Dichloro(methyl)(vinyl)silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dichloro(methyl)(vinyl)silane

EC Number:

204-710-3

EC Name:

Dichloro(methyl)(vinyl)silane

Cas Number:

124-70-9

Molecular formula:

C3H6Cl2Si

IUPAC Name:

dichloro(methyl)vinylsilane

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Charles River Deutschland, Sulzfeld, Germany.

- Age at study initiation: 8-11 weeks

- Fasting period before study: over night (maximum of 20 hours, until 3-4 hours after administration of the test substance)

- Housing: 3 animals per sex/cage, in labelled Macrolon cages, containing purified sawdust as bedding material.

- Diet: standard pelleted laboratory animal diet (ad libitum), from Altromin.

- Water: Tap water (ad libitum)

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 21°C ± 3°C

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE

- Concentration in vehicle: Dehydrated olive oil with silica gel (3:1) (density:0.9139 g/ml)

- Amount of vehicle (if gavage): Dehydrated olive oil with silica gel (3:1) (density: 0.9139 g/ml)

- Justification for choice of vehicle: The vehicle was selected on request of the sponsor and based on the formulations performed at NOTOX.




MAXIMUM DOSE VOLUME APPLIED: 10ml/kg body weight

Doses:

200 mg/kg and 2000 mg/kg

No. of animals per sex per dose:

3M, 3F/200 mg/kg, 3F/2000mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Mortality and viability observations were carried out twice, daily. Body weight measurements were taken on day 1 (pre-administration), 8 and 15 and at death (if found dead after day 1).

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Examinations for clinical signs were carried out at periodic intervals on the day of dosing (day 1) and once daily thereafter until day 15. The symptoms, their time of onset, degree and duration were recorded and graded according to fixed scales.

Statistics:

No statistical analysis was performed.

Results and discussion

Mortality:

All animals died at the 2000 mg/kg dose level.

Clinical signs:

other: At the 200 mg/kg exposure level the animals showed hunched posture, piloerection, salivation and lethargy. The 2000 mg/kg dose level the animals showed lethargy, clonic spasms, hunched and flat posture, uncoordinated movements, slow breathing, piloerectio

Gross pathology:

Dark red discolouration of the G.I tract, forestomach, left liver and mesenteric lymph node; pale discolouration of the kidney (one or both). macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.

Other findings:

None reported.

Any other information on results incl. tables

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

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)
	Male	Female	Combined
200	0/3	0/3	0/6	-
2000	-	3/3	3/3	2

 

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value within the range of 200-2000mg/kg bw was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.