(3-chloropropyl)triethoxysilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-10-09 to 1995-10-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3-chloropropyl)triethoxysilane

EC Number:

225-805-6

EC Name:

(3-chloropropyl)triethoxysilane

Cas Number:

5089-70-3

Molecular formula:

C9H21ClO3Si

IUPAC Name:

(3-chloropropyl)triethoxysilane

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Crl:CD BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. Portage, MI
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: young adult (age not specified)
- Weight at study initiation: 271 to 276 g
- Fasting period before study: yes, 18-20 hours prior to dosing and returned to feed 3-4 hours after dosing
- Housing: individual suspended wire-mesh cages
- Diet : Purina Certified Rodent Chow, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: yes, for a minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21.7-22.2 °C
- Humidity: 22.6-46.7%
- Air changes (per hr): not specified
- Photoperiod: 12 hours light/ 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.05 mL/kg based on the specific gravity of 0.99 g/mL

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed approximately 1, 3 and 4 hours after test article administration on study day 0, then twice daily (morning and afternoon) thereafter for 14 days. Individual body weights were obtained on study days -1, 0 (initiation), 7 and 14 days (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights, organ weights, histopathology, other: A gross necropsy was performed on all animals euthanized (by carbon dioxide asphyxiation)

Results and discussion

Preliminary study:

RANGE-FINDING STUDY: Prior to initiation of the main LD50 study, a range-finding study was conducted in which groups of one male and one female rat were dosed at levels of 500, 1000, 2000, 3500 and 5000 mg/kg bw. There were no deaths during the range-finding study. Based on these results, 5000 mg/kg bw was selected as the first level on the main study. One group of five male and five females rats was administered single doses at a level of 5000 mg/kg bw (5.05 mL/kg).

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no deaths during the study

Clinical signs:

other: All clinical findings were noted on day 0 and/or day 1. Wet and/or dried yellow urogenital and/or ventral abdominal staining was observed for all ten animals. Soft stool was noted for six animals. One male rat had mucoid feces. There were no other clinica

Gross pathology:

There were no necropsy findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity with (3-chloropropyl)triethoxysilane (CAS 5089-70-3; EC 225-805-6), conducted according to EPA OPP 81-1 Test Guideline (similar to the now deleted OECD Test Guideline 401) and in compliance with GLP, the LD50 was concluded to be greater than 5000 mg/kg bw in male and female rats.