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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 abdominal staining. The test material induced hypoactivity in five animals. All animals appeared to be normal by day 4 or earlier and throughout the remainder of the study.
Body weight:
There were no remarkable changes or differences observed in body weights.
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.