Dibutoxy(dimethyl)silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to current OECD test guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dibutoxy(dimethyl)silane

EC Number:

216-467-0

EC Name:

Dibutoxy(dimethyl)silane

Cas Number:

1591-02-2

Molecular formula:

C10H24O2Si

IUPAC Name:

dibutoxydimethylsilane

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 9 - 10 weeks old
- Weight at study initiation: 143 - 174 g
- Fasting period before study: food was withheld from the test animals for 16 to 19 hours (access to water was permitted).
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 12/12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The dose volume was based on the individual animal’s body weight and was corrected for the density of the test item.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Clinical signs investigated several times on the day of dosing. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities.

Clinical signs:

other: Clinical signs were minimal, including slight to moderate piloerection, and slightly reduced spontaneous activity.

Gross pathology:

There were no specific findings at necropsy.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of >2000 mg/kg bw is reported for rats in a study conducted according OECD TG 423 and in compliance with GLP.

Executive summary:

Under the conditions of the present study, a single oral application of the test item dibutoxy(dimethyl)silane to rats at a dose of 2000 mg/kg body weight was associated with slight signs of toxicity but no mortality.