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Diss Factsheets

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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Remarks:
Although a GLP statement was not included with the report, it is known that Bushy Run Research Center (BRRC) operated as a GLP-facility at the time the testing was conducted.
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trichloro(methyl)silane
EC Number:
200-902-6
EC Name:
Trichloro(methyl)silane
Cas Number:
75-79-6
Molecular formula:
CH3Cl3Si
IUPAC Name:
trichloro(methyl)silane

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 200-300g

- Fasting period before study: overnight

- Diet: commercial diet, ad libitum

- Water: municipal water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Silicone L-45 oil
Details on oral exposure:
Hiltop-Wistar albino rats received the test material as a 25% dilution in Silicone L-45 oil by stomach intubation with a ball-end stainless steel needle.
Doses:
The test material was administered undiluted t first at 0.25 ml/kg to males and 1 ml/kg to females. It was then administered as a dilution in Silicone L-45 Oil as follows; 8, 4, 2, 1, and 0.5 mL/kg in males; 8, 4, 2, and 1 mL/kg in females.
No. of animals per sex per dose:
5 animals/sex/dose for a total of 45 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Animal weights were recorded at 0 days (before dose), 7 days and 14 days (just prior to sacrifice).

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:
LD50s were calculated by the moving average method (Thompson, 1947) and were based on a 14-day observation period.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1.62 mL/kg bw
95% CL:
0.903 - 2.92
Remarks on result:
other: sample dosed as a 25% dilution in Silicone L-45 oil
Sex:
female
Dose descriptor:
LD50
Effect level:
2.83 mL/kg bw
95% CL:
2.09
Remarks on result:
other: sample dosed as a 25% dilution in Silicone L-45 oil
Sex:
male
Dose descriptor:
LD50
Effect level:
< 0.25 mL/kg bw
Remarks on result:
other: Sample dosed undiluted
Sex:
female
Dose descriptor:
LD50
Effect level:
< 1 mL/kg bw
Remarks on result:
other: Sample dosed undiluted
Mortality:
See Table 1 and 2.
Clinical signs:
other: MALES Dosage: 8 mL/kg: Dyspnea at 3 min; death at 7 to 20 min Dosage: 4 mL/kg: sluggishness, dyspnea at 30 min Dosage: 2 mL/kg: Death of 2 at 4 hr Dosage: 1 mL/kg: None noted before death Dosage: 0.5 mL/kg: None noted FEMALES Dosage: 8 mL/kg: Sluggishnes
Gross pathology:
MALES
Dosage: 8 mL/kg: Stomach distended, gas and liquid-filled, injected, walls brittle, glandular portions black; livers brown, firm; pancreas brown; intestines brown and firm near stomach, lower areas red; kidneys brown, firm; spleens enlarged
Dosage: 4 mL/kg: In victims, lungs red; stomach of 1 perforated; livers pale, firm; intestines injected; adrenals red. In survivors, nothing remarkable
Dosage: 2 mL/kg: In victims, clear fluid in thoracic cavity; stomachs enlarged, black, 1 perforated; intestines brown; fluid in abdominal cavity; spleens enlarged. In survivor, nothing remarkable
Dosage: 1 mL/kg: In victims, lungs pink or red. In survivors, nothing remarkable
Dosage: 0.5 mL/kg: Nothing remarkable

FEMALES
Dosage: 8 mL/kg: Stomachs liquid-filled, injected, glandular sections black, firm; livers tan, firm near stomach; intestines tan and firm near stomach, red and injected in lower areas; kidneys tan, firm
Dosage: 4 mL/kg: Similar to above; 1 stomach perforated; 2 with fluid in abdominal cavity
Dosage: 2 mL/kg: Lungs with dark red patches
Dosage: 1 mL/kg: Nothing remarkable




Any other information on results incl. tables

Table 1: Number of animals dead and time range within which mortality occurred when dosed with undiluted sample. 

Dose
(ml/kg
bw)

Mortality (# dead/total)

Time range of deaths (day)

Male

Female

Combined

0.25

 5/5

n/a 

5/5 

 0,1,2

1.0

 n/a

4/5

 4/5

 0

 

Table 2: Number of animals dead and time range within which mortality occurred when dosed with diluted sample

Dose
(ml/kg
bw)

Mortality (# dead/total)

Time range of deaths (hours)

Male

Female

Combined

0.5

 0/5

 n/a

 0/5

-

1.0

 2/5

 0/5

 2/10

 1,2

2.0

 4/5

 0/5

 4/10

 0,1,2

4.0

 3/5

 5/5

 8/10

1,2,5 

8.0

 5/5

5/5 

 10/10

 0

 

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 values of <320 mg/kg for males and <1280 mg/kg for females were determined in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP.