Reaction products of [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and triacetoxyvinylsilane.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1999 - February 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

The room temperature fell below the lower range specified in the study protocol; dosing of one female rat was delayed 24 h as a result of some rat diet being found in its cage. The deviations did not affects the overall result of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: information not in study report
- Age at study initiation: not stated
- Weight at study initiation: 70 - 150 g
- Fasting period before study: overnight prior to and ca. 4 hours after dosing
- Housing: individually in metal cages with wire mesh floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 51-69.5
- Air changes (per hr): minimum 19
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.8 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed at least twice daily for mortality and morbidity. Body weights recorded on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female died on Day 3 of the study.

Clinical signs:

other: Piloerection (observed in all animals), hunched posture and walking on toes (two females), abnormal respiration, increased lacrimation and blue/cold extremities (one female), increased salivation (five males and four females), increased sensitivity to tou

Gross pathology:

Macroscopic pathology of one decedent revealed congestion in the subcutaneous tissue, brain, heart, lungs, liver, spleen and kidneys, with gaseous distension observed in the stomach, duodenum and small intestine. There were no abnormalities observed among animals sacrificed at study termination.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute oral toxicity study, conducted according to OECD TG 401 and in compliance with GLP, reported an LD50 of >2000 mg/kg bw.