Triethoxy(vinyl)silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 May to 27 Aug 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxy(vinyl)silane

EC Number:

201-081-7

EC Name:

Triethoxy(vinyl)silane

Cas Number:

78-08-0

Molecular formula:

C8H18O3Si

IUPAC Name:

triethoxy(vinyl)silane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Labs Inc., Portage, MI, USA
- Age at study initiation: 8-12 wk
- Weight at study initiation: 216-349 g
- Fasting period before study: 18-20 h
- Housing: 1/suspended wire mesh cage
- Diet: certified rodent LabDiet5002, PMI Nutrition International, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6 to 22.3
- Humidity (%): 41.3-61.0
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 1998-05-13 To 1998-06-12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.56 ml/kg bw

Doses:

3846, 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation for mortality 1, 3, 4 h, then twice daily for 14 days; clinical observations 1, 3, 4 h then daily for 14 days; body weights on days -1, 0, 7, 14.
- Necropsy of survivors performed: yes, the major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.

Statistics:

None given.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Dose-related mortality. 2 males and 1 female died at the highest tested dose of 5000 mg/kg bw, and 2 females of the lower dose group died. (See also table below.) All deaths occured within four days of dosing.

Clinical signs:

other: The majority of animals had wet or dry deposits round the mouth, anogenital or urogenital areas, or on the trunk or limbs. Impaired coordination, hypoactivity and tremors occured in both sexes. Mucoid faeces, ocular discharge or laboured breathing occured

Gross pathology:

No clear treatment-related effect. One female that died had an unspecified 'white precipitate' in the kidneys. At terminal necropsy no gross findings for any animal were observed.

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity, and time range within which mortality occurred

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (days)	Number with evident toxicity (#/total)
	Male	Female	Combined			Male	Female	Combined
3846	0/5	2/5	2/10	0-4	Impaired coordination Hypoactive Tremors mucoid faeces Ocular discharge Laboured breathing	2/5 3/5 0/5 0/5 0/5 0/5	5/5 4/5 4/5 0/5 2/5 1/5	7/10 7/10 4/10 0/10 2/10 1/10
5000	2/5	1/5	3/10	3-4	Impaired coordination Hypoactive Tremors mucoid faeces Ocular discharge Laboured breathing	5/5 4/5 1/5 1/5 0/5 0/5	5/5 2/5 2/5 0/5 4/5 0/5	10/10 6/10 3/10 1/10 4/10 0/10

 

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

In an acute oral toxicity study conducted in compliance with the now deleted OECD 401, and in accordance with GLP, an LD50 in excess of 5000 mg/kg bw was identified. There was evidence of systemic toxicity at 5000 and 3846 mg/kg bw; impaired muscle coordination, hypoactivity, tremors and clear ocular discharge. Mucoid feces and laboured breathing were each noted for animals that died. All surviving animals appeared normal by day 13 of the observation period.