Registration Dossier
Registration Dossier
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EC number: 222-217-1 | CAS number: 3388-04-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 962
- Report date:
- 1962
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- other: unclear
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane
- EC Number:
- 222-217-1
- EC Name:
- 2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane
- Cas Number:
- 3388-04-3
- Molecular formula:
- C11H22O4Si
- IUPAC Name:
- trimethoxy[2-(7-oxabicyclo[4.1.0]hept-3-yl)ethyl]silane
- Details on test material:
- - Name of test material (as cited in study report): 3,4-epoxy cyclohexylethyl trimethoxysilane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Carworth Farms-Elias
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: the laboratory in concern
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 90-120 grams
- Fasting period before study:
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: Up to 1.9 ml or 0.96 ml per rat (to achieve 16 ml/kg or 8 ml/kg respectively)
- Doses:
- 16 ml/kg, 8 ml/kg
- No. of animals per sex per dose:
- 5 males
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- No details are given in this very brief summary.
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 12.3 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: equivalent to 13161 mg/kg (based on density of 1.07 g/cm3)
- Mortality:
- Most deaths occurred shortly after dosing (no further detail available).
- Clinical signs:
- other: The animals became prostrate soon after dosing.
- Gross pathology:
- Congested lungs, kidneys, stomachs, intestines and pale mottled livers with prominent acini.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An acute oral LD50 of 12.3 ml/kg bw (equivalent to approximately 13161 mg/kg based on a density of 1.07 g/cm3), is reported in a study conducted according to a protocol equivalent to guideline but not in compliance with GLP.
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