[ Recommended therapeutic dose of Carctol® for human consumption was 4-gm/70 kg/day ]

I. ACUTE TOXICITY STUDY

(A) By ORAL ROUTE

1. L.D.50
It could not be determined as there was no mortality in the treated groups of rats and mice , even when 30 times of drug as compared to optimum therapeutic does for human consumption was administered.

Moreover, no behavioral changes were observed in test animals during first 48 hrs.of drug treatment.

2. TEST ANIMALS
- Rats and Mice

3. NUMBER
- 30 Rats of either sex, weighing 150-200 gms.
- 30 Mice of either sex, weighing 30-50 gms.

4. DOSE LEVELS
The administered dose levels varied between ten, twenty and thirty fold of optimum therapeutic does of Carctol® in human patients.

5. SIGNS AND TOXICITY
NO mortality or behavioral changes were observed in the experimental animal first 48 hrs of drug study

6. EFFECTS ON ORGANS
- Not studied

(B) BY INTRAPERITONEAL ROUTE

1.TEST ANIMALS
- Rats and Mice

2. NUMBER
- 6 Rats and 6 Mice

3. DOSE LEVELS
- Five fold of normal therapeutic dose of Carctol®

4. MORTALITY
- No death occurred during first 48 hrs. of drug study

II SUBACUTE TOXICITY STUDY

1. TEST ANIMA
- Rats of either sex, weighing 150-200 gms

2. NUMBER
- Two groups of ten each

3. DOSE LEVELS
(a) The first group received optimum therapeutic dose of Carctol®
(b) The second group received double the dose

4. DOSING VEHICLE
The test preparation was mixed in normal animal diet with the help of water and milk.

5. DOSING REQUIRED
Five days a week

6. SIGNS OF TOXICITY
No major signs of toxicity were observed in the test animals

7. EFFECTS ON ORGANS
Not studied

III PRESENCE/ABSENCE OF STEROIDS

Supplied individual constituents and the finished product of Carctol® of did not give positive tests for steroids.

COMMENTS

In view of these findings, Carctol® seems to be a fairly safe herbal product for human Consumption. It is recommended therefore that initial clinical trials of Carctol® may be a limited number of patients of proven diagnosis of malignancies.