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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dichloro(methyl)(vinyl)silane
EC Number:
204-710-3
EC Name:
Dichloro(methyl)(vinyl)silane
Cas Number:
124-70-9
Molecular formula:
C3H6Cl2Si
IUPAC Name:
dichloro(methyl)vinylsilane

Test animals

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

- Source: Charles River Deutschland, Sulzfeld, Germany.

- Age at study initiation: 8-11 weeks

- Fasting period before study: over night (maximum of 20 hours, until 3-4 hours after administration of the test substance)

- Housing: 3 animals per sex/cage, in labelled Macrolon cages, containing purified sawdust as bedding material.

- Diet: standard pelleted laboratory animal diet (ad libitum), from Altromin.

- Water: Tap water (ad libitum)

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 21°C ± 3°C

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE

- Concentration in vehicle: Dehydrated olive oil with silica gel (3:1) (density:0.9139 g/ml)

- Amount of vehicle (if gavage): Dehydrated olive oil with silica gel (3:1) (density: 0.9139 g/ml)

- Justification for choice of vehicle: The vehicle was selected on request of the sponsor and based on the formulations performed at NOTOX.




MAXIMUM DOSE VOLUME APPLIED: 10ml/kg body weight


Doses:
200 mg/kg and 2000 mg/kg
No. of animals per sex per dose:
3M, 3F/200 mg/kg, 3F/2000mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Mortality and viability observations were carried out twice, daily. Body weight measurements were taken on day 1 (pre-administration), 8 and 15 and at death (if found dead after day 1).

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Examinations for clinical signs were carried out at periodic intervals on the day of dosing (day 1) and once daily thereafter until day 15. The symptoms, their time of onset, degree and duration were recorded and graded according to fixed scales.
Statistics:
No statistical analysis was performed.

Results and discussion

Mortality:
All animals died at the 2000 mg/kg dose level.
Clinical signs:
At the 200 mg/kg exposure level the animals showed hunched posture, piloerection, salivation and lethargy. The 2000 mg/kg dose level the animals showed lethargy, clonic spasms, hunched and flat posture, uncoordinated movements, slow breathing, piloerection, salivation and ptosis. The surviving animals had recovered from the symptoms between days 2 and 3.
Body weight:
The body weight gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
Dark red discolouration of the G.I tract, forestomach, left liver and mesenteric lymph node; pale discolouration of the kidney (one or both). macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.
Other findings:
None reported.

Any other information on results incl. tables

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

 

Dose
(mg/kg
bw)

Mortality (# dead/total)

Time range of deaths (hours)

Male

Female

Combined

200

0/3 

0/3

0/6 

 -

2000

3/3

3/3

 2

 

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value within the range of 200-2000mg/kg bw was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.