Diacetoxydi-tert-butoxysilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diacetoxydi-tert-butoxysilane

EC Number:

236-112-3

EC Name:

Diacetoxydi-tert-butoxysilane

Cas Number:

13170-23-5

Molecular formula:

C12H24O6Si

IUPAC Name:

(acetyloxy)bis(tert-butoxy)silyl acetate

Test material form:

not specified

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Stamm Wistar TNO W 74, Zuchter: Winkelmann, Borchen.
- Age at study initiation: 9 weeks.
- Weight at study initiation: 179g.
- Fasting period before study: No data
- Housing: Makrolon Type III cage.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: No vehicle. Administered undiluted.
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw

DOSAGE PREPARATION (if unusual): No data

Doses:

3.1 or 5.0 ml/kg bw. (converts to 2616 and 4220 mg/kg bw using a density of 0.844 g/cm3).

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of application, followed by twice daily (once at weekends/public holidays).
- Necropsy of survivors performed: no
- Other examinations performed: body weights were recorded on the day of administration and on day 14 of the observation period.

Statistics:

No data

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

>= 5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Deaths at the LD50 dose occurred in 2/10 animals within 2-4 days. No other deaths recorded. All animals given this dose showed signs of weight loss and sedation.

Mortality:

No deaths were observed following a dose of 3.1 ml/kg bw (2616 mg/kg bw).
In the high dose group (5 ml/kg bw equal to 4220 mg/kg bw) there was one death on day 2 and one death on day 4 following administration of the test substance.

Clinical signs:

other: No clinical signs were observed following a dose of 3.1 ml/kg bw (2616 mg/kg bw) Sedation was observed in animals administered the highest dose of 5 ml/kg (4220 mg/kg bw).

Gross pathology:

No necropsy conducted.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on a summary of an acute oral gavage toxicity study (reliability score 2) the LD50 for diacetoxydi-tert-butoxysilane is 5ml/kg bw in Wistar rats. Using a density of (1.33g/cm3 the LD50 is converted to 6650 mg/kg bw.