Triethoxyoctylsilane

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC 84/449/EEC

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxyoctylsilane

EC Number:

220-941-2

EC Name:

Triethoxyoctylsilane

Cas Number:

2943-75-1

Molecular formula:

C14H32O3Si

IUPAC Name:

triethoxy(octyl)silane

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system 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:

other: 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

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 in compliance with 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.