Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January - February 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
1981
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
tris(isopropenyloxy)(vinyl)silane
IUPAC Name:
tris(isopropenyloxy)(vinyl)silane
Constituent 2
Chemical structure
Reference substance name:
Tris(isopropenyloxy)vinylsilane
EC Number:
239-362-1
EC Name:
Tris(isopropenyloxy)vinylsilane
Cas Number:
15332-99-7
Molecular formula:
C11H18O3Si
IUPAC Name:
tris(isopropenyloxy)vinylsilane
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG., CH 4414 Fuellinsdorf, Switzerland
- Age at study initiation: males: 8 weeks, females: 10 weeks
- Weight at study initiation: 180-200 g, females: 180-200 g
- Fasting period before study:
- Housing: groups of 5 in Makrolon type-4 cages.
- Diet (e.g. ad libitum): Kliba rat maintenance diet ad libitum.
- Water (e.g. ad libitum): community tap water ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Five levels, 8 ports capable of accepting a variety of Makrolon animal restraint tubes.
- Exposure chamber volume: the internal active volume for exposure of 40 animals by nose only is one litre.
- Method of holding animals in test chamber: Makrolon tubes of appropriate size.
- Source and rate of air: no information
- Method of conditioning air: the air used for aerosol generation was dried by sequential desiccation.
- System of generating particulates/aerosols: The test article was placed in an automatic syringe pump feeding a nebulizer. The test atmosphere generated was diluted with clean air.
- Method of particle size determination: no
- Treatment of exhaust air: no information
- Temperature, humidity, pressure in air chamber: 20.2°C, relative humidity 0 (value obtained by sequential desiccating system), oxygen concentration 20.9%

TEST ATMOSPHERE
- Brief description of analytical method used: sample dissolved in toluene to a final volume of 100 ml, then analysed by gas chromatography.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no results were reported.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
4.31 mg/l
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality: once per hour during exposure, once after exposure on day 1, twice daily thereafter; clinical signs: once per hour during exposure, once after exposure on day 1, at least once daily thereafter; body weights: Day 1, 8 and 15
- Necropsy of survivors performed: yes - macroscopic changes or abnormalities recorded.
- Other examinations performed: clinical signs.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.31 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: The concentrations of the two samples analysed were 4.1 and 4.5 mg/l.
Mortality:
No mortalities occurred.
Clinical signs:
other: There were slight clinical signs in male and female animals on day 1 after the treatment: apathy and piloerection.
Body weight:
There was no treatment-related body weight change.
Gross pathology:
There were no macroscopic findings upon necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tris(isopropenyloxy)(vinyl)silane has been tested for acute inhalation toxicity in rat in a study conducted according to OECD 403 and in compliance with GLP. No mortalities occurred, and treatment-related effects were confined to piloerection and apathy on the day after administration, in the five male and five female rats treated with an aerosol containing 4.31 mg/l of the test substance. It is concluded that the LD50 is greater than 4.31 mg/l under the conditions of the test.