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Abstract: The test result of acute toxicity in Acne Formula, using mice, is shown as follows:

Doses of Acne Formula, with the equivalent dosage of 186 grams of herbs per kilogram of body weight, were administered using gavage method to mice, and were observed continuously for 7 days for clinical signs and mortality.

During and after the 7th day, all tested mice survived. Their overall condition, food and water intake, as well as weights gained, were all normal. Necropsy performed on the mice showed no change in their clinical pathology.

The test showed LD50* > 186 g herbs /kg.

Based on the proportioned body weight, the maximum tolerance dosage of gavaged administration of Acne Formula solution to the tested mice was 651 times the adult human dosage for the average adult human. This indicates that the Acne Formula has low toxicity and is safe for human consumption.


Details of the Test:

A) Tested Materials:

1. Tested drug: Acne Formula: (Composition: Wild Tuckahoe 12%, Forsythia Fruit 7%, Honeysuckle Flower 7%, Mutan Bark 6%, Dandelion 7%, Trichosanthes Root 7%, Sargassum 7%, Fritillary Bulb 4%, Red Sage Root 10%, Chinese Angelica Root 4%, Hawthorn Fruit 7%, Tangerine Peel 4%, Peach Kernel 4%, Job's Tears Seed 14%). The formula was boiled in water and the solution brought to a concentration of 4.65 g of herbs/ml for the test.

2. Tested animals: First grade NIH mice, weigh between 19 g and 22 g, half male/female, supplied by the Guangdong Medical Laboratory Animals Center. Animal Quality Certificate # 99A030. All mice were kept and fed under normal condition for 3 days before testing.


B) Method & Results:

1. Administration route: By gavage method.

2. Dosage used: After preliminary testing, the mice were fed (gavaged) doses of Acne Formula solution of the highest concentration and the maximum dose volume. None of the tested mice died. Due to the low toxicity of the Acne Formula, LD50 could not be established. Therefore, only the maximum tolerance dosage of the Acne Formula to mice is being tested here.

3. Test procedures: 20 NIH mice between the weights of 19 g and 22 g, half male/female, were administered with concentrated Acne Formula solution stated above. Dosage volume in the equivalence of 0.4 ml/10 g was administered to the mice 1 time for the first day. The mice were then observed for 7 consecutive days for clinical signs and mortality.

4. Test results: Observation has shown that all mice survived during and after the 7th day of testing. Their overall condition, food and water intake, growth and weights gained were all normal. Necropsy performed on the mice showed no change in their clinical pathology.

LD50 > 186 g of herbs/kg in the gavaged administration of Acne Formula solution to mice.

Based on the suggested daily dosage of Acne Formula for adult at 20 g/day (calculated with the average weight for adult at 70 kg), the maximum tolerance dosage of gavaged administration of Acne Formula solution to the tested mice (with an average weight of 20 g) was 651 times the adult human dosage**. For details, see the following table:


Table: Test Result of Acute Toxicity for Acne Formula on Mice



C) Conclusions:

This test has shown that no death occurred in all tested mice when mice were gavaged with dosages of the highest concentration (186 g of herbs/kg) of the Acne Formula solution.

It was also observed that the overall condition, food & water intake, growth and weights gained were all normal for the tested mice. Necropsy performed on tested mice showed no change in their clinical pathology.

LD50 > 186 g of herbs/kg.

Based on proportioned body weights between mice and adult human, the maximum tolerance dosage of Acne Formula solution in mice was 651 times of the human dosage. This indicates that Acne Formula has low acute toxicity and it is safe for human consumption.












Research Institution:Dept of Pharmacology
Guangdong College of Pharmacy
Research Designer:Professor Jiang Tao
Principal Researcher:Professor Jiang Tao
Participating Researcher:Liang Chun Xi
Research Date:June 2000
Contact Person:Professor Jiang Tao
Telephone Number:86-20-34074099
E-mail:tjiang66@21cn.com




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