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Diss Factsheets

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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The GLP status of the study is uncertain.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Remarks:
Although a statement regarding GLP was not available with the study report, it is known that this laboratory conducted studies in compliance with GLP at this time.
Test type:
other: LD50
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethoxyvinylsilane
EC Number:
220-449-8
EC Name:
Trimethoxyvinylsilane
Cas Number:
2768-02-7
Molecular formula:
C5H12O3Si
IUPAC Name:
ethenyltrimethoxysilane
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Hilltop Wistar albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 200- 300g

Administration / exposure

Route of administration:
other: intubation
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: not reported

Doses:
16.0, 8.0, 4.0, 2.0 and 1.0 ml/kg bw in males; 16.0, 8.0, 4.0 and 2.0 ml/kg bw in females
No. of animals per sex per dose:
45
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Body weights were recorded on days 0, (before dosing), 7 and 14 (prior to termination).

- Necropsy of survivors performed: yes.

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: At necropsy, each animal was subjected to gross pathologic evaluation.
Statistics:
LD50 with 95% confidence limits; males 7.34 (4.61 to 11.7) ml/kg; females 7.46 (5.16 to 10.8) ml/kg. LD50 slopes; males 3.67, females 4.22.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 7.34 - ca. 7.46 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Equivalent to 6899 and 7012 mg/kg bw based on relative density of 0.94 g/cm3
Mortality:
Deaths occurred at 2.5 hours to 4 days.
Clinical signs:
other: Sluggishness, red to brown discharge (around nose, eyes and anus), lacrimation, piloerection, unkempt appearance, prostation, emaciation and unsteady gait were amongst the signs of toxicity observed. Survivors recovered at one to 5 days. With the exceptio
Gross pathology:
At necropsy, there were several instances of dark red kidney section among victims.

Any other information on results incl. tables

 Table 1: Number of animals dead and time range within which mortality occurred.

 

Dose
(ml/kg)

Mortality (# dead/total)

Time range of deaths (days)

Male

Female

Combined

16

 5/5

 5/5

 10/10

 0 and 1

8

 3/5

 3/5

 6/10

 1,2,3,4

4

 0/5

 0/5

 0/10

 

2

 1/5

 0/5

 1/10

 3

1

 0/5

 0/5

 0/10

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral toxicity study, conducted according to OECD Test Guideline 401 with uncertain GLP status, the concluded LD50 values for male and female rats were 7.34 ml/kg and 7.46 ml/kg (equivalent to 6899 and 7012 mg/kg bw based on relative density of 0.94 g/cm3), respectively.