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EC number: 859-869-7 | CAS number: 201419-80-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,4,8,10-tetraoxa-3λ⁶,9λ⁶-dithiaspiro[5.5]undecane-3,3,9,9-tetrone
- EC Number:
- 859-869-7
- Cas Number:
- 201419-80-9
- Molecular formula:
- C5H8O8S2
- IUPAC Name:
- 2,4,8,10-tetraoxa-3λ⁶,9λ⁶-dithiaspiro[5.5]undecane-3,3,9,9-tetrone
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Name: 2,4,8,10-Tetraoxa-3,9-dithiaspiro[5.5]undecane, 3,3,9,9-tetraoxide
CAS No.: 201419-80-9
Lot number: AZ08AVL1
Active component: ≥99% (Assay by GC: 99.9%)
Appearance: crystalline solid, white
Expiration date: 21 September 2021
Storage conditions: room temperature, protected from humidity, in a well-closed
container
Safety precautions: routine safety precautions (lab coat, gloves, safety masks, face mask,
goggles)
In vitro test system
- Test system:
- human skin model
- Source species:
- other: EpiSkinTM Small Model (EpiSkinTMSM), EPISKIN Laboratories Lyon, France, is a threedimensional human epidermis model.
- Cell type:
- other: Adult human-derived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen.
- Cell source:
- other: Adult human-derived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen.
- Source strain:
- not specified
- Details on animal used as source of test system:
- not applicable
- Justification for test system used:
- The EPISKIN model has been validated for corrosivity testing in an international trial; it is
considered to be suitable for this study (STATEMENT ON THE SCIENTIFIC VALIDITY OF
THE EPISKINTM TEST (AN IN VITRO TEST FOR SKIN CORROSIVITY); ECVAM JRC
Environment Institute, European Commission; Ispra; 03 April 1998). - Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was applied in its original form, no formulation was required.
- Details on test system:
- A highly differentiated and stratified epidermis model is obtained after 13-day culture period
comprising the main basal, supra basal, spinous and granular layers and a functional stratum
corneum (Tinois et al., 1994). Its use for skin corrosion testing involves topical application of
test materials to the surface of the epidermis, and the subsequent assessment of their effects on
cell viability. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Test Item
An amount of 20 mg test item was applied evenly to the epidermal surface of the two test skin
units/exposure times respectively. Subsequently, 100 µL NaCl solution (9 g/L saline) was
added topically (to each unit) to ensure good contact with the epidermis. The test item was
spread gently with the pipette tip in order to cover evenly all the epidermal surface if necessary. - Duration of post-treatment incubation (if applicable):
- The plates with the test item treated epidermis units were incubated for the exposure times of 4
hours (±10 min), 1 hour (±5 min) and 3 minutes at room temperature. Negative controls were
tested with each exposure time (4 h, 1 h, 3 min). The positive control was tested only for the
4 h exposure time. Temperature measured during the exposure (using a min/max thermometer)
was in the range of 23.7-24.2 °C. - Number of replicates:
- In this assay 2 replicates of the test item (for each exposure time), 2 replicates of negative
control (for each exposure time) and 2 replicates of the positive control (for the 4 h exposure
only) were used.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 4h
- Value:
- ca. 104
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1h
- Value:
- ca. 102
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- ca. 107
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Every test item treated tissue viability was above 35 % of the mean negative control value after 4 hours, 1 hour and 3 minutes exposure. The average test item treated tissue relative viabilities
were 104 % at 4 hours, 102 % at 1 hour and 107 % at 3 minutes of exposure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in this in vitro skin corrosion test in EPISKIN model (OECD 431) with
2,4,8,10-Tetraoxa-3,9-dithiaspiro[5.5]undecane, 3,3,9,9-tetraoxide the results indicate
that the test item is not corrosive to skin after 4 hours, 1 hour and 3 minutes of exposure
time. In conclusion, the test item 2,4,8,10-Tetraoxa-3,9-dithiaspiro[5.5]undecane, 3,3,9,9-
tetraoxide can be classified as Non-corrosive.
EpiSkinTMSM test of the test item 2,4,8,10-Tetraoxa-3,9-dithiaspiro[5.5]undecane, 3,3,9,9-
tetraoxide has been performed to predict its corrosion potential by measurement of its cytotoxic
effect, as reflected in the MTT assay according to the OECD Test Guideline No. 431, 18 June
2019.
Disks of EPISKIN (two units / test item / incubation time) were treated with the test item and
incubated for 4 hours (±10 min), 1 hour (±5 min) and 3 minutes at room temperature. Exposure
of test item was terminated by rinsing with 1x PBS solution. The viability of each disk was
assessed by incubating the tissues for 3 hours (±15 min) with MTT solution at 37±1 °C in an
incubator with 5±1 % CO2 in a ≥ 95 % humidified atmosphere and protected from light. The
formazan precipitated was then extracted using acidified isopropanol and quantified
spectrophotometrically.
NaCl (9 g/L saline) and glacial acetic acid treated epidermis were used as negative and positive
controls, respectively.
For each treated tissue viability was expressed as a % relative to negative control. The test item
is considered to be non-corrosive to skin, if the mean relative viability after 4 hours of exposure
is above or equal 35 % of the negative control.
Every test item treated tissue viability was above 35 % of the mean negative control value after
4 hours, 1 hour and 3 minutes exposure. The average test item treated tissue relative viabilities
were 104 % at 4 hours, 102 % at 1 hour and 107 % at 3 minutes of exposure.
Positive and negative controls showed the expected cell viability values within acceptable
limits.
All assay acceptance criteria were met, the experiment was considered to be valid.
In conclusion, in this in vitro skin corrosion test in EPISKIN model (OECD 431) with
2,4,8,10-Tetraoxa-3,9-dithiaspiro[5.5]undecane, 3,3,9,9-tetraoxide the results indicate
that the test item is not corrosive to skin after 4 hours, 1 hour and 3 minutes of exposure
time. In conclusion, the test item 2,4,8,10-Tetraoxa-3,9-dithiaspiro[5.5]undecane, 3,3,9,9-
tetraoxide can be classified as Non-corrosive. - Executive summary:
EpiSkinTMSM test of the test item 2,4,8,10-Tetraoxa-3,9-dithiaspiro[5.5]undecane, 3,3,9,9-
tetraoxide has been performed to predict its corrosion potential by measurement of its cytotoxic
effect, as reflected in the MTT assay according to the OECD Test Guideline No. 431, 18 June
2019.
Disks of EPISKIN (two units / test item / incubation time) were treated with the test item and
incubated for 4 hours (±10 min), 1 hour (±5 min) and 3 minutes at room temperature. Exposure
of test item was terminated by rinsing with 1x PBS solution. The viability of each disk was
assessed by incubating the tissues for 3 hours (±15 min) with MTT solution at 37±1 °C in an
incubator with 5±1 % CO2in a ≥ 95 % humidified atmosphere and protected from light. The
formazan precipitated was then extracted using acidified isopropanol and quantified
spectrophotometrically.
NaCl (9 g/L saline) and glacial acetic acid treated epidermis were used as negative and positive
controls, respectively.
For each treated tissue viability was expressed as a % relative to negative control. The test item
is considered to be non-corrosive to skin, if the mean relative viability after 4 hours of exposure
is above or equal 35 % of the negative control.
Every test item treated tissue viability was above 35 % of the mean negative control value after
4 hours, 1 hour and 3 minutes exposure. The average test item treated tissue relative viabilities
were 104 % at 4 hours, 102 % at 1 hour and 107 % at 3 minutes of exposure.
Positive and negative controls showed the expected cell viability values within acceptable
limits.
All assay acceptance criteria were met, the experiment was considered to be valid.
In conclusion, in thisin vitroskin corrosion test in EPISKIN model (OECD 431) with
2,4,8,10-Tetraoxa-3,9-dithiaspiro[5.5]undecane, 3,3,9,9-tetraoxide the results indicate
that the test item is not corrosive to skin after 4 hours, 1 hour and 3 minutes of exposure
time. In conclusion, the test item 2,4,8,10-Tetraoxa-3,9-dithiaspiro[5.5]undecane, 3,3,9,9-
tetraoxide can be classified as Non-corrosive.
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