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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:
26.09.1991 to 16.10.1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
other: EEC 84/449/EEC
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Organosilane Si 208
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: Stable
- Storage condition of test material: Closed container at room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG., D-4799 Borchen
- Age at study initiation: Males: 8 weeks; Females: 9 weeks.
- Weight at study initiation: Males: 151-167 g; Females: 135-147 g.
- Fasting period before study: 16 hours
- Housing: Macrolon cages, Type II
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-22.5
- Humidity (%): 40-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02.10.1991 To:16.10.1991

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 21.5 ml/kg
Doses:
5110 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: Animals were continuously observed for the first 4 to 6 hours after administration and then once daily. Mortality was checked twice daily. Body weights were recorded before the first dose and then on days 7 and 14, or after death.
- Necropsy of survivors performed: yes, a gross necropsy was performed on all animals. Macroscopic examinations included external appearance, body orifices, body cavities (thoracic and abdominal), and their contents.
Statistics:
None. LD50s were estimated.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 110 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The study report states that the LD50 for females is approximately 5110 mg/kg bw, however, only 1/5 females died. Therefore the author of this study record has concluded that the overall LD50 is at least 5110 mg/kg bw for males and females.
Mortality:
One female animal died on day 7 after administration.
Clinical signs:
Signs of intoxication were slight to moderate hypokinesia, diarrhoea and piloerection in male and female rats. In addition, individual female animals showed coordination disturbances, stilted gait, red encrusted snout, strenuous respiration, sunken sides and vocalisation on handling. In general symptoms were observed on days two to three. In one female, first symptoms appeared 160 minutes after administration. In individual females signs of toxicity lasted for 14 days or until death. In male animals symptoms lasted at most for three days.
Body weight:
Body weight reductions in males and females.
Gross pathology:
At necropsy no abnormalities were detected. Only in the deceased female rat the gastro-intestinal tract was severely autolytic.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study conducted to the now deleted OECD 401 and to GLP (reliability score 1) the LD50 for triethoxy(octyl)silane was at least 5110 mg/kg bw in rats. Signs of intoxication were slight to moderate hypokinesia, diarrhoea and piloerection in male and female rats. In addition, individual female animals showed coordination disturbances, stilted gait, red encrusted snout, strenuous respiration, sunken sides and vocalisation on handling. In general symptoms were observed on days two to three. In one female, first symptoms appeared 160 minutes after administration. In individual females signs of toxicity lasted for 14 days or until death. In male animals symptoms lasted at most for three days. There were body weight reductions in males and females. At necropsy no abnormalities were detected. Only in the deceased female rat the gastro-intestinal tract was severely autolytic.