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EC number: 213-914-1 | CAS number: 1066-40-6
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2007-10-16 to 2007-10-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
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: OECD Guideline 440 (Uterotrophic Bioassay in Rodents: A short-term screening test for oestrogenic properties) draft
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- Hydroxytrimethylsilane
- EC Number:
- 213-914-1
- EC Name:
- Hydroxytrimethylsilane
- Cas Number:
- 1066-40-6
- Molecular formula:
- C3H10OSi
- IUPAC Name:
- hydroxytrimethylsilane
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, United States
- Age at study initiation: 42 days old
- Weight at study initiation: 248.4 - 312.6
- Fasting period before study: food was not provided during the inhalation exposure
- Housing: individually in a suspended wire-mesh cages
- Diet: Certified rodent diet, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8-21.7°C
- Humidity (%): 47-61 %
- Air changes (per hr): 10-15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 1000-liter stainless steel and glass, TSE-system, whole body inhalation exposure chamber
- Method of holding animals in test chamber: Animals were individually placed within stainless steel exposure caging specifically designed for use in the TSE-system chambers. Animals were positioned on the top level within each chamber with individual cage assignment rotated daily. The maximum number of animals per chamber did not exceed 5% of the total chamber volume.
- Source and rate of air: Airflow through the chamber inlet port
- Method of conditioning air: Compressed air was passed through a series of filters to remove contaminants. Conditioned building air was passed through a HEPA and activated charcoal filter before delivery to the chamber.
- System of generating vapour: Chamber concentration of vapour were generated using heated stainless steel J-tubes containing stainless steel beads for increased surface area. A Fluid Metering Inc. (FMI) pump was used to deliver liquid of test substance to the J-tube where it was mixed with a constant stream of filtered compressed air for vaporization. The resulting vapour/air mixture was swept into the chamber inlet for further dilution of the targeted exposure concentration. During each exposure, the J-tube temperature was continuously monitored and values were recorded minimum once during each day of vapour generation.
- Temperature, humidity, pressure in air chamber: Temperature and humidity were measured using a TSE-systems sensor. During the exposure, temperature and humidity were continuously monitored with values recorded every 30 min. The chamber temperature and humidity were maintained at 22 +/- 3 °C and 30-70 %, respectively throughout the exposure period. Oxygen was monitored using a TSE-system oxygen meter. During each exposure, oxygen content was continuously monitored with values recorded every 30 minutes. A minimum concentration of 19% was considered acceptable during the exposure period.
- Air flow rate: chamber airflow rate was measured using a mass-flow meter positioned in-line with the chamber supply air.
- Air change rate: The chamber was operated at an airflow rate appropriate for producing 12-15 chamber air changes per hour.
- Method of particle size determination: no data
- Treatment of exhaust air: no data
TEST ATMOSPHERE
- Brief description of analytical method used: Homogeneity was evaluated by sampling different locations within the chamber during generation of target vapour concentrations. The chamber atmosphere was considered acceptable if the location to location variation was within 10 % of the measured concentration at the reference location. The reference location was representative of the normal sample analysis position anticipated during the exposure interval. Test atmosphere monitoring utilized gas chromatographic analysis with flame ionization detector.
- Samples taken from breathing zone: no data
VEHICLE (if applicable)
- Justification for use and choice of vehicle: The stability of the materials in corn oil has been characterised over an 8-day period using scientifically valid methods.
- Lot/batch no. of vehicle (if required): 126K0117
POSITIVE CONTROL:
Positive control article 1: 17α-Ethynyl estradiol (EE)
Positive control article 2: Genistein
Anti-estrogen control: ICI 182, 780 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration verification of the dose solutions (EE, ICI and genistein) was performed prior to the start of dosing. Due to analytical sensitivity limitations, only 1 mg/ml stock solution of EE was analysed. The ICI was quantified in the mixture of EE and ICI. The test article weight was determined pre- and post-exposure. These data, along with the chamber airflow rate and generation time were used to calculate a nominal chamber concentration of test article. Chamber concentrations were evaluated at least once per hour during each exposure.
- Duration of treatment / exposure:
- 6 hours/day
- Frequency of treatment:
- daily
- Duration of test:
- 3 days
Doses / concentrations
- Dose / conc.:
- 600 ppm (nominal)
- Remarks:
- 600 ppm trimethylsilanol with and without 3 µg/kg bw/day ethynyl estradiol administered subcutaneously
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Details on study design:
- Dosing began 20 days following surgery. Control groups (1-8) (see Table 1), EE/TMS combined group and TMS groups received subcutaneous doses of corn oil, EE, genistein or EE+ICI for three consecutive days. The volume of the dosing solutions did not exceed 2 ml/kg. The dose was adjusted daily according to body weight. Different injection site was used each day. After subcutaneous injection, the control rats (groups 1-8) were placed in chambers for whole body inhalation exposure to filtered air for 6 hours/ day. Treatment groups (1-10) were placed in 600 ppm TMS chamber for 6 hours/day. On day 4 from the study period all rats were sacrificed by carbon dioxide asphyxiation.
- Statistics:
- - ANOVA was used for analysis of differences in uterine weights.
- LSMEANS was used to determine statistically significant treatment effects
Results and discussion
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- > 600 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Exposure to trimethylsilanol did not elicit either an estrogenic or anti-estrogenic response.
Observed effects
Body weight and weight gain: no effects
Organ weights: no effects
Gross pathology: no effects
Any other information on results incl. tables
CLINICAL
SIGNS AND MORTALITY: No test-article related clinical signs of toxicity
were observed. All animals survived throughout the study period.
BODY
WEIGHT AND WEIGHT GAIN: No treatment-related effects on body weight were
noted.
ORGAN
WEIGHTS: Treatment with EE and genistein resulted in increase in uterine
weight. EE induced a statistically significantly dose-responsive
increase in the uterine weight. Genistein also increased the uterine
weight, however statistical significance was achieved only by the
high-dose. The ICI antagonist blocked the expected EE increase in
uterine weight. Exposure to 600 ppm TMS did not induce a statistically
significant increase in uterine weight. TMS also had no effect on the
EE-induced increase in uterine weigh.
Applicant's summary and conclusion
- Conclusions:
- In the uterotrophic assay the test material, trimethylsilanol, did not elicit estrogenic or anti-estrogenic responses after whole body inhalation exposure for 6 hours per day for 3 consecutive days.
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