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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:
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
other: TSCA 40 CFR Pt 798.1175
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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.
Mortality:
No mortality was observed during the 14-day study period.
Clinical signs:
No signs of toxicity were noted in any of the animals during the observation period.
Body weight:
All animals gained weight 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.