Registration Dossier
Registration Dossier
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EC number: 265-929-8 | CAS number: 65799-47-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 5 June to 3 July 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with an appropriate guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- [3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane
- EC Number:
- 220-780-8
- EC Name:
- [3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane
- Cas Number:
- 2897-60-1
- Molecular formula:
- C11H24O4Si
- IUPAC Name:
- Diethoxy-methyl-[3-(oxiran-2-ylmethoxy)propyl]silane
- Reference substance name:
- [3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane
- IUPAC Name:
- [3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD) IGS BR VAF/Plus
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Inc., USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 154.4 to 181.2g
- Fasting period before study: yes
- Housing: individually in wire mesh cages
- Diet (ad libitum): LabDiet 5002, PMI
- Water (ad libitum): municipal water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.81 to 22.09
- Humidity (%): 40 to 66
- Air changes (per hr): 14.5
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 June 2008 To: 3 July 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: not stated
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not stated - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Frequency of weighing: day of dosing, weekly thereafter including the day of necropsy
- Necropsy of survivors performed: yes - Statistics:
- Body weight was reported as groups means and standard deviations, computed by Provantis v6.5
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In a study conducted according to an OECD test guideline and in compliance with GLP, administration of [3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane to female rats at 2000 mg/kg bw did not result in any remarkable findings and the LD50 was considered to be greater than 2000 mg/kg bw.
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