Tripotassium propylsilanetriolate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1963

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

The study was not compliant with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method: 6 male rats were dosed at 6 and 18 ml/kg by peroral intubation of the undiluted test substance. The observation period was 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxy(methyl)silane

EC Number:

214-685-0

EC Name:

Trimethoxy(methyl)silane

Cas Number:

1185-55-3

Molecular formula:

C4H12O3Si

IUPAC Name:

trimethoxy(methyl)silane

Test animals

Species:

rat

Strain:

other: Carworth Farms-Eliss

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: The rats were reared at the Mellon Institute

- Age at study initiation: 5-6 weeks

- Weight at study initiation: 90-120g

- Fasting period before study: no

- Diet: Rockland complete rat diet

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.9ml

Doses:

16 and 8 ml/kg

No. of animals per sex per dose:

5M

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

Statistics:

The method of moving average was used for calculating the median effective dose (LD50)

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

12.3 mL/kg bw

Remarks on result:

other: (9.98 to 15.3) ml/kg, undiluted.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

11 685 mg/kg bw

Remarks on result:

other: calculated using density = 0.95

Mortality:

Most deaths occurred within the first several hours after dosing.

Clinical signs:

other: The animals were sluggish and unsteady in gait soon after dosing.

Gross pathology:

At autopsy, gross examination revealed congested lungs, mottled livers with prominent acini and some haemorrhage and congestion of the gastrointestinal tract.

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
16.0	4/5	-	4/5	0,1
8.0	0/5	-	0/5	-

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of 12.3 ml/kg (11685 mg/kg) was determined for male rats in a reliable study conducted according to generally accepted scientific principles.