Dodecamethylcyclohexasiloxane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999/05/11-1999/05/26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1999

Report date:

1999

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:

Dodecamethylcyclohexasiloxane

EC Number:

208-762-8

EC Name:

Dodecamethylcyclohexasiloxane

Cas Number:

540-97-6

Molecular formula:

C12H36O6Si6

IUPAC Name:

dodecamethylcyclohexasiloxane

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Charles River Deutschland, Germany

- Age at study initiation: ca. 6 weeks old

- Weight at study initiation: 147g females, 194g males

- Fasting period before study: over night

- Housing: Group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material

- Diet: standard pelleted laboratory animal diet, ad libitum

- Water: tap water, ad libitum

- Acclimation period: min. 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 21

- Humidity (%): 50

- Air changes (per hr): ca.15

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.22 ml/kg bw

Doses:

2000 mg/kg

No. of animals per sex per dose:

3M, 3F

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Mortality and viability was checked twice, daily. Body weights were recorded on day 1 (pre-administration), day 8 and day 15.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:Clinical signs were checked at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded. Macroscopic examination was performed after terminal sacrifice.

Statistics:

No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs of toxicity were noted. 

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute oral toxicity study, conducted according to the toxic class method OECD Test Guideline 423 and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was concluded.