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EC number: 242-042-4 | CAS number: 18162-48-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April to 28 June 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 018162-48-6
- Cas Number:
- 018162-48-6
- IUPAC Name:
- 018162-48-6
- Reference substance name:
- tert-butylchlorodimethylsilane
- EC Number:
- 242-042-4
- EC Name:
- tert-butylchlorodimethylsilane
- Cas Number:
- 18162-48-6
- Molecular formula:
- C6H15ClSi
- IUPAC Name:
- tert-butyl(chloro)dimethylsilane
- Test material form:
- solid: crystalline
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: CD/Crl:CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Germany
- Age at study initiation: 41 or 42 days
- Weight at study initiation: 194-231 g (males), 175-208 g (females)
- Fasting period before study: yes
- Housing: Makrolon Type III cages with granulated textured wood (Granulate A2) bedding
- Diet (ad libitum): ssniff R/M-H V 1530
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: June 2002
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- stability in vehicle: > 1 day at +4 degrees C in the dark - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: pre-dose, 5, 15, 30 and 60 minutes, 3, 6 and 24 hours after dosing, then daily. Body weights: weekly
- Necropsy of survivors performed: yes - Statistics:
- Means and standard deviations
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One male found dead on Day 3
- Clinical signs:
- other: One female was noted to have reduced mobility, ataxia and slightly reduced muscle tone between 15 and 60 minutes after dosing.
- Gross pathology:
- In the male that died on Day 3, intestine filled with gas and dark contents was recorded.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of tert-butyl(chloro)dimethylsilane in CD rats was greater than 2000 mg/kg in a study conducted according to OECD 423 and in compliance with GLP.
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