Registration Dossier
Registration Dossier
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EC number: 210-535-3 | CAS number: 617-86-7
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-07-06 to 2001-07-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The highest concentration tested was not the maximum achievable concentration.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- 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:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, North Carolina, RO2 Facility
- Age at study initiation: 8-9 weeks
- Weight at study initiation: Females: 128.3 - 134.3g; males: 166.1 - 173.4g
- Fasting period before study: no data
- Housing: Suspended wire-mesh cages above Bed-O'Cob bedding
- Diet: Purina Rodent Chow ad libitum
- Water: reverse osmosis treated tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 66-77°F, equivalent to 19-25°C
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: approximately 10th June to: 20th July 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: Rochester-type, stainless steel and glass whole-body exposure chamber
- Exposure chamber volume: 450 litres
- Method of holding animals in test chamber: stainless steel wire mesh cages
- Source and rate of air: compressed air from Nash compressor at approx. 116 L/min
- Method of conditioning air: passed through Wilkerson model WRA-0025-01-1 dehumidifier and particulate filters (Matheson 460, Balston A915A-DX, A915A-Bx
- System of generating vapour: test article supplied in cylinder as liquefied gas. The cylinder was inverted such that the test article exited as a liquid, which was directed via stainless steel tubing to a heat-reacted (40-60 degrees C) metal J-tube containing a column of stainless steel ball bearings. A stream of compressed air was passed through the J-tube. The test article entering the J-tube was mixed with the air stream and then directed into the chamber inlet.
- Method of particle size determination: not applicable.
- Treatment of exhaust air: not stated
- Temperature, humidity, pressure in air chamber: 22.3 - 23.7 degrees C, 45.8-51.3% RH, -0.6" water.
TEST ATMOSPHERE
- Brief description of analytical method used: GC/FID
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 1774 ppm (1738-1827 ppm)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed at least once daily, weighed Days 1, 8 and 15
- Necropsy of survivors performed: yes - Statistics:
- Group mean values and standard error of the mean calculated by Microsoft Excel where appropriate.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1 774 ppm
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Equivalent to > 5400 mg/m³
- Mortality:
- None
- Clinical signs:
- other: None considered to be test article-related.
- Body weight:
- No treatment-related effects.
- Gross pathology:
- No treatment-related effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Trimethylsilane has been tested in accordance with OECD 403 and in compliance with GLP. No treatment-related effects were observed. It is concluded that the whole-body vapour inhalation LC50 value for trimethylsilane in the Fischer 344 rat is greater than 1774 ppm (5.4 mg/L, 5400 mg/m³), the highest concentration tested.
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