 15% [6.8% (60 min)]. Coefficient of variation (CV) was higher than 0.3 in one case but this was an acceptable deviation. The colour of the test substance did not interfere with the endpoint. The test substance is not directly MTT reducing. The average viability of tissues treated by the test item, 1,3-Propenesultone were higher than the threshold values (50 % and 15% respectively): 106.6 % ≥ 50% after 3 minutes exposure and 92.5% ≥ 15% after 60 minutes exposure. The test item should be regarded as non-corrosive.
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