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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In an inhalation Combined Repeated Dose Toxicity Study with Reproductive/Developmental Toxicity Screening Test (WIL, 2008) conducted to OECD Test Guideline 422 and in compliance with GLP, there were no adverse effects on maternal animals and no adverse effects on reproduction parameters. Therefore, under the conditions of this screening study, an exposure level of ≥600 ppm (≥2249.82 mg/m3) trimethylsilanol was considered to be the NOAEL for parental general toxicity and reproductive toxicity.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 2 249.82 mg/m³
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In
an inhalation Combined Repeated Dose Toxicity Study with
Reproductive/Developmental Toxicity Screening Test (WIL, 2008) conducted
to OECD Test
Guideline
422 and in compliance with GLP, three groups of Sprague-Dawley rats,
were exposed via whole-body inhalation to vapour atmospheres of
trimethylsilanol, 6 hours/day, 7 days/week. Target exposure
concentrations were 60, 300 and 600 parts per million
(ppm). Treatment-related effects were limited to changes in haematology
(lower eosinophil and lymphocyte counts for males) and serum chemistry
(higher alanine aminotransferase for males and toxicity phase females)
at 600 ppm. These changes occurred in the absence of correlating
histologic changes and were not considered adverse. Mean
mating, fertility and copulation/conception indices for all exposure
concentrations were similar to the control group. Mean gestation
lengths, postnatal survival and F1 body weights were similar
to the control group. Therefore,
under the conditions of this screening study, an exposure level of
600 ppm (≥2249.82 mg/m3) trimethylsilanol was
considered to be the NOAEL for parental general toxicity and
reproductive toxicity. Trimethylsilanol has also been
tested in a valid uterotrophic assay, conducted according to OECD TG 440
(draft), and in compliance with GLP, for ability to induce estrogenic or
antiestrogenic effects in female rats (Dow Corning Corporation, 2008).
Exposure of rats to 600 ppm of test substance for 6 hours per day for 3
consecutive days did not induce any changes in uterine weight or any
estrogenic or anti-estrogenic response. Positive and negative controls
were also included and gave the expected results.
Effects on developmental toxicity
Description of key information
In an oral prenatal developmental toxicity study (Harlan, 2014) conducted to OECD 414 and in compliance with GLP, administration of trimethylsilanol by oral gavage to Sprague-Dawley rats from Day 6 to 20 of pregnancy at 0, 50, 150 or 450 mg/kg/day resulted in a NOAEL for maternal and developmental toxicity of 150 mg/kg bw/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The key study was conducted according to OECD Test Guideline 414 and in compliance with GLP.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 2 249.82 mg/m³
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The inhalation study was conducted to OECD test guideline 422 and in compliance with GLP.
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In an oral prenatal developmental study (Harlan, 2014) conducted to OECD 414 and in compliance with GLP, administration of trimethylsilanol by oral gavage to Sprague-Dawley rats from Day 6 to 20 of pregnancy at doses of 0, 50, 150 or 450 mg/kg/day resulted in maternal toxicity (reduced corrected body weight gains) at 450 mg/kg bw/day.
Reduced fetal weight, delayed ossification and increased incidence of some cartilaginous variations were noted in fetuses at 450 mg/kg/day. The slight delay in ossification at the LOAEL of 450 mg/kg bw/day correlates with the lower fetal body weight which again correlates with the decrease in food consumption, and in mean absolute body weight and body weight gain of the parental animals. Thus, the findings are a secondary effect in response to the treatment related maternal effects observed at this dose level.
The increased incidence of supernumerary rudimentary ribs, long ventral plate and long or interrupted costal cartilage at 450 mg/kg are reported as variations with high spontaneous incidence in this strain and therefore neither adverse nor an indication for a biologically relevant disturbance of the fetal development. Therefore, the findings at 450 mg/kg do not trigger classification for developmental toxicity and the NOAEL for maternal and developmental toxicity was considered to be 150 mg/kg bw/day.
No adverse effects on developmental parameters were observed in an
inhalation Combined Repeated Dose Toxicity Study with
Reproductive/Developmental Toxicity Screening Test (WIL, 2008) conducted
to OECD test guideline 422 and in compliance with GLP. The NOAEC for
trimethylsilanol in this study was ≥600ppm
(2249.82 mg/m3).
Justification for classification or non-classification
Based on the available studies there is no requirement for the classification of trimethylsilanol for adverse effects on reproduction or development according to Regulation (EC) No 1272/2008.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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