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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18.08.1994 to 08.09.1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[3-(2,3-epoxypropoxy)propyl]triethoxysilane
EC Number:
220-011-6
EC Name:
[3-(2,3-epoxypropoxy)propyl]triethoxysilane
Cas Number:
2602-34-8
Molecular formula:
C12-H26-O5-Si
IUPAC Name:
triethoxy[3-(oxiran-2-ylmethoxy)propyl]silane
Details on test material:
- Name of test material (as cited in study report): Wacker Silane GF 82
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: Stable
- Storage condition of test material: In original container, kept closed, at room temperature away from direct sunlight, acids, bases and oxidising agents.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Switzerland
- Age at study initiation: Males: 8 weeks; Females: 10 weeks
- Weight at study initiation: Males: 198.4 - 210.4 g; Females: 176.8-181.4 g
- Fasting period before study: yes
- Housing: Groups of five in Makrolon type IV cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ±2
- Humidity (%): 49-72
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25.08.1994 To: 08.09.1994

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2-15. Body weights were recorded on test day 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination only

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths
Mortality:
No deaths occurred.
Clinical signs:
other: There were no clinical signs of toxicity.
Gross pathology:
No abnormal findings .
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
In an acute oral toxicity study conducted to OECD Test Guideline 401 and in compliance with GLP (reliability score 1) the LD50 for [3-(2,3-epoxypropoxy)propyl]triethoxysilane was >2000 mg/kg bw in rats.