Trichloro(methyl)silane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal 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:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 2-3kg

- Diet: commercial diet, ad libitum

- Water: municipal water, ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Rabbits were immobilized during a 24-hour contact period. The test material was retained under impervious sheeting on the clipped, intact skin of the trunk. Doses were varied by adjusting the volume or weight of the test material. After the contact period, excess fluid was removed to diminish
ingestion.

Duration of exposure:

24 hours

Doses:

2, 1 and 0.5 mL/kg

No. of animals per sex per dose:

4/sex/dose

Control animals:

no

Details on study design:

Observations for skin reaction were made at one hour, 7 days and 14 days after the contact period.
Animal weights were recorded at 0 days (before dose), 7 days and 14 days. At death, each animal was subjected to gross pathologic evaluation.

Statistics:

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

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1.41 mL/kg bw

95% CL:

0.925 - 2.16

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

0.841 mL/kg bw

95% CL:

0.55 - 1.28

Mortality:

Details provided below

Clinical signs:

other: MALES Dosage: 2 mL/kg Signs of Toxicity: none noted Dosage: 1 mL/kg Signs of Toxicity: Unsteady gait at 1 day, Recovery at 2 days Dosage: 0.5 mL/kg Signs of Toxicity: Unsteady gait in 1 at 1 day FEMALES Dosage: 2 mL/kg Signs of Toxicity: none

Gross pathology:

MALES
Dosage: 2 mL/kg
Gross Pathology: Livers mottled brown and red

Dosage: 1 mL/kg
Gross Pathology: nothing remarkable

Dosage: 0.5 mL/kg
Gross Pathology: nothing remarkable

FEMALES
Dosage: 2 mL/kg
Gross Pathology: nothing remarkable

Dosage: 1 mL/kg
Gross Pathology: In animals that died, lungs with dark red patches. In survivor, nothing remarkable

Dosage: 0.5 mL/kg
Gross Pathology: nothing remarkable

Other findings:

MALES
Dosage: 2 mL/kg
Skin Irritation: Necrosis, peeling; edema at death

Dosage: 1 mL/kg
Skin Irritation: Edema, necrosis, fissuring; scabs, peeling at 14 days

Dosage: 0.5 mL/kg
Skin Irritation: As above for 1 ml/kg dose

FEMALES
Dosage: 2 mL/kg
Skin Irritation: Necrosis, peeling

Dosage: 1 mL/kg
Skin Irritation: Edema, necrosis, fissuring, peeling observed through 14 days

Dosage: 0.5 mL/kg
Skin Irritation: Edema, necrosis, peeling; scabs at 14 days

Any other information on results incl. tables

Table 1: Number of animals dead and time range within which mortality occurred

 

Dose (ml/kg bw)	Mortality (# dead/total)			Time range of deaths (days)
	Male	Female	Combined
2.0	4/4	4/4	8/8	1,2,3
1.5	0/4	3/4	3/8	4
0.5	1/4	0/4	1/8	6

 

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 values of 1.41 ml/kg bw and 0.841 ml/kg bw for males and females respectively were determined in a reliable study conducted according to generally accepted scientific principles.