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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
A single oral adminitration of 5ml/kg of test substance to 10 male rats. Observation period 14 days.
GLP compliance:
no
Test type:
other: LD50
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Octamethylcyclotetrasiloxane (D4)

- Substance type: cyclic siloxane

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals 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:
No clinical signs.
Body weight:
No data available.
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 >5ml/kg (ca. 4800 mg/kg) was determined in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP.