Tetrapropyl orthosilicate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17.04.2002 to 21.06.2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrapropyl orthosilicate

EC Number:

211-659-0

EC Name:

Tetrapropyl orthosilicate

Cas Number:

682-01-9

Molecular formula:

C12H28O4Si

IUPAC Name:

tetrapropyl silicate

Details on test material:

- Name of test material (as cited in study report): SILAN TPN
- Substance type: Organosilane
- Physical state: Liquid
- Stability under test conditions: >1 year at 25 oC.
- Storage condition of test material: At room temperature, dry, tightly closed.

Test animals

Species:

rat

Strain:

other: CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 6-7 weeks
- Weight at study initiation: Males: 224-231g and females: 186-205g
- Fasting period before study: yes
- Housing: groups of 2-3 animalsmin MAKROLON cages.
- Diet (e.g. ad libitum): Ad libitum, but discontinued approximately 16 hours before treatment.
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 55 ±15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.04.2002 To: 17.05.2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.17 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Three

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Observations on mortality were made at least once per day. Clinical observations were performed before and immediately, at 5, 15, 30 and 60 minutes, as well as at 3, 6 and 24 hours after administration. Surviving animals were observed for 14 days. During the follow-up period, changes in skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system, somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, and thereafter each working day. Attention was also paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: yes
- Other examinations performed: Individual body weights were recorded before administration of the substance and thereafter weekly up to the end of the study, and at sacrifice. On day 15 all surviving animals were sacrificed, dissected and inspected macroscopically for gross pathological changes. Animals that survived longer than 24 hours had a microscopic examination of all organs that showed evident lesions. Autopsy and macroscopic examinations of animals that died prematurely would have been conducted as soon as possible after death.

Statistics:

None conducted as method is not intended to allow the calculation of a precise LD50 value.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths occurred.

Mortality:

No mortality.

Clinical signs:

other: No clinical signs of systemic toxicity were recorded.

Gross pathology:

No abnormalities were found at macroscopic postmortem examination of the animals.

Other findings:

No other findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study conducted to OECD 423 and to GLP (reliability score 1) the oral LD50 value for tetrapropyl orthosilicate in CD rats was established to exceed 2000 mg/kg bw. There were no clinical signs of toxicity, affects on body weights or macroscopic findings.

Executive summary:

SILAN TPN was administered orally by gavage to six CD rats (3/sex) at 2000 mg/kg bw. Animals were then observed daily and weekly determinations of body weight were conducted. Macroscopic examination was performed after terminal sacrifice on day 15. None of the six CD rats died, oe showed clinical signs of systemic toxicity. All animals gained body weight within the study period, and no abnormalities were found at macroscopic postmortem examination of the animals. The oral LD₅₀ value for SILAN TPN in CD rats was established to exceed 2000 mg/kg bw.