Potassium methylsilanetriolate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002/04/15 to 2002/05/16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Potassium methylsilanetriolate

EC Number:

250-807-9

EC Name:

Potassium methylsilanetriolate

Cas Number:

31795-24-1

Molecular formula:

CH6O3Si.xK

IUPAC Name:

tripotassium methylsilanetriolate

Test animals

Species:

rat

Strain:

other: CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Charles River Deutschland GmbH, D-97633, Sulzfeld

- Age at study initiation: 42-48 days

- Weight at study initiation: Males 210-219 g; Females 179-193 g

- Fasting period before study: Yes - 16 hours

- Housing: MAKROLON cages (Type III)

- Diet (e.g. ad libitum): ssnif R/M-H V 1530 ad libitum

- Water (e.g. ad libitum): ad libitum

- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 22 ± 3

- Humidity (%): 55 ± 15

- Air changes (per hr): No information

- Photoperiod (hrs dark / hrs light): 12


IN-LIFE DATES: From: 15th April 2002 To: 16th May 2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.54 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Guideline

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: 15 mins, 1, 3, 6 and 24 hours after dosing and daily thereafter for clinical observations; weekly for weighing

- Necropsy of survivors performed: Yes

- Other examinations performed: clinical signs, body weight, macroscopic examinations

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: All animals of each sex showed clinical signs of toxicity including slightly reduced motility, slight ataxia, slightly reduced muscle tone and slight dypsnoea up to 1 hour after administation of the test material.

Gross pathology:

No macroscopic abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

An acute oral LD50 value of >2000 mg/kg bw was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.