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EC number: 200-901-0 | CAS number: 75-78-5
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.03.2008 to 12.08.2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Bronaugh Flow Through method
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethylsilanediol
- EC Number:
- 213-915-7
- EC Name:
- Dimethylsilanediol
- Cas Number:
- 1066-42-8
- Molecular formula:
- C2H8O2Si
- IUPAC Name:
- dimethylsilanediol
- Details on test material:
- - Name of test material (as cited in study report): Dimethylsilanediol
- Substance type: Silane
- Physical state: Colourless liquid
- Analytical purity: No data for unlabelled DMSD
- Purity test date: No data
- Lot/batch No.: 21229-79B
- Radiochemical purity (if radiolabelling):97.8 ± 0.06 %
- Specific activity (if radiolabelling): Neat 14C-DMSD: 387 mCi/g; Aqueous solution: 2.515 ± 0.07 mCi/g
- Locations of the label (if radiolabelling): C
- Expiration date of radiochemical substance (if radiolabelling): 28.02.2010
- Stability under test conditions: Stable. The concentration of 0.65% in water was considered to be the maximum achievable stable concentration
- Storage condition of test material: Refrigerated at 5±4oC
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C-dimethylsilanediol (14C-DMSD)
Test animals
- Species:
- human
- Strain:
- other: N/A
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not applicable to this test.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Duration of exposure:
- 24 hours
- Doses:
- The applied dose was determined gravimetrically by weighing the pipette pre- and post- dosing. Actual doses ranged from 9.7 to 10.4 mg of dosing solution/cell (15.2-16.2 mg/cm2 of exposed skin) and applied radioactivity ranged from from 38.7 to 41.4 µCi/cm2 of exposed skin. The applied doses delivered between 98.5 and 104.6 µg 14C-DMSD/cm2 of skin.
- No. of animals per group:
- 3 males, 2 female
- Control animals:
- no
- Details on study design:
- DOSE PREPARATION
- Method for preparation of dose suspensions: A dose solution of 14C-DMSD in water was prepared by a synthesis chemist. The radioactivity concentration and homogeneity of the dosing solution was verified on the day of dosing by liquid scintillation counting. Concentration of 14C-DMSD in dosing solution (0.65%) was calculated from the specific activity of precursor material used in synthesis of 14C-DMSD.
- Method of storage: Refrigerated at 5 ±4oC. - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Human cadaver
- Ethical approval if human skin: No data
- Type of skin: Abdominal skin
- Preparative technique: Skin samples were cleaned of underlying fat, as needed and thawed at the room temperature. Excessive hair was clipped off the skin. Each sample was sprayed with a 1% mild soap solution, and dermatomed with a mini-dermatome to separate epidermis from most of dermis. Dermatomed skin samples were placed on a gauze soaked with cell culture medium while the other skin sections were being processed. Three disc-shaped skin pieces, large enough to fit 0.64 cm2 flow-through diffusion cells, were punched out from the skin of each donor. Each skin disc was visually inspected and rinsed with ultrapure water.
- Thickness of skin (in mm): 0.3-0.45
- Membrane integrity check: yes (including test for effect of methanol on skin integrity)
- Storage conditions: Receptor fluid and extracts: refrigerated at 5±4 oC; Solubilised skin: ambient temperature
- Justification of species, anatomical site and preparative technique: None
PRINCIPLES OF ASSAY
- Diffusion cell: 0.64 cm2
- Receptor fluid: physiological buffer, Hank's Balanced Salt Solution with 0.6% HEPES, 0.005% Gentamicin and 4% Bovine Serum Albumin, pH 7.4 adjusted with 1N NaOH, and filtered through 0.22 micron filter.
- Solubility of test substance in receptor fluid: Soluble
- Flow-through system: Bronaugh flow-through apparatus was set-up with the skin area available for dosing after mounting into the diffusion cell of 0.64 cm2.
- Test temperature: No data
- Humidity: No data
- Occlusion: Semi-occlusive
- Reference substance(s): None
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Absorption in different matrices:
- Skin samples from each donor were dosed in triplicates with 14C-DMSD in aqueous solution,
before the skin integrity data were available. The average dose applied to the all skin samples
was 15.7 mg of dosing solution/cm2 of skin delivering 102.2 μg of 14C-DMSD/cm2 and 40.1
μCi/cm2 of exposed skin. The percentage of applied 14C-DMSD recovered from all
acceptable samples was 91.66%. Considerable portion of the applied 14C-DMSD
(59.51%) volatilized from the skin surface and was captured in the charcoal baskets placed above
the exposure site. In order to recover the entire radioactivity absorbed in charcoal traps it was
necessary to oxidize charcoal samples after they were extracted in acetone. After 24 hr of
exposure, 18.27% of applied dose was found on the skin surface and recovered in skin washes
and tape strips.
The total percent dose absorbed was estimated to be 13.88% of applied dose. The majority of the
absorbed 14C-DMSD penetrated the skin into receptor fluid (82.1% of absorbed dose). Therefore,
11.40% of applied dose reached the receptor fluid and 2.48% of applied dose remained in the
skin after washing and tape stripping the exposure site after 24 hr of exposure. The penetration
curve showed that there was a 3-hr lag phase with steady state flux of 14C-DMSD
established between 3 and 8 hr of exposure (1.3 μg Equivalents/cm2/hr). The mean cumulative
penetration (± standard error of the mean) over the 24 hr diffusion period was estimated to be
11.7 ± 3.2 μg equivalents of 14C-DMSD /cm2 of exposed skin with more than 80% of
14C-DMSD penetrated into receptor fluid within first 12 hr of exposure. The permeability
coefficient, Kp was estimated to be 2.0x10-4 cm/hr. - Total recovery:
- - Total recovery: 91.66%
Percutaneous absorption
- Parameter:
- percentage
- Absorption:
- 11.4 %
- Remarks on result:
- other: 24 h
- Conversion factor human vs. animal skin:
- N/A
Any other information on results incl. tables
Percentage of the volatilized dose, dose remaining on the skin and penetrating into the skin and receptor fluid after 24 hours was determined relative to applied dose (applied radioactivity).
Applicant's summary and conclusion
- Conclusions:
- In a well conducted in vitro dermal absorption study conducted to GLP (reliability score 1), after 24 hr of exposure a considerable portion (59.51%) of 14C-DMSD applied in aqueous dosing solution volatilized from the skin surface and was captured in the charcoal baskets placed above the exposure site. The percent of applied 14C-DMSD recovered from all analysed samples was 91.66%. After 24 hr of exposure 18.27% of applied dose was found on the skin surface and 2.48% of applied dose remained in the skin after washing and tape stripping. The total percent dose absorbed was estimated to be 13.88% of applied dose.
The majority of the absorbed dose (82.1%) penetrated through the skin into receptor fluid with the estimated mean cumulative penetration of 11.7 ± 3.2 μg equivalents of 14C-DMSD /cm2 of exposed skin over the 24 hr diffusion period (11.40% of applied dose). The permeability coefficient (Kp) was estimated to be 2.0x10-4 cm/hr based on steady state flux established between 3 and 8 hours of exposure. It is considered appropriate to use this result as dichloro(dimethyl)silane hydrolyses rapidly to produce dimethylsilanediol and hydrogen chloride in contact with skin. - Executive summary:
In a well conducted in vitro dermal absorption study conducted to GLP (reliability score 1), after 24 hr of exposure a considerable portion (59.51%) of 14C-DMSD applied in aqueous dosing solution volatilized from the skin surface and was captured in the charcoal baskets placed above the exposure site. The percent of applied 14C-DMSD recovered from all analysed samples was 91.66%. After 24 hr of exposure 18.27% of applied dose was found on the skin surface and 2.48% of applied dose remained in the skin after washing and tape stripping. The total percent dose absorbed was estimated to be 13.88% of applied dose.
The majority of the absorbed dose (82.1%) penetrated through the skin into receptor fluid with the estimated mean cumulative penetration of 11.7 ± 3.2 μg equivalents of 14C-DMSD /cm2 of exposed skin over the 24 hr diffusion period (11.40% of applied dose). The permeability coefficient (Kp) was estimated to be 2.0x10-4 cm/hr based on steady state flux established between 3 and 8 hours of exposure. It is considered appropriate to use this result as dichloro(dimethyl)silane hydrolyses rapidly to produce dimethylsilanediol and hydrogen chloride in contact with skin.
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