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U.S. Department of Health and Human Services

About FDA

Toxicology Studies and Research

Description: Conduct various studies and research on chemical toxicity levels and issue reports/findings to support risk assessment decisions. These studies are supported by an interagency agreement between NIEHS/NTP and FDA to support studies of mutual benefit to FDA and NIEHS/NIH.

Definition: These studies will produce scientific publications and reports on the toxicity of materials regulated by the FDA. The information will be shared with FDA Centers and stakeholders to support risk assessment decisions.

The studies conducted under the Interagency Agreement with the NTP fill data gaps in our understanding of the toxicity of chemicals. In addition, the Nanotechnology Core Facility will enable toxicity studies to be conducted on nanoscale materials, providing the FDA and other stakeholders with an understanding of the principles of toxicity of these materials.

Public Health Outcome: These chemical toxicity level studies and research will help FDA to deepen its understanding in areas such as glucosamine toxicity, AIDS therapeutic toxicity (identify long-term toxicity outcomes using animal models), zinc oxide toxicity, etc. when evaluating the risks of FDA-regulated products.

1. AIDS Therapeutics NTP Studies (1)

Accomplishment:The AIDS Therapeutics Technical Report was presented to the NTP Technical Report Review Committee on April 5, 2011. In practice, AIDS therapeutic agents are increasingly administered to HIV-positive pregnant women with little information on the long-term consequences to noninfected offspring. In this study, rodents in gestation were exposed to drugs used to treat HIV (AZT, 3TC, NVP and NFV) in various combinations. Carcinogenic activity was observed with numerous combinations, with the exception of the AZT, 3TC, and NFV combination that had no carcinogenic activity.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Conduct studies on AIDS Therapeutics

6/1/2008

Completed 6/1/2008

b. Complete studies on AIDS Therapeutics

9/1/2009

Completed 9/1/2009

c. Complete NCTR Toxicity of AIDS Therapeutics Final Report

12/1/2010

Completed 12/1/2010

d. Submit NCTR Toxicity of AIDS Therapeutics Final Report to NTP

4/1/2011

Completed 3/1/2011

Footnotes

  • (1) NTP is an intra-Agency program between NIH and NCTR whereby NIH directs the toxicological research and NCTR performs the research.

2. Usnea Lichen - Usnic Acid Toxicity NTP Studies

Accomplishment:TBD

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Conduct studies on Usnea Lichen - Usnic Acid

6/1/2009

Completed 6/1/2009

b. Complete studies on Usnea Lichen - Usnic Acid

3/15/2011

Completed 3/15/2011

c. Complete NCTR Toxicity of Usnea Lichen - Usnic Acid Final Report

5/1/2011

(10/1/2011)

Completed 2/1/2012

3. Glucosamine - Chondroitin Sulfate Toxicity NTP Study

Accomplishment:TBD

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Conduct studies on Glucosamine - Chondroitin Sulfate

6/1/2010

Completed 6/1/2010

b. Complete studies on Glucosamine - Chondroitin Sulfate

1/15/2011

Completed 1/15/2011

c. Complete NCTR Toxicity of Glucosamine - Chondroitin Sulfate Final Report

7/1/2011

(11/1/2011)

(1/1/2012)

Completed 6/1/2012

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

NIEHS

National Institute of Environmental Health Sciences

NTP

National Toxicology Program

NIH

National Institutes of Health

glucosamine

one of the most common non-vitamin, non-mineral, dietary supplements

Usnea Lichen - Usnic Acid

herb that is used in home remedy

Glucosamine - Chondroitin Sulfate

dietary supplements found naturally in the body that stimulate the formation and repair of articular cartilage and prevent other body enzymes from degrading the building blocks of joint cartilage

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.