Triethoxypropylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01-10-1991 to 08-10-1991

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)

Deviations:

yes

Remarks:

dose volume exceeded

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxypropylsilane

EC Number:

219-842-7

EC Name:

Triethoxypropylsilane

Cas Number:

2550-02-9

Molecular formula:

C9H22O3Si

IUPAC Name:

triethoxy(propyl)silane

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPFCpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG., D-4799 Borchen.
- Age at study initiation: 8 weeks (males) and 9 weeks (females)
- Weight at study initiation: 147-165 g (males) and 132-142 g (females)
- Fasting period before study: Approx. 16 hours before treatment
- Housing: Macrolon cages, type II. One animal per cage. Animal bedding chips, supplied by Jelu-Werk, J. Ehrler, Industriemehule, D-7092 Rosenberg/Württ.
- Diet: Standard diet ad libitum, ssniff R, Special diet for rats.
- Water: Water was provided ad libitum in drinking water quality from Stadtwerke Bielefeld, using an automatic drinking water system with drinking nipples.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 – 22.5
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 01-10-1991 To: 15-10-1991

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 237 mg/mL
- Justification for choice of vehicle: substance is insoluble in water.
- Lot/batch no. (if required): 8249


MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg (guideline: <= 1 mL/100 g bw)

DOSAGE PREPARATION (if unusual): prepared as emulsion before dosing

Doses:

5110 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: The animals were continuously observed for first 4 to 6 hours after administration and then once daily. The nature of the toxicity as well as the onset, the intensity, and the duration of the signs were recorded. Mortality was checked twice daily (a.m. and p.m.), on weekends only once. The body weights were recorded at the beginning and also 7 and 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, body orifices, body cavities (thoracic and abdominal), and their content.

Statistics:

None given.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 110 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Signs of toxicity were restrained gait, slight to moderate clonic convulsions, slight to moderate mydriasis, and diarrhea in male and female rats. In additions , male animals showed slight hypokinesia, chromoacryorrhea, and piloerection. In one female ani

Gross pathology:

Necropsy and histopathological examinations revealed no substance-related findings

Any other information on results incl. tables

Table 2. Body weights (g) – Individual Values.

Dose (mg/kg bw)	Animal No.	Day 0	Day 7	Day 14
Male animals
5110	1	165	224	243
	2	154	215	237
	3	147	202	227
	4	149	201	224
	5	152	203	226
Female animals
5110	6	142	160	162
	7	136	173	171
	8	136	160	159
	9	135	174	173
	10	132	148	149

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 rats according to the now deleted OECD 401 and in compliance with GLP, the LD50 for triethoxypropylsilane was greater than 5110 mg/kg bw.