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EC number: 270-180-5 | CAS number: 68412-26-0
- 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:
- 31 May 2016 to 31 August 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:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Molybdenum, bis(dibutylcarbamodithioato)di-μ-oxodioxodi-, sulfurized
- EC Number:
- 270-180-5
- EC Name:
- Molybdenum, bis(dibutylcarbamodithioato)di-μ-oxodioxodi-, sulfurized
- Cas Number:
- 68412-26-0
- Molecular formula:
- C18H36N2Mo2O2S4X2 Where X = O or S
- IUPAC Name:
- Molybdenum oxide sulfide dibutyldithiocarbamate complex
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Identification: Molybdenum, bis (dibutylcarbamodithioato)
- CAS Number: 68412-26-0
Constituent 1
- Specific details on test material used for the study:
- CAS RN: 68412-26-0
Purity: This substance has an Unknown or Variable composition, is a Complex reaction product, or a Biological material (UVCB).
Physical state/Appearance: Yellow powder
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstructed human epidermis tissues
- Cell source:
- other: not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Triplicate tissues were treated with approximately 10 mg (26.3 mg/cm^2) of the test item. Triplicate tissues treated with 10 µL of DPBS served as the negative controls and triplicate tissues treated with 10 µL of SDS 5% w/v served as the positive controls. The plates were kept in the biological safety cabinet at room temperature for 15 minutes.
At the end of the exposure period, each tissue was removed from the well using forceps and rinsed using DPBS with Ca++ and Mg++. The rinsed tissues were transferred to the second column of 3 wells containing 2 mL of maintenance medium in each well and were incubated at 37 ºC, 5% CO2 in air for 42 hours.
MTT Loading/Formazan Extraction (Day 3)
Following the 42 hour post-exposure incubation period each 12-well plate was placed onto a plate shaker for 15 minutes to homogenize the released mediators in the maintenance medium. Maintenance medium from beneath each tissue was transferred to pre labeled micro tubes and stored in a freezer at 14 to 30 ºC for possible inflammatory mediator IL-1α determination.
MTT solution, freshly prepared in assay medium, was pipetted into the third column of 3 wells of the 12-well plates. The tissues were transferred to the MTT filled wells, incubated for 3 hours at 37 °C, 5% CO2 in air, and then placed onto absorbent paper to dry. A total biopsy of the epidermis was made, the epidermis was carefully separated from the collagen matrix, and both parts (epidermis and collagen matrix) placed into labeled micro tubes containing acidified isopropanol, ensuring that both the epidermis and collagen matrix were fully immersed. Each tube was plugged to prevent evaporation, mixed thoroughly on a vortex mixer, and then were refrigerated at 1 to 10 °C until Day 6 of the experiment, allowing the extraction of formazan crystals.
Absorbance/Optical Density Measurements (Day 6)
At the end of the formazan extraction period each tube was mixed thoroughly on a vortex mixer to produce a homogenous colored solution.
For each tissue, duplicate samples were transferred to the appropriate wells of a pre labeled 96 well plate. Acidified isopropanol alone was added to the two wells designated as ‘blanks’. The optical density was measured (quantitative viability analysis) at 562 nm (without a reference filter) using the Anthos 2001 microplate reader. - Control samples:
- other: Negative Control: Dulbecco’s Phosphate Buffered Saline (DPBS) with Ca++ and Mg++ and Positive Control: Sodium Dodecyl Sulphate (SDS)
- Amount/concentration applied:
- Approximately 10 mg (26.3 mg/cm^2)
- Duration of treatment / exposure:
- Triplicate tissues were treated with the test item for an exposure period of 15 minutes.
- Duration of post-treatment incubation (if applicable):
- At the end of the exposure period each tissue was rinsed before incubating for 42 hours.
- Number of replicates:
- Three.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 minute exposure period and 42 Hours post exposure incubation period.
- Value:
- 109.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Direct MTT Reduction
The MTT solution containing the test item did not turn blue or purple, which indicated that the test item did not directly reduce MTT.
Assessment of Color Interference with the MTT Endpoint
The solution containing the test item was a yellow color. This color was attributed to the intrinsic color of the test item itself. It was therefore unnecessary to run color correction tissues.
Test Item, Positive Control Item and Negative Control Item
The relative mean viability of the test item treated tissues was 109.6% after a 15-minute exposure period and 42-hour post exposure incubation period.
It was considered unnecessary to perform IL-1aanalysis as the results of the MTT test were unequivocal.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 7.2% relative to the negative control treated tissues and the standard deviation value of the viability was 1.7%. The positive control acceptance criteria were therefore satisfied.
The mean OD562 for the negative control treated tissues was 0.667 and the standard deviation value of the viability was 13.1%. The negative control acceptance criteria were therefore satisfied.
The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 4.7%. The test item acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified for Irritation (category 3 cannot be determined)
- Conclusions:
- The test item was classified as non-irritant. The following classification criteria apply: EU CLP Not classified for Irritation and UN GHS Not classified for Irritation (category 3 cannot be determined).
- Executive summary:
The purpose of this test was to evaluate the skin irritation potential of the test item using the EPISKIN^TMreconstructed human epidermis model after a treatment period of 15 minutes followed by a post exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstructed human epidermal cultures following topical exposure to the test item by means of the colorimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3 [4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test item treated tissues relative to the negative controls.
Triplicate tissues were treated with the test item for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre labeled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT-loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre labeled 96 well plate. The optical density was measured at 562 nm.
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The relative mean viability of the test item treated tissues was 109.6% after the 15 minute exposure period and 42 Hours post exposure incubation period. The quality criteria required for acceptance of results in the test were satisfied. The test item was classified as non-irritant. The following classification criteria apply: EU CLP Not classified for Irritation and UN GHS Not classified for Irritation (category 3 cannot be determined).
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