Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 213-603-0 | CAS number: 993-07-7
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 January 2001 to 27 February 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Conducted according to a guideline similar to OECD 412. Original report in Japanese, English translation available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guidelines on Industrial Chemicals (Kanpogyo no. 5, Yakuhatsu no. 615, 49Kikyoku no. 392, 1971; Revised Kanpogyo no. 700, Yakuhatsu no. 1039, 61Kikyoku no. 1014, 1986
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- yes
- Remarks:
- full tissue list not examined
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Trimethylsilane
- EC Number:
- 213-603-0
- EC Name:
- Trimethylsilane
- Cas Number:
- 993-07-7
- Molecular formula:
- C3H10Si
- IUPAC Name:
- trimethylsilane
- Test material form:
- gas
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Japan Inc
- Age at study initiation: 5 weeks
- Weight at study initiation: males 154 - 202g, females 117 - 155g
- Fasting period before study: no
- Housing: up to 2 of same sex in polycarbonate cages with sterilized hard wood bedding
- Diet (ad libitum): pelleted diet (MF, Oriental Yeast Industry Co.)
- Water (ad libitum): tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1 - 24.6
- Humidity (%): 33.6 - 61.2
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16 January 2001 To: 27 February 2001
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Vehicle:
- clean air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 95 L inhalation chamber
- Method of holding animals in test chamber: individually in wire mesh cages
- Source and rate of air: compressed air at 20 L/min
- Method of conditioning air: not stated
- System of generating vapour: the test substance gas was filled in a high pressure gas cylinder, adjusted to 0.08 MPa, was then diluted with clean compressed air top prepare the gas at a concentration of 5.0 mg/L. This was diluted serially to each target concentration, and each dilution fed into the inhalation chamber by the one-pass method.
- Temperature, humidity, oxygen concentration in chamber: 23.0 - 25.2 degrees C, 32% - 53% RH, 20.6 - 21.0%
- Air flow rate: 20 L/min
- Air change rate: 12.6 air changes/hour
- Method of particle size determination: not applicable - gas
- Treatment of exhaust air: not stated
TEST ATMOSPHERE
- Brief description of analytical method used: hydrocarbon meter (HCM-1B, Shimadzu Corporation) and FID gas chromatography
- Samples taken from breathing zone: no (exhaust gas analysed) - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Hydrocarbon meter and FID gas chromatography (no further details given).
- Duration of treatment / exposure:
- 28 days followed by 14 day recovery period for subgroup of Control and high dose animals
- Frequency of treatment:
- daily, 6 hours per day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.19 mg/L air (analytical)
- Remarks:
- 0.2 mg/L (nominal)
- Dose / conc.:
- 0.87 mg/L air (analytical)
- Remarks:
- 1.0 mg/L (nominal)
- Dose / conc.:
- 4.73 mg/L air (analytical)
- Remarks:
- 5.0 mg/L (nominal)
- No. of animals per sex per dose:
- 12 for Control and high dose, 6 for low and intermediate dose
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: 14-day dose range finding study, no effects noted up to 5 mg/L
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily (before and after treatment)
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: once weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/rat/day: Yes
- Time schedule for examinations: once weekly
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: prior to necropsy (Days 29 or 43)
- Anaesthetic used for blood collection: Yes (thiopental sodium)
- Animals fasted: Yes
- How many animals: all
- Parameters checked in table No.1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: prior to necropsy (Days 29 or 43)
- Animals fasted: Yes
- How many animals: all
- Parameters checked in table No.2 were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: Day 24
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table No.3 were examined.
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table)
HISTOPATHOLOGY: Yes (see table) - Statistics:
- The significance of differences in mean data was assessed by multiple comparison. The data were tested for homogeneity of variance by Bartlett's test. If the variance was homogenous, possible intergroup differences were assessed by the one-way analysis of variance. If the variance was heterogenous, possible intergroup differences were assessed by the Kruskal-Wallis test. If any significant intergroup differences were detected, the subsequent identification of the groups was carried out by Dunnett's method or Dunnett-type multiple comparison. The significance of differences in counted data was assessed by the a x b Chi-square test. If a significant difference was noted, each dose group was compared with the control group by Armitage's Chi-square test. Differences with P<0.05 were considered statistically significant.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: no effect of treatment.
BODY WEIGHT AND WEIGHT GAIN: no effect of treatment.
FOOD CONSUMPTION: no effect of treatment.
HAEMATOLOGY: lower activated partial thromboplastin time noted in 4.73 mg/L females but was within historical control range and therefore considered unrelated to treatment.
CLINICAL CHEMISTRY: higher potassium and lower urea nitrogen and higher chloride were noted but as none of these changes were noted in the high dose group, were considered unrelated to treatment.
URINALYSIS: no effect of treatment.
ORGAN WEIGHTS: higher relative spleen weight noted at end of recovery period for high dose females. As this was not noted at the end of the treatment period, or in males, it was considered to be unrelated to treatment.
GROSS PATHOLOGY: no effect of treatment.
HISTOPATHOLOGY: NON-NEOPLASTIC: at the end of treatment and recovery, histopathological examination revealed changes including focal myocardial degeneration/fibrosis in the heart, capsulitis and development of germinal centres in the spleen, accumulation of foam cells and osseous metaplasia in the lungs, periportal fatty change in hepatocytes, focal inflammatory cell infiltration and microgranuloma in the liver, basophilic proximal tubules, cysts, dilatation of the pelvis, focal fibrosis, hyaline droplets in the epithelium of proximal tubules, focal lymphocyte infiltration in the interstitum and mineralization in the corticomedullary junction or medulla in the kidneys, diffuse atrophy of seminiferous tubules in the testes and hyperplasia of Rathket's pouch in the posterior lobe of the pituitary. These changes were considered to be unrelated to treatment as they were spontaneous changes in rats and because there was no clear group-related difference in incidence or severity.
Effect levels
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 4 730 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects noted up to 4.73 mg/L, the highest concentration tested.
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Repeat-dose inhalation administration of trimethylsilane to rats by whole-body exposure for 28 consecutive days did not result in any findings attributable to treatment. The No-Observed-Adverse-Effect-Concentration (NOAEC) was therefore considered to be 4730 mg/m3 (4.73 mg/L), the highest concentration tested.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.