Octamethylcyclotetrasiloxane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

A single oral administration of 5 ml/kg of test substance to 10 male rats. Observation period 14 days.

GLP compliance:

no

Test type:

other: LD50

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octamethylcyclotetrasiloxane

EC Number:

209-136-7

EC Name:

Octamethylcyclotetrasiloxane

Cas Number:

556-67-2

Molecular formula:

C8H24O4Si4

IUPAC Name:

2,2,4,4,6,6,8,8-octamethyl-1,3,5,7,2,4,6,8-tetroxatetrasilocane

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Wikelmann

- Weight at study initiation: 160-180g

- Housing: 5 animals per cage

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No detail available.

Doses:

5.0 ml/kg bw

No. of animals per sex per dose:

10M

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: no detail available

- Necropsy of survivors performed: not specified

- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: No detail available.

Statistics:

No statistical analysis reported.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 4 800 mg/kg bw

Based on:

test mat.

Remarks on result:

other: > 5.0 ml/kg bw (> 4800 mg/kg bw)

Mortality:

No mortality.

Clinical signs:

other: No clinical signs.

Gross pathology:

None reported.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute oral LD50 value of > 5 ml/kg (ca. 4800 mg/kg) was determined in male rats in a reliable non-GLP study conducted according to an appropriate test protocol.