2,8,9-Trioxa-5-aza-1-silabicyclo[3.3.3]undecane, 1,1'-(dithiodi-3,1-propanediyl)bis-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-03-20 - 2004-05-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate test guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

477-700-1

EC Name:

-

Cas Number:

883794-93-2

Molecular formula:

Hill formula: C18H36N2O6S2Si2 CAS formula: C18H36N2O6S2Si2

IUPAC Name:

1-{3-[(3-{2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecan-1-yl}propyl)disulfanyl]propyl}-2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Italy
- Age at study initiation: approx. 6-8 weeks
- Weight at study initiation: approx 193 - 224 g
- Fasting period before study: overnight prior to dosing
- Housing: 3 animals per group in polycarbonate cages 42.5x26.6x18 cm
- Diet (e.g. ad libitum): commercially available rodent diet
- Water (e.g. ad libitum): drinking water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): artifical cycle of 12 h light and 12 h dark each day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle: insoluble solid

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight

CLASS METHOD (if applicable): limit test
- Rationale for the selection of the starting dose: no mortality occured in step 1 (3 animals) testing

Doses:

step 1, 3 animals: 2000 mg/kg bw
step 2, 3 animals: 2000 mg/kg bw

No. of animals per sex per dose:

6 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: immediately upon dosing, approx. 30 min and 2 and 4 h after dosing and daily thereafter for a total of 14 days
- Frequency of weighing: at allocation, immediately prior to dosing (day 1), and on days 2, 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, external and internal gross necropsy

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No mortality occurred.

Mortality:

no mortality

Clinical signs:

other: Following dosing of the first 3 animals, 1 animal appeared ungroomed on days 2 and 3. Complete recovery occurred by day 4. Following dosing of the second 3 animals (step 2), clinical signs were limited to reduced activity, which was noted in the 3 animal

Gross pathology:

No abnormalities were observed in any animal at necropsy examination at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study conducted according to OECD guideline 423 with GLP identified an LD50 of > 2000 mg/kg bw in female rats.