Triethoxy(methyl)silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16.09.1991 to 13.03.1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxy(methyl)silane

EC Number:

217-983-9

EC Name:

Triethoxy(methyl)silane

Cas Number:

2031-67-6

Molecular formula:

C7H18O3Si

IUPAC Name:

triethoxy(methyl)silane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Crédo, FRANCE
- Age at study initiation: 5-7 wk
- Weight at study initiation: 136-228 g
- Fasting period before study: 17-18 hr
- Housing: 5/cage (separate sexes), polycarbonate cages
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
none

MAXIMUM DOSE VOLUME APPLIED: 2.23 ml/kg bw

Doses:

main study: 2007 mg/kg bw
preliminary study: 504, 1008, 2007 mg/kg bw

No. of animals per sex per dose:

main study: 5
preliminary study: 2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (changes to skin and fur, eyes, mucous membranes, respiratory system, circulatory system, autonomic and central nervous system, as well as somato-motor activity and behaviour. Shivering, convulsions, salivation, diarrhoea, lethargy, sleeping and coma were noted with particular attention.)
- Frequency of observations and weighing: deaths and abnormal clinical signs were noted 15 minutes after administration, then 1, 2 and 4 h then daily for 14 days; weighed on day before treatment (day -1), immediately prior to administration of the test substance (day 1), and on Days 8 and 15.
- Necropsy of survivors performed: yes, after the 14 day observation period (Day 15), with particular attention paid to the following organs: liver, heart, kidneys and lungs.

Statistics:

The body weights of the animals were evaluated for each sex. The mean, standard deviation and coefficient of variation were calculated. There were no deaths so an LD50 could not be calculated.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 007 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths at any dose.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 007 mg/kg bw

Based on:

test mat.

Mortality:

No deaths throughout the study.

Clinical signs:

other: Main study (2007 mg/kg bw) Subdued behaviour in all treated animals at 1, 2 and 4 h, no overt clinical effects at Day 2.

Gross pathology:

No remarkable macroscopic findings.

Any other information on results incl. tables

Table 1: Number of animals dead

 

Dose (mg/kg bw)	Mortality (dead/total)
	Male	Female	Combined
504^a	0/2	0/2	0/4
1008^a	0/2	0/2	0/4
2007^a	0/2	0/2	0/4
2007^b	0/5	0/5	0/10

a. preliminary study

b. main study

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 limit test, conducted in compliance with the now deleted OECD 401 and in accordance with GLP (reliability score 1), there was no mortality or marked systemic effect in rats at 2007 mg/kg bw.