Testing Information

Testing Status of Agents at NTP

Ginseng

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http://ntp.niehs.nih.gov/go/13254

SUMMARY OF DATA FOR CHEMICAL SELECTION

Ginseng and Ginsenosides

50647-08-0

  1. BASIS OF NOMINATION TO THE CSWG
  2. INPUT FROM GOVERNMENT AGENCIES/INDUSTRY
  3. ACTION BY CSWG
  4. CHEMICAL IDENTIFICATION
  5. EXPOSURE INFORMATION
    1. Environmental Occurrence
    2. Production and Producers
    3. Production/Import Levels
    4. Use Pattern
    5. Human Exposure
    6. Regulatory Status
  6. EVIDENCE FOR POSSIBLE CARCINOGENIC ACTIVITY
    1. Human Data
    2. Animal Data
    3. Short-Term Tests
    4. Metabolism
    5. Other Biological Effects
    6. Structure-Activity Relationships
  7. References
Appendix 1

 

BASIS OF NOMINATION TO THE CSWG

Ginseng and ginsenosides are presented to the CSWG as part of a review of botanicals used as dietary supplements. Worldwide, ginseng production is a $3 billion industry. Asia is the largest market; 80 percent of American ginseng is exported to Asia. Ginseng is also a popular herbal remedy in the US, with five to six million persons using it even before the recent boom in the herbal supplement industry. Although ginseng root is commonly used, a standardized ginseng extract, GinsanaTM, with annual sales of over $40 million, is the most popular encapsulated form.

Numerous reports of adverse effects from products containing ginseng have been filed with the US Food and Drug Administration (FDA). The literature also documents "ginseng abuse syndrome" among regular users. The chronic effects of ginseng are not well characterized; studies of some components suggest anticarcinogenic activity.

INPUT FROM GOVERNMENT AGENCIES/INDUSTRY

The American Botanical Council provided monographs on Asian Ginseng (Botanical Series - 303) and American Ginseng (Botanical Series - 308) to assist with this project and indicated that their study of ginseng products will not be available until next year.

SELECTION STATUS

ACTION BY CSWG: 9/16/98

Studies requested:

Parallel testing of GinsanaTM and RB1 ginsenoside for the following tests:

- Carcinogenicity studies
-Genotoxicity including standard mammalian assays and the in vivo micronucleus test
-Reproductive toxicity

Priority: High

 

Rationale/Remarks:

-Significant human exposure
-One of the most popular herbal supplements in the US market; GinsanaTM is a standardized extract that controls half of this market
-Little information on toxicity available
-Active ingredients may be dammaranes; RB1 ginsenoside is a commercially available dammarane found in ginseng
-Possibility that these compounds may have anticarcinogenic activity should also be considered


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