The two acute oral toxicity studies in animals were based on the maximum recommended dose for an adult of 22.5 grams per day assuming an average adult human weight of 60 kilograms or 132 pounds.
According to the provisions in relevant literatures of the Ministry of Public Health, the acute toxicity experiments would be best conducted on two kinds of animals, therefore the test substance's (Liver No. 1™) toxicity was tested accordingly.
Summary Acute Oral Toxicity Study on Mice:
The study took 20 Kunming white mice (10 males and 10 females) with weights between 18-22 grams. The mice were abstained from food but not from water for 12 hours prior to dosing the test substance (Liver No. 1™). Then the test substance was given orally 2 grams each time per mouse with 8 hours intervals, 3 times daily, with a total of 6 grams per mouse daily. This dosage represented approximately 800 times the adult's maximum recommended dosage, assuming an average human weight of 60 kilograms or 132 pounds. The test substance was given to the mice continuously for 7 days and the mice were observed daily.
All signs and symptoms of toxicity and deaths were recorded accordingly. It was found that there was no case of death, their hairy complexions were smooth and activities were normal. After a week, all vital internal organs, such as hearts, livers, lungs, spleens and kidneys etc., of the mice were observed by naked eyes and under microscope and no marked pathological change was found.
According to pharmacopoeia standards, when LD50 is too small to be measured, the measurement of maximum survivability can be used by observing the animal's survivability after taking the test substance of more than 100 times of adult's oral dosage for the test substance to be considered safe.
In conclusion, this study has shown that the maximum survivability volume and concentration of this test substance were given to mice daily, for 7 days, and no abnormal reaction was found, with the maximum survivability being 800 times. This shows that, with the recommended oral dosage, Liver No. 1™ has no toxic effect, and is safe and reliable.
Summary Acute Oral Toxicity Study on Rats:
The method of this study was very similar to the above study. It took 20 Wistar white rats (10 males and 10 females) with weights between 162.3-203.5 grams. The rats were abstained from food but not from water for 12 hours prior to dosing the test substance (Liver No. 1™). Then the test substance was administered by means of pouring in stomach via mouth 13.7175 grams each time per rat with 8 hours intervals, 3 times daily, totaling of 41.1525 grams per rat daily. This dosage represented approximately 600 times the adult's maximum recommended dosage, assuming an average human weight of 60 kilograms or 132 pounds. Regular food and water intakes were allowed after. The test substance was given to the rats continuously for 7 days and the rats were observed during all those days.
All signs and symptoms of toxicity and deaths were recorded accordingly. It was found that there was no case of death, their general conditions were normal and activities were normal. After a week, the vital internal organs, such as hearts, livers, lungs, spleens and kidneys etc., of all the rats were observed by naked eyes and under microscope, and no marked pathological change was found.
This study has shown that the maximum survivability volume and concentration of this test substance were given to rats daily, with a continuous 7-days observation, and no abnormal reaction was found, with the maximum survivability being 600 times. Therefore, the clinical dosage of Liver No. 1™ is safe with no toxic effect.
