tert-butylchlorodimethylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 April to 28 June 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

018162-48-6

Cas Number:

018162-48-6

IUPAC Name:

018162-48-6

Constituent 2

Reference substance name:

tert-butylchlorodimethylsilane

EC Number:

242-042-4

EC Name:

tert-butylchlorodimethylsilane

Cas Number:

18162-48-6

Molecular formula:

C6H15ClSi

IUPAC Name:

tert-butyl(chloro)dimethylsilane

Test material form:

solid: crystalline

Test animals

Species:

rat

Strain:

other: CD/Crl:CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River GmbH, Germany
- Age at study initiation: 41 or 42 days
- Weight at study initiation: 194-231 g (males), 175-208 g (females)
- Fasting period before study: yes
- Housing: Makrolon Type III cages with granulated textured wood (Granulate A2) bedding
- Diet (ad libitum): ssniff R/M-H V 1530
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: June 2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- stability in vehicle: > 1 day at +4 degrees C in the dark

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: pre-dose, 5, 15, 30 and 60 minutes, 3, 6 and 24 hours after dosing, then daily. Body weights: weekly
- Necropsy of survivors performed: yes

Statistics:

Means and standard deviations

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male found dead on Day 3

Clinical signs:

other: One female was noted to have reduced mobility, ataxia and slightly reduced muscle tone between 15 and 60 minutes after dosing.

Gross pathology:

In the male that died on Day 3, intestine filled with gas and dark contents was recorded.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of tert-butyl(chloro)dimethylsilane in CD rats was greater than 2000 mg/kg in a study conducted according to OECD 423 and in compliance with GLP.