Trimethoxyvinylsilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

It was not compliant with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxyvinylsilane

EC Number:

220-449-8

EC Name:

Trimethoxyvinylsilane

Cas Number:

2768-02-7

Molecular formula:

C5H12O3Si

IUPAC Name:

ethenyltrimethoxysilane

Test material form:

liquid

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

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE

- Area of exposure: clipped, intact skin of the trunk

REMOVAL OF TEST SUBSTANCE

- Washing (if done): After the contact period, excess fluid was removed.

Duration of exposure:

24 hours

Doses:

8.0, 4.0 and 2.0 ml/kg bw

No. of animals per sex per dose:

5/sex/dose, except only 3 females dosed at 8.0 ml/kg bw (due to insufficient amount of test article)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:  Observations for skin reaction were made at one hour, 7 days and 14 days after the contact period. Body weights were recorded on day 0 (before application), 7 and 14 (prior to termination). 

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:  At necropsy, each animal was subjected to gross pathologic evaluation.

Statistics:

LD50's were calculated by the moving average method (Thompson, 1947) and are based on a 14-day observation period.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

3.36 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 3158 based on relative density of 0.94 g/cm3

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

4 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 3760 mg/kg bw based on relative density of 0.94 g/cm3

Mortality:

Most deaths occurred at one to 5 days (one rabbit died at 8 days).   

Clinical signs:

other: FEMALES: 8 ml/kg bw : sluggishness, unsteady gait at 3 minutes; marked sluggishness at 15 minutes; prostration at 2 hours. 4 ml/kg bw: Sluggishness, unsteady gait, lacrimation at 17 minutes; unkempt appearance, brown perianal discharge at 1 day. Survivors

Gross pathology:

At necropsy, lungs appeared red and mottled in animals that died.  A few livers were mottled or had red or white foci in animals that died.  No remarkable findings were noted in survivors.  

Other findings:

- Other observations: Skin reaction included erythema, ecchymosis and desquamation. Discomfort, sluggishness, unsteady gait, and prostration were observed.  Survivors recovered at 2 to 3 days.

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 (days)
	Male	Female	Combined
8	4/5	3/3	7/8	1,2,3
4	2/5	3/5	5/10	3,4,5
2	2/5	1/5	3/10	3,8

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal toxicity study, conducted according to a protocol similar to OECD Test Guideline 402 without information about GLP compliance, an LD50 (rabbit) values of 3.36 ml/kg bw for females and 4 ml/kg bw for males (equivalent to 3158 and 3760 mg/kg bw, respectively, based on relative density of 0.94 g/cm3) were determined.