Reaction mass of 1,1,1,5,5,5-hexamethyl-3-phenyl-3-((trimethylsilyl)oxy)trisiloxane and 1,1,1,7,7,7-hexamethyl-3,5-diphenyl-3,5-bis[(trimethylsilyl)oxy]tetrasiloxane and 1,1,1,9,9,9-hexamethyl-3,5,7-triphenyl-3,5,7-tris((trimethylsilyl)oxy)pentasiloxane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-09-07 to 1994-09-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: TSCA 40 CFR Pt 798.1175

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

other: liquid

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, United States
- Age at study initiation: 49 - 74 days old
- Weight at study initiation: 200 - 300 g
- Fasting period before study: food was withheld on the night prior to dosing
- Housing: The animals were housed in groups in polycarbonate cages.
- Diet: commercial rodent ration, ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 68±30°F
- Humidity (%): 30-70 %
- Air changes (per hr): 10 to 13 air changes/ hour
- 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: The volume dosed did not exceed 1 ml/100 g bw

Doses:

5 g/kg bw administered in three fractional doses within 24 hours.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations; test animals were weighed on days 7 and 14 prior to sacrifice
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Statistics:

No data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

No evidence of toxicity at >=5000 mg/kg bw

Mortality:

No mortality was observed during the 14-day study period.

Clinical signs:

other: No signs of toxicity were noted in any of the animals during the observation period.

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral study the reported LD50 value for 1,1,5,5,5-hexamethyl-3-phenyl-3-[(trimethylsilyl)oxy]trisiloxane was > 5000 mg/kg bw.