Triethoxyisobutylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18.03.1987 to 01.04.1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no controls

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxyisobutylsilane

EC Number:

402-810-3

EC Name:

Triethoxyisobutylsilane

Cas Number:

17980-47-1

Molecular formula:

Hill formula: C10H24O3Si CAS formula: C10H24O3Si

IUPAC Name:

triethoxy(2-methylpropyl)silane

Details on test material:

- Name of test material (as cited in study report): Isobutyltriethoxysilane
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: Not determined
- Storage condition of test material: Ambient temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd., UK.
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 94-122 g
- Fasting period before study: yes, overnight
- Housing: Groups in metal cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Six days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 47
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 18.03.1987 to 01.04.1987

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: No data

Doses:

5000 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 observed soon after dosing, then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed twice per day. Body weights were measured on days 1 (day of dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Surviving animals were killed on day 15, and animals that died were examined macroscopically.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No test substance-related deaths.

Mortality:

One animal died on day 6 due to a dosing error. There were no other deaths.

Clinical signs:

other: Signs of reaction to treatment observed in all rats shortly after dosing were piloerection, abnormal body carriage (hunched posture) and abnormal gait (waddling). Only piloerection persisted on Day 2. There were no other clinical signs, and recovery was c

Gross pathology:

No abnormal findings.

Other findings:

- Organ weights: Not measured.
- Histopathology: Not conducted.
- Potential target organs: None identified.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study conducted using a protocol comparable to the now deleted OECD 401 (reliability score 1) the LD50 for triethoxyisobutylsilane was >5000 mg/kg bw in rats. Signs of reaction to treatment observed in all rats shortly after dosing were piloerection, abnormal body carriage (hunched posture) and abnormal gait (waddling). Only piloerection persisted on Day 2. There were no other clinical signs, and recovery was complete by Day 3. There were no abnormal findings at necrospy.