Decamethylcyclopentasiloxane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

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:

The test was conducted based upon the Federal Hazardous Substances Act - Consumer Product Safety Commission, 16 CFR, Part 1500, Chapter 2, Subpart C, Section 1500.3, 1990.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decamethylcyclopentasiloxane

EC Number:

208-764-9

EC Name:

Decamethylcyclopentasiloxane

Cas Number:

541-02-6

Molecular formula:

C10H30O5Si5

IUPAC Name:

2,2,4,4,6,6,8,8,10,10-decamethyl-1,3,5,7,9,2,4,6,8,10-pentoxapentasilecane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Charles River Breeding laboratories (Wilmington, MA)

- Age at study initiation: 8-12 weeks old

- Weight at study initiation: 200-300 g bw

- Fasting period before study: overnight

- Housing: individually housed using stainless steel cages

- Diet: commercial rodent ration, ad libitum

- Water: municipal tap water, ad libitum

- Acclimation period: 3 day quarantine upon receipt



ENVIRONMENTAL CONDITIONS

- Temperature (°F): 68 +/-3

- Humidity (%): 30-70

- Air changes (per hr): min. 10-13

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data available.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Clinical observations were conducted daily and included all toxicologic and pharmacologic signs including nature, onset, severity and duration of abnormal or unusual cardiovascular, respiratory, excretory, behavioural and other activities, as well as signs including adverse effect on the central nervous system (paralysis, lethargy, lack of coordination and staggering) and time of death. Individual body weights were determined on the fasted animals on day 0 (shortly before the test article was administered) and again on study day 7 and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: A gross necropsy was performed on all animals on day 14.

Statistics:

No statistical analysis performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities.

Clinical signs:

other: There were no overt signs of toxicity noted in any test animal during the observation period.

Gross pathology:

No unusual lesions were noted in any of the animals at necropsy.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute oral LD50 value of >5000 mg/kg for male and female rats was determined in a reliable study conducted according to an appropriate test protocol.