Registration Dossier
Registration Dossier
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EC number: 252-558-1 | CAS number: 35435-21-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Days
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (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:
- Triethoxy(2,4,4-trimethylpentyl)silane
- EC Number:
- 252-558-1
- EC Name:
- Triethoxy(2,4,4-trimethylpentyl)silane
- Cas Number:
- 35435-21-3
- Molecular formula:
- C14H32O3Si
- IUPAC Name:
- triethoxy(2,4,4-trimethylpentyl)silane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Biological Research Laboratories.
- Age at study initiation: 8-10 weeks
- Weight at study initiation: Males: 206-216 g. Females: 171-190 g.
- Fasting period before study: Yes, overnight.
- Housing: Groups of three in Makrolon type-4 cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 40-66
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Justification for choice of vehicle: None given
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: None given. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Three
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical signs: four times per day on the day of treatment, and once daily thereafter. Body weights: Pre-administration and on Days 8 and 15.
- Necropsy of survivors performed: yes, on day 15 after observations.
- Other examinations performed: Macroscopic examination. - Statistics:
- No statistical analysis as no deaths occurred.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths occurred.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: There were no clinical signs.
- Gross pathology:
- No abnormal findings.
- Other findings:
- No other findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the acute oral toxicity study, conducted according to OECD Test Guideline 423 and in compliance with GLP, the LD50 for triethoxy(2,4,4-trimethylpentyl)silane was concluded to be >2000 mg/kg bw. No deaths occurred up to the highest dose tested.
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