Registration Dossier
Registration Dossier
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EC number: 214-685-0 | CAS number: 1185-55-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1963
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 963
- Report date:
- 1963
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- occlusive dressings used
- Principles of method if other than guideline:
- Method: other
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Trimethoxy(methyl)silane
- EC Number:
- 214-685-0
- EC Name:
- Trimethoxy(methyl)silane
- Cas Number:
- 1185-55-3
- Molecular formula:
- C4H12O3Si
- IUPAC Name:
- trimethoxy(methyl)silane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: 'produced locally'
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 2.5kg
- Diet: Rockland rabbit ration
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Type of wrap if used: vinylite or polyethylene sheeting - Duration of exposure:
- 24 hours
- Doses:
- 10 ml/kg
- No. of animals per sex per dose:
- 4
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- None
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 10 mL/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died (0/4).
- Clinical signs:
- other: Little skin irritation was observed but some desquamation was found after 14 days.
- Gross pathology:
- None reported.
- Other findings:
- None reported.
Any other information on results incl. tables
10 ml/kg is calculated to be 9500 mg/kg using the formula
ml/kg = mg/kg*density*1000, where density = 0.95
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 value of >10 ml/kg (>9500 mg/kg) for rabbits was reported in a reliable study conducted according to appropriate protocol. The study was not compliant with GLP.
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