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EC number: 940-884-3 | 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
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- 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
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 June 2015 - 05 June 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- yes
- Remarks:
- The deivation was considered not to affect the purpose or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- yes
- Remarks:
- The deivation was considered not to affect the purpose or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- dicalcium bis(oxosilanebis(olate)) silanedione
- EC Number:
- 940-884-3
- Molecular formula:
- Not applicable for inorganic UVCB
- IUPAC Name:
- dicalcium bis(oxosilanebis(olate)) silanedione
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- other: Human Epidermis Model EpiDerm™
- Details on test animals or test system and environmental conditions:
- Source - EpiDerm™ Reconstructed Human Epidermis Model Kit - supplier MatTek. Upon receipt of the tissues the sealed 24-well plate was placed into a refridgerator.
Test system
- Amount / concentration applied:
- Test material used as supplied
- Duration of treatment / exposure:
- 3 minutes & 60 minute exposure periods.
- Details on study design:
- Pre-Test Procedure - Assessment of direct test item reduction of MTT
-50mg of test item wsa added to 900µL of a freshly prepared 1.0mg/mL MTT solution.
- The solution was incubated in the dark at 37°C, 5% CO2 in air for 3-hours
- 100µL of sterile distilled water was tested concurrently to act as a control
- The test item was found to have the ability to directly reduce MTT.
Main Test - Preincubabtion
- Assay medium was pre-warmed before use.
- 0.9mL of assay medium was pipetted into well of two pre-labelled 6-well plates for the 3 minutes and 60 minute exposure periods.
- The EpiDerm™ tissues were transferred into the 6-well plates containing the assay medium and pre-incubated for approximately 1 hour before dosing at 37°C 5% CO2
Application of Test Item and Rinsing of test item
- After pre-incubation of the EpiDerm™ tissues, the medium was aspirated and replaced with 0.9mL of fresh assay medium
- For the 60 minute exposure 50 μL of sterile distilled water (negative control) was added to the first two tissues. The tissues were dosed at regular intervals to allow for the time taken to rinse each tissue following exposure and to ensure that each tissue gets an equal exposure time. 25 mg of
the test item and 50 μL of 8.0 N Potassium Hydroxide (positive control) were also applied to the corresponding tissues in turn. 25 μL of sterile water was added for wetting of the test item. The plate was returned to the incubator (37 °C, 5% CO2) for the 60-Minute exposure period.
- The procedure was repeated for the 3-minute exposure period.
- Rinsing was done by filling and emptying each tissue under a constant stream of DPBS to remove any residual test item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper.
- Each tissue was transferred to the 24-well plate prepared for MTT loading. The plate was incubated (37 °C, 5% CO2)) for 3 hours.
- Once the 60-minute exposure period was complete the same rinsing and MTT loading procedure was repeated.
- AFter the 3-hour MTT incubation period, the inserts were blotted and transferred to labelled 24-well plates for MTT extraction.
- 2mL of MTT extractant (isopropanol) was used to completely immerse each insert and a sealed to prevent isopropanol evaporation and the plates were placed into a refridgerator overnight to allow extraction to proceed.
Absorbance/Optical Density Measurements
- After extraction each tissue was pierced with a pipette fittled with a 1000µL tip
- The extraction solution was mixed to form a homogenous solution
- Three 200µL aliquots of blue formazan extract was transferred to the pre-labelled plate
- 200µL L of isopropanol was added to the three well designated as blanks.
- Absorbency at 562nm (OD562) was measured using the Anthos 2001 microplate reader
Interpretation of Results
The corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after the 3 and 60-Minute exposure periods, compared to the mean of the negative control tissues (n=2) treated with sterile distilled water. The relative mean viabilities were calculated in the following way:
Relative mean viability (%) = (mean OD562 of test item / mean OD562 of negative control) x 1000
Classification of the corrosivity potential is based on relative viabilities for both exposure times accoding to the attached table.
Quality Criteria : The results of the assay are considered acceptable if the following critera are acheived
Negative Control: The assay establishes the acceptance criterion for an acceptable test if the mean optical density for the negative control treated tissues is ≥ 0.8.
Positive Control: The assay establishes the acceptance criterion for an acceptable test if the relative mean tissue viability for the positive control treated tissues was ≤ 30% relative to the negative control treated tissues following the 3-Minute exposure period
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute exposure
- Value:
- 83.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure
- Value:
- 95.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The relative mean viability of the test item treated tissues was 60 minute exposure 83.9% and 3 minute exposure 95.8%
Any other information on results incl. tables
Direct MTT Reduction
An assessment found the test item was able to directly reduce MTT. Therefore, an additional procedure using freeze-killed tissues was performed during the determination of skin irritation potential. However, the results obtained showed no degree of interference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results of the freeze-killed tissues for quantitative correction of results or for reporting purposes.
Test Item, Positive Control Item and Negative Control Item
Mean OD562 values and viabilities for the negative control, positive control and test item are given in the attached table.
The relative mean viability of the test item treated tissues was as follows:
60 minute exposure : 83.9%
3 minute exposure : 95.8%
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 7.4% relative to the negative control treated tissues following the 3-Minute exposure period. The positive control acceptance criterion was therefore satisfied. The mean OD562 for the negative control treated tissues was 2.127 for the 3-Minute exposure period and 2.304 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The corrosivity potential of the test item was assessed in accordance with OECD Guideline 431. The test item was considered to be non-corrosive to the skin.
- Executive summary:
Summary
The study was performed to evaluate the corrositivity of the test item using the EpiDermTMSkin Model after treatment periods of 3 & 60 minutes
Results
Duplicate tissues treated with the test item for exposure periods of 3 and 60 minutes produced relative mean viabilities of 95.8 & 83.9% respectively.
Conclusion
The test item was considered to be non-corrosive to the skin
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