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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1683

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, the Netherlands
- Age at study initiation: no information
- Weight at study initiation: males 85-99 g; females 71-90 g
- Fasting period before study: overnight
- Housing: groups of five in stainless steel cages
- Diet: stock diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/-1°C
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12:12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
20 ml/kg bw
No. of animals per sex per dose:
10 male and 10 female animals
Control animals:
no
Details on study design:
- Initial screening was conducted to find general level of acute toxicity - results not presented in report.
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: clinical observations were frequent in the first 4 hours post-treatment, then at least once daily for the 14 day observation period; weighing was carried out weekly.
- Necropsy of survivors performed: yes - gross examination only.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Remarks on result:
other: The highest dose tested was 20 ml/kg bw, which is equivalent to approximately 18 g/kg bw
Mortality:
One male rat died on the second day post treatment.
Clinical signs:
During the first four hour period sluggishness, ataxia and rough coats were observed. Thereafter most of the rats recovered gradually, looking healthy by end of observation period.
Body weight:
Individual body weight of survivors indicated normal growth.
Gross pathology:
Macroscopic examination at autopsy revealed light, discoloured kidneys in all rats. No other treatment-related gross alterations were observed.

Any other information on results incl. tables

Dose test substance (ml/kg bw)

Mean body weight (g) on day

Mortality

dead out of 10

0

7

14

0

7

14

Males

Females

Males

Females

20

93

135

183

83

123

142

1

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Tris(isopropenyloxy)(vinyl)silane has been tested according to OECD 401. The following clinical signs were observed after ten male and ten female Wistar rats were dosed with 20ml/kg bw: sluggishness; ataxia and rough coats. A single male died on the second day. It is concluded that the LD50 is greater than 20 ml/kg bw, which is equivalent to approximately 18000 mg/kg, based on a density of 0.9 g/cm³.