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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984/08/15-1984/08/29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
other: LD50
Limit test:
yes

Test material

Constituent 1
Chemical structure
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/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Source: Winkelmann, Borchen

- Age at study initiation: 9-14 weeks

- Weight at study initiation: ca. 180g

- Housing: Conventional Makrolon type 3 cages

- Diet: Altromin R 1324 ad libitum

- Water: ad libitum




ENVIRONMENTAL CONDITIONS

- Temperature (°C): 22 +/- 1.5

- Humidity (%): 60 +/-5

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

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 2.5ml/kg bw


Duration of exposure:
Single instillation
Doses:
no data
No. of animals per sex per dose:
5 per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed twice daily during the 14 day observation period, and the beginning and intensity of symptoms recorded. The animals were weighed in the beginning, middle and end of the observation period.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: all animals were subjected to gross necropsy.
Statistics:
No statistical analysis was carried out.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2.5 mL/kg bw
Based on:
test mat.
Remarks on result:
other: (>2375 mg/kg) bw
Mortality:
No mortality.
Clinical signs:
No clinical signs.
Body weight:
No treatment related changes in body weight.
Gross pathology:
No treatment-related findings at necropsy.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute dermal LD50 value of >2.5 ml/kg (ca. 2375 mg/kg bw) was determined in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP.