2-(3,4-epoxycyclohexyl)ethyltriethoxy silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate national standard method.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Aminals, Section 81-1. And: TSCA Health Effects Test Gudelines, 40 CFR 798.1175.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-050-4

EC Name:

-

Cas Number:

10217-34-2

Molecular formula:

C14H28O4Si

IUPAC Name:

triethoxy(2-{7-oxabicyclo[4.1.0]heptan-3-yl}ethyl)silane

Details on test material:

Test article ID (as cited in the study): Y-4036 is beta-(3,4-epoxycyclohexyl)ethyltriethoxysilane
Molecular formula: C13H26O4Si
Molecular weight: 274,43
Physical state: Clear, colorless liquid
Analytical purity: 98.3%
Lot/batch no: 16912-29
Source: OSi Specialities, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591
Test article receipt: 1995-09-18 (expiration date was not provided)
Stability under test conditions: Stable
Storage condition of test material: At room temperature; protected from exposure to light
Certificate of analysis: see appendix IV (GC, FTIR, GC/MS)

Test animals

Species:

other: Albino 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. Kingston, NY
- Age at study initiation: young adult
- Weight at study initiation: 236 to 251 grams at initiation of dosing
- Housing: Individual suspended wire-mesh cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc., in accordance with Standard Operating Procedures
- Fasting period: The rats were fasted approximately 18 to 20 hours prior to dosing and returned to feed 3 to 4 hours after dosing
- Diet (e.g. ad libitum): Purina Certified Rodent Chow #5002, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum.
- Acclimation period: The animals were acclimated to laboratory conditions for a minimum of seven days prior to initiation of dosing.

ENVIRONMENTAL CONDITIONS
- Temperature: 71.8-72.1 °F
- Humidity: 21-47.1 %
- Photoperiod (12 hrs dark /12 hrs light):

IN-LIFE DATES: From: To: no details given

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg

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: on initiation day 1, 3 and 4 hours after dose and then daily for 14 days; weighing on study days -1, 0 (initiation), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality, necrosy

Results and discussion

Preliminary 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. There were no deaths during the range-finding study. Based on these results, 5000 mg/kg was selected as the first level on the main study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: All clinical findings were noted within three days of dosing. Dried red material around the eye(s), nose and/or mouth was observed for seven animals. Six rats had wet and/or dried yellow urogenital and/or ventral

Gross pathology:

Effects on organs:
No treatment related findings.

Any other information on results incl. tables

	Mean body weights (days -1/0/7/14) (g)		Clinical Observations
Dose (mg/kg bw)	Male	Female	Male	Female
5000	269/243/308/349	264/239/286/298	dried red material around the eye(s), nose and/or mouth; 2 animals	dried red material around the eye(s), nose and/or mouth; 5 animals
			dried yellow urogenital staining; 2 animals	wet and/or dried yellow urogenital and/or ventral abdominal staining; 4 animals
			Hypoactive; 1 animal	Hypoactive 4 animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study conducted according a appropriate guideline, identified a LD50 range of > 5000 mg/kg bw in female and male rats, respectively. No treatment related findings were noted up to the highest dose tested.